Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Fluid Therapy, Postoperative Period, Postoperative Complications, Pancreas Disease, Fluid Overload

Intervention / Treatment
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* Drug: Ringer's Acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care group<br>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<br>* Will receive a fluid bolus immediately (Ringer's Acetate 5 mls/kg bw) if oliguric/anuric for two consecutive hours<br>* Other names: Ringer Acetate;|
| No Intervention: Expectant management group<br>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?
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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 |