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Clinical Trials/NCT03553394
NCT03553394
Terminated
Not Applicable

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

Uppsala University1 site in 1 country53 target enrollmentOctober 1, 2018

Overview

Phase
Not Applicable
Intervention
Ringer's Acetate
Conditions
Fluid Therapy
Sponsor
Uppsala University
Enrollment
53
Locations
1
Primary Endpoint
Urinary output
Status
Terminated
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
August 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Uppsala University
Responsible Party
Sponsor

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

Arms & Interventions

Standard of care group

Will receive a fluid bolus 5 ml/kg Ringer's Acetate infusion immediately if oliguric/anuric for two consecutive hours (standard of care).

Intervention: Ringer's Acetate

Outcomes

Primary Outcomes

Urinary output

Time Frame: 2 hours

Difference in urinary output two hours after giving the patient a fluid bolus (Control Group) or awaiting fluid bolus (interventional Group)..

Secondary Outcomes

  • Renal function(48 hours)
  • Cumulative fluid balance(48 hours)
  • Postoperative complications(90 days)
  • Mortality(90 days)
  • Vasopressin (ADH)(1 day)
  • Renal replacement therapy(Up to 90 days)
  • Inotropy(1 week)
  • S-osmolality(1 day)

Study Sites (1)

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