Trial Outcomes & Findings for Resuscitation With Plasma in Surgical and Trauma Patients With Septic Shock (NCT NCT03366220)
NCT ID: NCT03366220
Last Updated: 2022-04-13
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and at 24 hours
Results posted on
2022-04-13
Participant Flow
Patients with a sepsis screening score \> or equal to 4 (which indicates potential sepsis) and with a suspected source of infection were enrolled, and they were later randomized if septic shock developed, per the protocol. Only 8 enrolled patients progressed to septic shock, and therefore only 8 participants were randomized and started the protocol.
Participant milestones
| Measure |
Initial Resuscitation With Plasma
Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
|
Initial Resuscitation With Balanced Crystalloids
Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Resuscitation With Plasma in Surgical and Trauma Patients With Septic Shock
Baseline characteristics by cohort
| Measure |
Initial Resuscitation With Plasma
n=4 Participants
Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
|
Initial Resuscitation With Balanced Crystalloids
n=4 Participants
Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.75 years
STANDARD_DEVIATION 9.81 • n=5 Participants
|
58 years
STANDARD_DEVIATION 9.09 • n=7 Participants
|
44.37 years
STANDARD_DEVIATION 9.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and at 24 hoursPopulation: Data was not collected at end of initial bolus of fluid administration (about 3 hours) and 24 hours for one participant in the initial resuscitation with balanced crystalloids arm.
Outcome measures
| Measure |
Initial Resuscitation With Plasma
n=4 Participants
Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
|
Initial Resuscitation With Balanced Crystalloids
n=4 Participants
Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
|
|---|---|---|
|
Glycocalyx Breakdown as Assessed by Syndecan-1 Levels
0 hours
|
260.87 ng/mL
Standard Deviation 455.79
|
390.67 ng/mL
Standard Deviation 169.66
|
|
Glycocalyx Breakdown as Assessed by Syndecan-1 Levels
2 hours
|
294.03 ng/mL
Standard Deviation 499.12
|
383.53 ng/mL
Standard Deviation 122.26
|
|
Glycocalyx Breakdown as Assessed by Syndecan-1 Levels
end of initial bolus of fluid administration (about 3 hours)
|
278.22 ng/mL
Standard Deviation 456.24
|
337.37 ng/mL
Standard Deviation 220.03
|
|
Glycocalyx Breakdown as Assessed by Syndecan-1 Levels
12 hours
|
291.28 ng/mL
Standard Deviation 496.24
|
350.43 ng/mL
Standard Deviation 196.62
|
|
Glycocalyx Breakdown as Assessed by Syndecan-1 Levels
24 hours
|
241.16 ng/mL
Standard Deviation 349.15
|
285.34 ng/mL
Standard Deviation 45.10
|
PRIMARY outcome
Timeframe: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hoursPopulation: Data was not collected at end of initial bolus of fluid administration (about 3 hours) and at 24 hours for one participant in the initial resuscitation with balanced crystalloids arm.
Outcome measures
| Measure |
Initial Resuscitation With Plasma
n=4 Participants
Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
|
Initial Resuscitation With Balanced Crystalloids
n=4 Participants
Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
|
|---|---|---|
|
Glycocalyx Breakdown and Endothelial Leakage as Assessed by Soluble Thrombomodulin (sTM)
0 hours
|
22.44 ng/mL
Standard Deviation 14.94
|
21.29 ng/mL
Standard Deviation 12.22
|
|
Glycocalyx Breakdown and Endothelial Leakage as Assessed by Soluble Thrombomodulin (sTM)
2 hours
|
22.06 ng/mL
Standard Deviation 17.19
|
21.50 ng/mL
Standard Deviation 11.66
|
|
Glycocalyx Breakdown and Endothelial Leakage as Assessed by Soluble Thrombomodulin (sTM)
end of initial bolus of fluid administration (about 3 hours)
|
21.87 ng/mL
Standard Deviation 15.88
|
23.38 ng/mL
Standard Deviation 14.28
|
|
Glycocalyx Breakdown and Endothelial Leakage as Assessed by Soluble Thrombomodulin (sTM)
12 hours
|
21.13 ng/mL
Standard Deviation 12.59
|
22.10 ng/mL
Standard Deviation 11.86
|
|
Glycocalyx Breakdown and Endothelial Leakage as Assessed by Soluble Thrombomodulin (sTM)
24 hours
|
25.69 ng/mL
Standard Deviation 21.02
|
24.43 ng/mL
Standard Deviation 12.78
|
PRIMARY outcome
Timeframe: 0, 2, end of initial bolus of fluid administration(about 3 hours), 12, and 24 hoursPopulation: Data was not collected for this outcome measure.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hoursPopulation: In the plasma arm, sample levels were out of range and thus no value could be obtained for 3 participants at all time points. In the balanced crystalloids arm, sample levels were out of range and thus no value could be obtained for 3 participants at 0, 2, and 12 hours; for 2 at about 3 hours and at 24 hours; and for all 4 at 12 hours--in addition to those with sample levels out of range, there was 1 other participant for whom no data at all were collected at 3 hours and 24 hours.
Outcome measures
| Measure |
Initial Resuscitation With Plasma
n=4 Participants
Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
|
Initial Resuscitation With Balanced Crystalloids
n=4 Participants
Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
|
|---|---|---|
|
Endothelial Leakage and Inflammation as Assessed by Vascular Endothelial Growth Factor (VEGF)
0 hours
|
108.35 pg/mL
Standard Deviation 0
|
61.6 pg/mL
Standard Deviation 0
|
|
Endothelial Leakage and Inflammation as Assessed by Vascular Endothelial Growth Factor (VEGF)
2 hours
|
76.63 pg/mL
Standard Deviation 0
|
97.44 pg/mL
Standard Deviation 0
|
|
Endothelial Leakage and Inflammation as Assessed by Vascular Endothelial Growth Factor (VEGF)
end of initial bolus of fluid administration (about 3 hours)
|
48.02 pg/mL
Standard Deviation 0
|
32.93 pg/mL
Standard Deviation 0
|
|
Endothelial Leakage and Inflammation as Assessed by Vascular Endothelial Growth Factor (VEGF)
12 hours
|
171.29 pg/mL
Standard Deviation 0
|
—
|
|
Endothelial Leakage and Inflammation as Assessed by Vascular Endothelial Growth Factor (VEGF)
24 hours
|
97.44 pg/mL
Standard Deviation 0
|
215.23 pg/mL
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hoursPopulation: Data was not collected for one participant at the end of initial bolus of fluid administration (about 3 hours) and 24 hours in the initial resuscitation with balanced crystalloids arm.
Outcome measures
| Measure |
Initial Resuscitation With Plasma
n=4 Participants
Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
|
Initial Resuscitation With Balanced Crystalloids
n=4 Participants
Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
|
|---|---|---|
|
Sympatho-adrenal Activation as Assessed by Norepinephrine (NE)
12 hours
|
8360.75 pg/mL
Standard Deviation 15166.41
|
1643.5 pg/mL
Standard Deviation 959.69
|
|
Sympatho-adrenal Activation as Assessed by Norepinephrine (NE)
24 hours
|
6579.25 pg/mL
Standard Deviation 10412.6
|
1180.33 pg/mL
Standard Deviation 899.90
|
|
Sympatho-adrenal Activation as Assessed by Norepinephrine (NE)
0 hours
|
3539.75 pg/mL
Standard Deviation 3998.06
|
1757.75 pg/mL
Standard Deviation 718.80
|
|
Sympatho-adrenal Activation as Assessed by Norepinephrine (NE)
2 hours
|
5434.25 pg/mL
Standard Deviation 9411.88
|
2877 pg/mL
Standard Deviation 2349.24
|
|
Sympatho-adrenal Activation as Assessed by Norepinephrine (NE)
end of initial bolus of fluid administration (about 3 hours)
|
5271 pg/mL
Standard Deviation 9131.59
|
2398.33 pg/mL
Standard Deviation 1208.69
|
PRIMARY outcome
Timeframe: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hoursPopulation: Data was not collected for one participant at the end of initial bolus of fluid administration (about 3 hours) and 24 hours in the initial resuscitation with balanced crystalloids arm. Sample levels were out of range and thus no value could be obtained for one participant at 24 hours in the initial resuscitation with balanced crystalloids arm.
Outcome measures
| Measure |
Initial Resuscitation With Plasma
n=4 Participants
Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
|
Initial Resuscitation With Balanced Crystalloids
n=4 Participants
Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
|
|---|---|---|
|
Sympatho-adrenal Activation as Assessed by Epinephrine (Epi)
0 hours
|
239 pg/mL
Standard Deviation 139.90
|
87.25 pg/mL
Standard Deviation 42.01
|
|
Sympatho-adrenal Activation as Assessed by Epinephrine (Epi)
12 hours
|
143.75 pg/mL
Standard Deviation 113.70
|
138.25 pg/mL
Standard Deviation 42.43
|
|
Sympatho-adrenal Activation as Assessed by Epinephrine (Epi)
24 hours
|
133 pg/mL
Standard Deviation 77.48
|
191 pg/mL
Standard Deviation 108.89
|
|
Sympatho-adrenal Activation as Assessed by Epinephrine (Epi)
2 hours
|
198 pg/mL
Standard Deviation 145.22
|
132 pg/mL
Standard Deviation 34.47
|
|
Sympatho-adrenal Activation as Assessed by Epinephrine (Epi)
end of initial bolus of fluid administration (about 3 hours)
|
226.5 pg/mL
Standard Deviation 210.47
|
160.66 pg/mL
Standard Deviation 148.39
|
PRIMARY outcome
Timeframe: 0, 2, end of initial bolus of fluid administration, 12, and 24 hoursPopulation: Data was not collected for this outcome measure.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 0, 2, end of initial bolus of fluid administration, 12, and 24 hoursPopulation: Data was not collected for this outcome measure.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hoursPopulation: Data was not collected for one participant at the end of initial bolus of fluid administration (about 3 hours) and 24 hours in the initial resuscitation with balanced crystalloids arm.
Outcome measures
| Measure |
Initial Resuscitation With Plasma
n=4 Participants
Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
|
Initial Resuscitation With Balanced Crystalloids
n=4 Participants
Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
|
|---|---|---|
|
Inflammation as Assessed by Interleukin-6 (IL-6)
0 hours
|
2455.043 pg/mL
Standard Deviation 4421.03
|
782.41 pg/mL
Standard Deviation 977.31
|
|
Inflammation as Assessed by Interleukin-6 (IL-6)
2 hours
|
1911.7 pg/mL
Standard Deviation 3571.24
|
189.41 pg/mL
Standard Deviation 121.41
|
|
Inflammation as Assessed by Interleukin-6 (IL-6)
end of initial bolus of fluid administration (about 3 hours)
|
1911.48 pg/mL
Standard Deviation 3587.39
|
109.79 pg/mL
Standard Deviation 9.13
|
|
Inflammation as Assessed by Interleukin-6 (IL-6)
12 hours
|
1076.74 pg/mL
Standard Deviation 2062.13
|
60.02 pg/mL
Standard Deviation 51.39
|
|
Inflammation as Assessed by Interleukin-6 (IL-6)
24 hours
|
296.94 pg/mL
Standard Deviation 529.58
|
29.27 pg/mL
Standard Deviation 20.38
|
PRIMARY outcome
Timeframe: 0, 2, end of initial bolus of fluid administration (about 3 hours) , 12, and 24 hoursPopulation: Data was not collected for one participant at the end of initial bolus of fluid administration (about 3 hours) and 24 hours in the initial resuscitation with balanced crystalloids arm.
Outcome measures
| Measure |
Initial Resuscitation With Plasma
n=4 Participants
Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
|
Initial Resuscitation With Balanced Crystalloids
n=4 Participants
Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
|
|---|---|---|
|
Inflammation as Assessed by Interleukin-8 (IL-8)
end of initial bolus of fluid administration (about 3 hours)
|
763.04 pg/mL
Standard Deviation 1414.59
|
83.13 pg/mL
Standard Deviation 17.28
|
|
Inflammation as Assessed by Interleukin-8 (IL-8)
12 hours
|
632.78 pg/mL
Standard Deviation 1170.42
|
58.84 pg/mL
Standard Deviation 11.39
|
|
Inflammation as Assessed by Interleukin-8 (IL-8)
24 hours
|
158.71 pg/mL
Standard Deviation 242.78
|
43.37 pg/mL
Standard Deviation 10.80
|
|
Inflammation as Assessed by Interleukin-8 (IL-8)
0 hours
|
866.78 pg/mL
Standard Deviation 1599.38
|
180.46 pg/mL
Standard Deviation 184.81
|
|
Inflammation as Assessed by Interleukin-8 (IL-8)
2 hours
|
695.66 pg/mL
Standard Deviation 1276.29
|
93.53 pg/mL
Standard Deviation 34.03
|
PRIMARY outcome
Timeframe: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hoursPopulation: Data was not collected for one participant at the end of initial bolus of fluid administration (about 3 hours) and 24 hours in the initial resuscitation with balanced crystalloids arm. Sample levels were out of range and thus no value could be obtained for one participant at 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hours in the initial resuscitation with plasma arm.
Outcome measures
| Measure |
Initial Resuscitation With Plasma
n=4 Participants
Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
|
Initial Resuscitation With Balanced Crystalloids
n=4 Participants
Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
|
|---|---|---|
|
Inflammation as Assessed by Interleukin-10 (IL-10)
0 hours
|
140.06 pg/mL
Standard Deviation 254.38
|
101.88 pg/mL
Standard Deviation 183.79
|
|
Inflammation as Assessed by Interleukin-10 (IL-10)
2 hours
|
216.59 pg/mL
Standard Deviation 349.54
|
52.50 pg/mL
Standard Deviation 81.70
|
|
Inflammation as Assessed by Interleukin-10 (IL-10)
end of initial bolus of fluid administration (about 3 hours)
|
257.11 pg/mL
Standard Deviation 422.66
|
84.52 pg/mL
Standard Deviation 127.60
|
|
Inflammation as Assessed by Interleukin-10 (IL-10)
12 hours
|
59.79 pg/mL
Standard Deviation 79.01
|
9.20 pg/mL
Standard Deviation 3.93
|
|
Inflammation as Assessed by Interleukin-10 (IL-10)
24 hours
|
23.51 pg/mL
Standard Deviation 22.55
|
6.27 pg/mL
Standard Deviation 1.20
|
PRIMARY outcome
Timeframe: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hoursPopulation: Data was not collected for one participant at the end of initial bolus of fluid administration (about 3 hours) and 24 hours in the initial resuscitation with balanced crystalloids arm.
Outcome measures
| Measure |
Initial Resuscitation With Plasma
n=4 Participants
Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
|
Initial Resuscitation With Balanced Crystalloids
n=4 Participants
Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
|
|---|---|---|
|
Inflammation as Assessed by Interleukin-1α (IL-1α)
0 hours
|
15221.21 pg/mL
Standard Deviation 11064.91
|
7759.09 pg/mL
Standard Deviation 3512.66
|
|
Inflammation as Assessed by Interleukin-1α (IL-1α)
2 hours
|
11724.06 pg/mL
Standard Deviation 8728.74
|
7475.72 pg/mL
Standard Deviation 3752.85
|
|
Inflammation as Assessed by Interleukin-1α (IL-1α)
end of initial bolus of fluid administration (about 3 hours)
|
12305.08 pg/mL
Standard Deviation 10084.78
|
7833.37 pg/mL
Standard Deviation 4661.07
|
|
Inflammation as Assessed by Interleukin-1α (IL-1α)
12 hours
|
7998.79 pg/mL
Standard Deviation 7952.26
|
3770.93 pg/mL
Standard Deviation 2453.76
|
|
Inflammation as Assessed by Interleukin-1α (IL-1α)
24 hours
|
5922.11 pg/mL
Standard Deviation 6274.24
|
1999.86 pg/mL
Standard Deviation 1953.98
|
PRIMARY outcome
Timeframe: 0, 2, end of initial bolus of fluid administration (about 3 hours), 12, and 24 hoursPopulation: Data was not collected for one participant at the end of initial bolus of fluid administration (about 3 hours) and 24 hours in the initial resuscitation with balanced crystalloids arm.
Outcome measures
| Measure |
Initial Resuscitation With Plasma
n=4 Participants
Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
|
Initial Resuscitation With Balanced Crystalloids
n=4 Participants
Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
|
|---|---|---|
|
Inflammation as Assessed by Interleukin-1β (IL-1β)
0 hours
|
17.59 pg/mL
Standard Deviation 29.76
|
2.55 pg/mL
Standard Deviation 1.64
|
|
Inflammation as Assessed by Interleukin-1β (IL-1β)
2 hours
|
7.21 pg/mL
Standard Deviation 10.97
|
1.99 pg/mL
Standard Deviation .98
|
|
Inflammation as Assessed by Interleukin-1β (IL-1β)
end of initial bolus of fluid administration (about 3 hours)
|
8.31 pg/mL
Standard Deviation 13.43
|
2.10 pg/mL
Standard Deviation .81
|
|
Inflammation as Assessed by Interleukin-1β (IL-1β)
12 hours
|
1.95 pg/mL
Standard Deviation 1.35
|
1.48 pg/mL
Standard Deviation .44
|
|
Inflammation as Assessed by Interleukin-1β (IL-1β)
24 hours
|
1.56 pg/mL
Standard Deviation .66
|
1.61 pg/mL
Standard Deviation .26
|
SECONDARY outcome
Timeframe: First 24 hours after initiation of fluid resuscitationData were not collected for 1 participant in the initial resuscitation with plasma arm.
Outcome measures
| Measure |
Initial Resuscitation With Plasma
n=3 Participants
Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
|
Initial Resuscitation With Balanced Crystalloids
n=4 Participants
Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
|
|---|---|---|
|
Total Volume of Fluid Required for Resuscitation After the Initial Bolus of Either Plasma or Crystalloids
|
967.66 mL
Standard Deviation 951.91
|
455 mL
Standard Deviation 530.50
|
SECONDARY outcome
Timeframe: First 24 hours after initiation of fluid resuscitationOutcome measures
| Measure |
Initial Resuscitation With Plasma
n=4 Participants
Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
|
Initial Resuscitation With Balanced Crystalloids
n=4 Participants
Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
|
|---|---|---|
|
Time Until Lactate Normalization
|
15.25 hours
Standard Deviation 27.26
|
3.5 hours
Standard Deviation 7
|
SECONDARY outcome
Timeframe: First 30 days after initiation of fluid resuscitationPopulation: Data were not collected for 2 participants in the initial resuscitation with plasma arm and 2 participants in the initial resuscitation with balanced crystalloids arm.
Outcome measures
| Measure |
Initial Resuscitation With Plasma
n=2 Participants
Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
|
Initial Resuscitation With Balanced Crystalloids
n=2 Participants
Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
|
|---|---|---|
|
Time on Vasopressors
|
70.5 hours
Standard Deviation 92.63
|
14.5 hours
Standard Deviation 10.60
|
SECONDARY outcome
Timeframe: First 30 days after initiation of fluid resuscitationPopulation: Data were not collected for 1 participant in the initial resuscitation with balanced crystalloids arm.
Outcome measures
| Measure |
Initial Resuscitation With Plasma
n=4 Participants
Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
|
Initial Resuscitation With Balanced Crystalloids
n=3 Participants
Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
|
|---|---|---|
|
Number of Days on Ventilator Support
|
13.5 days
Standard Deviation 10.37
|
9 days
Standard Deviation 15.58
|
SECONDARY outcome
Timeframe: First 30 days after initiation of fluid resuscitationOutcome measures
| Measure |
Initial Resuscitation With Plasma
n=4 Participants
Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
|
Initial Resuscitation With Balanced Crystalloids
n=4 Participants
Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
|
|---|---|---|
|
Number of Intensive Care Unit (ICU)-Free Days
|
9.25 days
Standard Deviation 13.20
|
23.5 days
Standard Deviation 22.53
|
SECONDARY outcome
Timeframe: From the time of initiation of fluid resuscitation to the time of hospital discharge (up to about 170 days)Outcome measures
| Measure |
Initial Resuscitation With Plasma
n=4 Participants
Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
|
Initial Resuscitation With Balanced Crystalloids
n=4 Participants
Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
|
|---|---|---|
|
Number of Hospital Days
|
29 days
Standard Deviation 11.16
|
81.5 days
Standard Deviation 86.54
|
SECONDARY outcome
Timeframe: First 30 days after initiation of fluid resuscitationOutcome measures
| Measure |
Initial Resuscitation With Plasma
n=4 Participants
Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
|
Initial Resuscitation With Balanced Crystalloids
n=4 Participants
Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
|
|---|---|---|
|
Mortality
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: First 30 days after initiation of fluid resuscitationPopulation: Data was not collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First 30 days after initiation of fluid resuscitationPopulation: Data was not collected for this outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
Initial Resuscitation With Plasma
Serious events: 4 serious events
Other events: 0 other events
Deaths: 1 deaths
Initial Resuscitation With Balanced Crystalloids
Serious events: 4 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Initial Resuscitation With Plasma
n=4 participants at risk
Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
|
Initial Resuscitation With Balanced Crystalloids
n=4 participants at risk
Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
|
|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/4 • 30 days
|
25.0%
1/4 • 30 days
|
|
Hepatobiliary disorders
Liver failure
|
0.00%
0/4 • 30 days
|
25.0%
1/4 • 30 days
|
|
Gastrointestinal disorders
Clostridium difficile colitis
|
0.00%
0/4 • 30 days
|
25.0%
1/4 • 30 days
|
|
Cardiac disorders
atrial fibrillation requiring multiple cardioversions
|
0.00%
0/4 • 30 days
|
25.0%
1/4 • 30 days
|
|
Renal and urinary disorders
acute renal failure requiring intermittent hemodialysis
|
0.00%
0/4 • 30 days
|
25.0%
1/4 • 30 days
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.00%
0/4 • 30 days
|
25.0%
1/4 • 30 days
|
|
Renal and urinary disorders
acute renal failure requiring continuous renal replacement therapy/intermittent hemodialysis
|
0.00%
0/4 • 30 days
|
25.0%
1/4 • 30 days
|
|
Hepatobiliary disorders
acalculous cholecystitis
|
0.00%
0/4 • 30 days
|
25.0%
1/4 • 30 days
|
|
Eye disorders
medication induced blindness
|
0.00%
0/4 • 30 days
|
25.0%
1/4 • 30 days
|
|
Vascular disorders
Deep vein thrombosis with persistent anemia requiring inferior vena cava filter
|
0.00%
0/4 • 30 days
|
25.0%
1/4 • 30 days
|
|
Blood and lymphatic system disorders
anemia requiring Inferior vena cava filter
|
0.00%
0/4 • 30 days
|
25.0%
1/4 • 30 days
|
|
Blood and lymphatic system disorders
chylothorax
|
0.00%
0/4 • 30 days
|
25.0%
1/4 • 30 days
|
|
Infections and infestations
multiple episodes of severe sepsis secondary to urinary tract infection
|
0.00%
0/4 • 30 days
|
25.0%
1/4 • 30 days
|
|
Infections and infestations
bacteremia
|
0.00%
0/4 • 30 days
|
25.0%
1/4 • 30 days
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
0.00%
0/4 • 30 days
|
25.0%
1/4 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
25.0%
1/4 • 30 days
|
25.0%
1/4 • 30 days
|
|
Renal and urinary disorders
Urinary tract infection
|
25.0%
1/4 • 30 days
|
0.00%
0/4 • 30 days
|
|
Gastrointestinal disorders
Ascending colon perforation
|
25.0%
1/4 • 30 days
|
0.00%
0/4 • 30 days
|
|
Cardiac disorders
Congestive heart failure exacerbation/flash pulmonary edema
|
25.0%
1/4 • 30 days
|
0.00%
0/4 • 30 days
|
|
Renal and urinary disorders
Worsening acute kidney injury requiring continuous renal replacement therapy to be restarted
|
25.0%
1/4 • 30 days
|
0.00%
0/4 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
25.0%
1/4 • 30 days
|
0.00%
0/4 • 30 days
|
|
Nervous system disorders
Traumatic brain injury (tracheostomy & percutaneous endoscopic gastrostomy)
|
25.0%
1/4 • 30 days
|
0.00%
0/4 • 30 days
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Lillian S Kao
The University of Texas Health Science Center at Houston
Phone: (713) 500-6280
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place