Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients

Uppsala University

Status: Terminated

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

Treatments: Drug: Ringer's Acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT03553394

2018/147

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

Standard of care group

Active Comparator group

Description:

Will receive a fluid bolus 5 ml/kg Ringer's Acetate infusion immediately if oliguric/anuric for two consecutive hours (standard of care).

Treatment:

Drug: Ringer's Acetate

Expectant management group

No Intervention group

Description:

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.