Clinical trial NCT03553394: Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fluid Therapy
Postoperative Period
Postoperative Complications
Pancreas Disease
Fluid Overload
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Urinary output
timeFrame: 2 hours
Secondary outcomes:
measure: Renal function
timeFrame: 48 hours
measure: Cumulative fluid balance
timeFrame: 48 hours
measure: Postoperative complications
timeFrame: 90 days
measure: Renal replacement therapy
timeFrame: Up to 90 days
measure: Mortality
timeFrame: 90 days
measure: Inotropy
timeFrame: 1 week
measure: Vasopressin (ADH)
timeFrame: 1 day
measure: S-osmolality
timeFrame: 1 day
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Central ICU (CIVA), Uppsal university hospital
Study officials:
affiliation: Uppsala University
name: Miklos Lipcsey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: