Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients
Primary Purpose
Fluid Therapy, Postoperative Period, Postoperative Complications
Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Ringer's Acetate
Sponsored by
About this trial
This is an interventional treatment trial for Fluid Therapy
Eligibility Criteria
Inclusion Criteria:
- Patients going through pancreatic surgery.
Exclusion Criteria:
- If not oliguric (urinary output <0,5 mls/kg/h) during their stay in the postoperative department
- Hemodynamic instability (the need for >0,1 microgram/kg/min of norepinephrine to keep an acceptable mean arterial pressure based on the patients starting mean arterial pressure).
- Patients that do not want to be a part of the study.
- <18 years old
Sites / Locations
- Central ICU (CIVA), Uppsal university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Standard of care group
Expectant management group
Arm Description
Will receive a fluid bolus 5 ml/kg Ringer's Acetate infusion immediately if oliguric/anuric for two consecutive hours (standard of care).
Await fluid therapy for 2 hours. Will NOT receive a fluid bolus if oliguric/anuric for two consecutive hours and a now assessment will be made after two more hours.
Outcomes
Primary Outcome Measures
Urinary output
Difference in urinary output two hours after giving the patient a fluid bolus (Control Group) or awaiting fluid bolus (interventional Group)..
Secondary Outcome Measures
Renal function
Renal function after 48 hours
Cumulative fluid balance
Difference in cumulative fluid balance
Postoperative complications
Frequency of postoperative complications in both groups
Renal replacement therapy
The need for renal replacement therapy during the hospital stay
Mortality
90-day mortality in both groups
Inotropy
Postoperative need of inotropic therapy during the stay in the postoperative department
Vasopressin (ADH)
Levels of vasopressin in serum immediately before and after the operation
S-osmolality
S-osmolality immediately before and after the operation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03553394
Brief Title
Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients
Official Title
The Effects on Fluid Balance and Renal Function Using a Restrictive Fluid Strategy in the Postoperative Setting in Patients With Low Urinary Output Undergoing Pancreatic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Stopped after interim analysis
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Reduced urinary output is a common postoperative issue for patients going through major surgery such as pancreatic surgery. Commonly this is treated by increasing fluid administration to the patients and sometimes also diuretics. However, overloading patients with fluid also have several risks and known complications. Studies have also shown that a short period of decreased urinary output in the postoperative period do not have an increased incidence of acute renal failure. The aim of our study is to investigate the difference in renal function and postoperative complications associated with fluid overload on these patients that are randomized to either receiving a fluid bolus directly when urinary output decreases or to await for a maximum of four hours to see if urinary output increases spontaneously.
Detailed Description
Patents after pancreatic surgery will be included in the study. Oliguric patients (urine output <0.5 ml/kg/h) will be randomized to fluid bolus (5ml/kg Ringer's Acetate in 30 minutes) or no intervention. Primary outcome is difference in urine output two hours after the fluid bolus or no intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fluid Therapy, Postoperative Period, Postoperative Complications, Pancreas Disease, Fluid Overload
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to either receive a fluid bolus immediately when urinary output is decreased for two consecutive hours or to await fluid bolus therapy for two more hours.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of care group
Arm Type
Active Comparator
Arm Description
Will receive a fluid bolus 5 ml/kg Ringer's Acetate infusion immediately if oliguric/anuric for two consecutive hours (standard of care).
Arm Title
Expectant management group
Arm Type
No Intervention
Arm Description
Await fluid therapy for 2 hours. Will NOT receive a fluid bolus if oliguric/anuric for two consecutive hours and a now assessment will be made after two more hours.
Intervention Type
Drug
Intervention Name(s)
Ringer's Acetate
Other Intervention Name(s)
Ringer Acetate
Intervention Description
Will receive a fluid bolus immediately (Ringer's Acetate 5 mls/kg bw) if oliguric/anuric for two consecutive hours
Primary Outcome Measure Information:
Title
Urinary output
Description
Difference in urinary output two hours after giving the patient a fluid bolus (Control Group) or awaiting fluid bolus (interventional Group)..
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Renal function
Description
Renal function after 48 hours
Time Frame
48 hours
Title
Cumulative fluid balance
Description
Difference in cumulative fluid balance
Time Frame
48 hours
Title
Postoperative complications
Description
Frequency of postoperative complications in both groups
Time Frame
90 days
Title
Renal replacement therapy
Description
The need for renal replacement therapy during the hospital stay
Time Frame
Up to 90 days
Title
Mortality
Description
90-day mortality in both groups
Time Frame
90 days
Title
Inotropy
Description
Postoperative need of inotropic therapy during the stay in the postoperative department
Time Frame
1 week
Title
Vasopressin (ADH)
Description
Levels of vasopressin in serum immediately before and after the operation
Time Frame
1 day
Title
S-osmolality
Description
S-osmolality immediately before and after the operation
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients going through pancreatic surgery.
Exclusion Criteria:
If not oliguric (urinary output <0,5 mls/kg/h) during their stay in the postoperative department
Hemodynamic instability (the need for >0,1 microgram/kg/min of norepinephrine to keep an acceptable mean arterial pressure based on the patients starting mean arterial pressure).
Patients that do not want to be a part of the study.
<18 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miklos Lipcsey, MD, PhD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central ICU (CIVA), Uppsal university hospital
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients
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