Trial Outcomes & Findings for High Volume Lactated Ringer's Solution and Pancreatitis (NCT NCT02050048)
NCT ID: NCT02050048
Last Updated: 2019-09-06
Results Overview
Patients will be monitored after procedure to see if they develop abdominal pain. If so, serum amylase and lipase blood draws will be completed at least once every 24 hours following procedure to monitor the development of post-ERCP pancreatitis. If patients do not develop abdominal pain following the procedure, research staff will follow up with the patients 5 days and 29 days after the procedure to evaluate for the development of post-ERCP pancreatitis and other related or unrelated complications.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
26 participants
Primary outcome timeframe
Assessed 90 minutes after procedure, 5 days after procedure, and 29 days after procedure
Results posted on
2019-09-06
Participant Flow
Participant milestones
| Measure |
High Volume Group (Intervention Arm)
Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:
* initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour
* LR fluid infusion during the procedure at 5 cc/kg/hr
* Post-procedure bolus of 20 cc/kg over 90 minutes
|
Low Volume Group (Control Arm)
In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
High Volume Group (Intervention Arm)
Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:
* initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour
* LR fluid infusion during the procedure at 5 cc/kg/hr
* Post-procedure bolus of 20 cc/kg over 90 minutes
|
Low Volume Group (Control Arm)
In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Ineligible after ERCP
|
4
|
1
|
Baseline Characteristics
High Volume Lactated Ringer's Solution and Pancreatitis
Baseline characteristics by cohort
| Measure |
High Volume Group (Intervention Arm)
n=14 Participants
Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:
* initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour
* LR fluid infusion during the procedure at 5 cc/kg/hr
* Post-procedure bolus of 20 cc/kg over 90 minutes
|
Low Volume Group (Control Arm)
n=12 Participants
In the low volume group (control arm), patients will receive intravenous Lactated Ringer's solution at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 11.9 • n=93 Participants
|
55.7 years
STANDARD_DEVIATION 18.1 • n=4 Participants
|
57.4 years
STANDARD_DEVIATION 14.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=93 Participants
|
12 participants
n=4 Participants
|
26 participants
n=27 Participants
|
|
BMI
|
29.6 kg/m^2
STANDARD_DEVIATION 6.6 • n=93 Participants
|
25.6 kg/m^2
STANDARD_DEVIATION 3.4 • n=4 Participants
|
27.7 kg/m^2
STANDARD_DEVIATION 5.5 • n=27 Participants
|
|
Creatinine
|
0.83 mg/dL
STANDARD_DEVIATION 0.20 • n=93 Participants
|
0.89 mg/dL
STANDARD_DEVIATION 0.22 • n=4 Participants
|
0.86 mg/dL
STANDARD_DEVIATION 0.21 • n=27 Participants
|
PRIMARY outcome
Timeframe: Assessed 90 minutes after procedure, 5 days after procedure, and 29 days after procedurePatients will be monitored after procedure to see if they develop abdominal pain. If so, serum amylase and lipase blood draws will be completed at least once every 24 hours following procedure to monitor the development of post-ERCP pancreatitis. If patients do not develop abdominal pain following the procedure, research staff will follow up with the patients 5 days and 29 days after the procedure to evaluate for the development of post-ERCP pancreatitis and other related or unrelated complications.
Outcome measures
| Measure |
High Volume Group (Intervention Arm)
n=14 Participants
Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:
* initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour
* LR fluid infusion during the procedure at 5 cc/kg/hr
* Post-procedure bolus of 20 cc/kg over 90 minutes
|
Low Volume Group (Control Arm)
n=12 Participants
Patients will be randomized to receive intravenous Lactated Ringer's solution. In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluid administration may be continued through the 90 minute post-procedure observation period.
|
|---|---|---|
|
Development of Post-ERCP Pancreatitis
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Phase II portion (~1 year)A portion of the study will assess whether there is a significant risk of adverse events related to fluid overload states in the high volume (HV) intervention arm. We anticipate the rate of adverse events in patients randomized to the HV arm to be small. By using more modest, weight based regimens, we aim to optimize benefit while eliminating overly aggressive fluid administration and causing undue harm.
Outcome measures
Outcome data not reported
Adverse Events
High Volume Group (Intervention Arm)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Low Volume Group (Control Arm)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Volume Group (Intervention Arm)
n=14 participants at risk
Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:
* initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour
* LR fluid infusion during the procedure at 5 cc/kg/hr
* Post-procedure bolus of 20 cc/kg over 90 minutes
|
Low Volume Group (Control Arm)
n=12 participants at risk
Patients will be randomized to receive intravenous Lactated Ringer's solution. In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
|
|---|---|---|
|
Hepatobiliary disorders
Liver failure
|
7.1%
1/14
|
0.00%
0/12
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/14
|
8.3%
1/12
|
|
General disorders
Lactic acidosis
|
0.00%
0/14
|
8.3%
1/12
|
Other adverse events
| Measure |
High Volume Group (Intervention Arm)
n=14 participants at risk
Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:
* initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour
* LR fluid infusion during the procedure at 5 cc/kg/hr
* Post-procedure bolus of 20 cc/kg over 90 minutes
|
Low Volume Group (Control Arm)
n=12 participants at risk
Patients will be randomized to receive intravenous Lactated Ringer's solution. In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
35.7%
5/14
|
33.3%
4/12
|
|
General disorders
Fever
|
0.00%
0/14
|
25.0%
3/12
|
|
General disorders
Chills
|
7.1%
1/14
|
8.3%
1/12
|
|
Blood and lymphatic system disorders
Edema
|
0.00%
0/14
|
16.7%
2/12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place