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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03553394
Other study ID # 2018/147
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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