Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients

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

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.

Study Overview

• Status: Terminated
• Conditions: Postoperative Complications; Fluid Therapy; Fluid Overload; Pancreas Disease; Postoperative Period
• Intervention / Treatment: Drug: Ringer's Acetate

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 75185
    • Central ICU (CIVA), Uppsal university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Drug: Ringer's Acetate; Will receive a fluid bolus immediately (Ringer's Acetate 5 mls/kg bw) if oliguric/anuric for two consecutive hours; Other Names: Ringer Acetate
No Intervention: Expectant management group; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Miklós Lipcsey, MD, PhD, Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Actual): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Pancreatic Diseases
• Other Study ID Numbers: 2018/147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No