Trial Outcomes & Findings for Comparative Evaluation of Albumin and Starch Effects in Acute Lung Injury (ALI) (NCT NCT00796419)
NCT ID: NCT00796419
Last Updated: 2017-04-28
Results Overview
Quantity of extravascular lung water (EVLW) measured by transpulmonary thermodilution. Higher measurements of EVLW per kilogram of body weight indicate increased lung injury. Normal values for EVLW are thought to be less than 10 mL/kg.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
31 participants
Primary outcome timeframe
Baseline to Day 5 (120 hours)
Results posted on
2017-04-28
Participant Flow
Critically ill, mechanically ventilated intensive care patients with Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS) and low blood protein levels were recruited from four hospitals in the Southeast United States between May 1, 2009 and October 31, 2015.
Not all consented subjects were treated due to changes in eligibility between the consent and treatment periods or subject withdrawal from the study after consent but prior to treatment. 31 individuals gave consent to participate in the study, however, 4 did not begin the study intervention, resulting in 27 who started treatment.
Participant milestones
| Measure |
Intravenous 5% Human Albumin
Recipients of continuous infusion intravenous furosemide and administration of intravenous 250 milliliters (mL) 5% human albumin every 8 hours for 5 days
|
Intravenous 6% Hetastarch
Recipients of continuous infusion intravenous furosemide and administration of intravenous 250 milliliters (mL) 6% hetastarch every 8 hours for 5 days
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Intravenous 5% Human Albumin
Recipients of continuous infusion intravenous furosemide and administration of intravenous 250 milliliters (mL) 5% human albumin every 8 hours for 5 days
|
Intravenous 6% Hetastarch
Recipients of continuous infusion intravenous furosemide and administration of intravenous 250 milliliters (mL) 6% hetastarch every 8 hours for 5 days
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Comparative Evaluation of Albumin and Starch Effects in Acute Lung Injury (ALI)
Baseline characteristics by cohort
| Measure |
Intravenous 5% Human Albumin
n=13 Participants
Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
|
Intravenous 6% Hetastarch
n=14 Participants
Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 16 • n=5 Participants
|
50 years
STANDARD_DEVIATION 16 • n=7 Participants
|
49 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 5 (120 hours)Quantity of extravascular lung water (EVLW) measured by transpulmonary thermodilution. Higher measurements of EVLW per kilogram of body weight indicate increased lung injury. Normal values for EVLW are thought to be less than 10 mL/kg.
Outcome measures
| Measure |
Intravenous 5% Human Albumin
n=13 Participants
Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
|
Intravenous 6% Hetastarch
n=14 Participants
Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
|
|---|---|---|
|
Change in Extravascular Lung Water (EVLW)
Baseline
|
18.5 mL/kg
Standard Deviation 7.1
|
17.7 mL/kg
Standard Deviation 5.9
|
|
Change in Extravascular Lung Water (EVLW)
Hour 120
|
16.0 mL/kg
Standard Deviation 7.3
|
15.1 mL/kg
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Baseline, Day 1Change in arterial oxygenation measured by arterial blood gas analysis. The partial pressure of O2 in arterial blood to fraction of inspired oxygen ratio (PaO2/FiO2) is a ratio of partial pressure arterial oxygen to fractional inspired inspired oxygen. This ratio is used as an indicator of hypoxemia (low blood oxygen). A PaO2/FiO2 ratio of 200-300 indicates mild ARDS, 100-200 indicates moderate ARDS, and less than 100 indicates severe ARDS.
Outcome measures
| Measure |
Intravenous 5% Human Albumin
n=13 Participants
Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
|
Intravenous 6% Hetastarch
n=14 Participants
Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
|
|---|---|---|
|
Change in Oxygenation (PaO2/FiO2 Ratio)
Baseline
|
191.3 mmHg
Standard Deviation 53.8
|
157.3 mmHg
Standard Deviation 63.0
|
|
Change in Oxygenation (PaO2/FiO2 Ratio)
Day 1
|
213.4 mmHg
Standard Deviation 95.5
|
165.4 mmHg
Standard Deviation 50.8
|
SECONDARY outcome
Timeframe: Day 30The 'ventilator free survival days' in a 30-day period is a previously validated method of comparing groups with respect to mechanical ventilator requirements while adjusting for mortality. This variable represents the number of days in the 30-day period following baseline that the patient is alive and not requiring mechanical ventilation.
Outcome measures
| Measure |
Intravenous 5% Human Albumin
n=13 Participants
Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
|
Intravenous 6% Hetastarch
n=14 Participants
Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
|
|---|---|---|
|
Ventilator-free Days
|
23 days
Interval 0.0 to 24.0
|
23 days
Interval 0.0 to 24.0
|
Adverse Events
Intravenous 5% Human Albumin
Serious events: 4 serious events
Other events: 6 other events
Deaths: 1 deaths
Intravenous 6% Hetastarch
Serious events: 5 serious events
Other events: 6 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Intravenous 5% Human Albumin
n=13 participants at risk
Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
|
Intravenous 6% Hetastarch
n=14 participants at risk
Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
|
|---|---|---|
|
General disorders
Re-hospitalization
|
7.7%
1/13 • Number of events 1 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
0.00%
0/14 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
|
General disorders
Shock
|
0.00%
0/13 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
14.3%
2/14 • Number of events 2 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
7.7%
1/13 • Number of events 1 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
0.00%
0/14 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
|
Hepatobiliary disorders
Acute hepatic injury
|
0.00%
0/13 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
|
General disorders
Bleeding
|
0.00%
0/13 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/13 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/13 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
|
General disorders
Focal weakness
|
0.00%
0/13 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress/failure
|
7.7%
1/13 • Number of events 1 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
0.00%
0/14 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
|
General disorders
Death
|
7.7%
1/13 • Number of events 1 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
21.4%
3/14 • Number of events 3 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
Other adverse events
| Measure |
Intravenous 5% Human Albumin
n=13 participants at risk
Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
|
Intravenous 6% Hetastarch
n=14 participants at risk
Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
|
|---|---|---|
|
General disorders
Systemic hypotension
|
30.8%
4/13 • Number of events 7 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
21.4%
3/14 • Number of events 3 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
|
General disorders
Systemic hypertension
|
7.7%
1/13 • Number of events 1 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
0.00%
0/14 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
|
Blood and lymphatic system disorders
Bleeding/coagulopathy
|
0.00%
0/13 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
28.6%
4/14 • Number of events 6 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
|
Respiratory, thoracic and mediastinal disorders
Worsening pulmonary edema or lung injury
|
15.4%
2/13 • Number of events 2 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/13 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
|
Blood and lymphatic system disorders
Increase in serum amylase or lipase
|
0.00%
0/13 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
|
Infections and infestations
Secondary infection or sepsis
|
0.00%
0/13 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
7.1%
1/14 • Number of events 1 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
|
Cardiac disorders
Pericardial effusion
|
7.7%
1/13 • Number of events 1 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
0.00%
0/14 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
|
Cardiac disorders
Tachycardia
|
7.7%
1/13 • Number of events 1 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
0.00%
0/14 • Adverse events (AEs) will be determined daily from enrollment to 72 hours after the last dose of study drug or any study-related procedure. All deaths, unexpected serious adverse events (SAEs), and worsening renal function (as defined as creatinine greater than or equal to 3.0 mg/dL or urine output less than 500cc/24 hrs) will be followed until 30 days after enrollment in this study.
For purposes of this study, an AE is defined as any unfavorable or unintended change in structure, function, signs, or symptoms different from what is expected in the clinical course of an ALI patient and temporally associated with the use of any study drug (albumin, hetastarch or furosemide) or the performance of a study procedure, regardless of any causal relationship to the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place