Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients

Not Applicable

Terminated

• Conditions: Postoperative Complications; Fluid Overload; Postoperative Period; Fluid Therapy; Pancreas Disease
• Interventions: Drug: Ringer's Acetate

• Registration Number: NCT03553394
• Lead Sponsor: Uppsala University

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.

Study Timeline

• Study First Submitted: 2018-05-23
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-12
• Study Start: 2018-10-01
• Primary Completion: 2021-05-31
• Study Completion: 2022-08-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-06
• Last Update Posted: 2022-10-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Urinary output	2 hours	Difference in urinary output two hours after giving the patient a fluid bolus (Control Group) or awaiting fluid bolus (interventional Group)..

Secondary Outcome Measures

Name	Time	Method
Renal function	48 hours	Renal function after 48 hours
Cumulative fluid balance	48 hours	Difference in cumulative fluid balance
Postoperative complications	90 days	Frequency of postoperative complications in both groups
Mortality	90 days	90-day mortality in both groups
Vasopressin (ADH)	1 day	Levels of vasopressin in serum immediately before and after the operation
Renal replacement therapy	Up to 90 days	The need for renal replacement therapy during the hospital stay
Inotropy	1 week	Postoperative need of inotropic therapy during the stay in the postoperative department
S-osmolality	1 day	S-osmolality immediately before and after the operation

Trial Locations

Locations (1)

Central ICU (CIVA), Uppsal university hospital; 🇸🇪 Uppsala, Sweden