Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients

NCT ID: NCT03553394

Last Updated: 2022-10-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2022-08-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Ringer's Acetate

Intervention Type: DRUG

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ringer's Acetate

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

Intervention Type: DRUG

Other Intervention Names

Ringer Acetate

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miklos Lipcsey, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Central ICU (CIVA), Uppsal university hospital

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

2018/147

Identifier Type: -

Identifier Source: org_study_id