Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Standard of care group 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
Will receive a fluid bolus immediately (Ringer's Acetate 5 mls/kg bw) if oliguric/anuric for two consecutive hours
Other Names:
|
| No Intervention: Expectant management group 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. |
Outcome Measures
Primary Outcome Measures
- Urinary output [2 hours]
Difference in urinary output two hours after giving the patient a fluid bolus (Control Group) or awaiting fluid bolus (interventional Group)..
Secondary Outcome Measures
- Renal function [48 hours]
Renal function after 48 hours
- Cumulative fluid balance [48 hours]
Difference in cumulative fluid balance
- Postoperative complications [90 days]
Frequency of postoperative complications in both groups
- Renal replacement therapy [Up to 90 days]
The need for renal replacement therapy during the hospital stay
- Mortality [90 days]
90-day mortality in both groups
- Inotropy [1 week]
Postoperative need of inotropic therapy during the stay in the postoperative department
- Vasopressin (ADH) [1 day]
Levels of vasopressin in serum immediately before and after the operation
- S-osmolality [1 day]
S-osmolality immediately before and after the operation
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Central ICU (CIVA), Uppsal university hospital | Uppsala | Sweden | 75185 |
Sponsors and Collaborators
- Uppsala University
Investigators
- Principal Investigator: Miklos Lipcsey, MD, PhD, Uppsala University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018/147