Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03553394
• Other study ID #: 2018/147
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: August 30, 2022

Study information

• Verified date: October 2022
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: August 30, 2022
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fluid Overload
• Fluid Therapy
• Pancreas Disease
• Pancreatic Diseases
• Postoperative Complications
• Postoperative Period

Intervention

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

Locations

Country	Name	City	State
Sweden	Central ICU (CIVA), Uppsal university hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

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