Fluid Overload, Fluid Therapy, Pancreas Disease, Postoperative Complications, Postoperative Period
Conditions
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.
Interventions
DRUGRinger's Acetate
Will receive a fluid bolus immediately (Ringer's Acetate 5 mls/kg bw) if oliguric/anuric for two consecutive hours
Sponsors
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Renal function | 48 hours | Renal function after 48 hours |
| 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 |
| Mortality | 90 days | 90-day mortality in both groups |
Countries
Sweden
Outcome results
None listed