Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients

NCT03553394 | Terminated

• 1 other identifier: 2018/147
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluid Therapy; Postoperative Period; Postoperative Complications; Pancreas Disease; Fluid Overload

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Renal function

  48 hours

• Cumulative fluid balance

  48 hours

• Postoperative complications

  90 days

• Renal replacement therapy

  Up to 90 days

• Mortality

  90 days

Study Arms (2)

Standard of care group

ACTIVE COMPARATOR

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

Expectant management group

NO INTERVENTION

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.

Interventions

Ringer's Acetate DRUG

Will receive a fluid bolus immediately (Ringer's Acetate 5 mls/kg bw) if oliguric/anuric for two consecutive hours

Also known as: Ringer Acetate

Standard of care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients going through pancreatic surgery.

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Central ICU (CIVA), Uppsal university hospital

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Postoperative Complications; Pancreatic Diseases; Edema

Interventions

Ringer's acetate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Diseases; Signs and Symptoms

Study Officials

• Miklos Lipcsey, MD, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 12, 2018
• Study Start: October 1, 2018
• Primary Completion: May 31, 2021
• Study Completion: August 30, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Locations

SE (1)