|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2022 |
|
Main ID: |
NCT03553394 |
|
Date of registration:
|
23/05/2018 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients
|
|
Scientific title:
|
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 |
|
Date of first enrolment:
|
October 1, 2018 |
|
Target sample size:
|
53 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT03553394 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Sweden
| | | | | | | |
|
Contacts
|
|
Name:
|
Miklos Lipcsey, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Uppsala University |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Postoperative Complications
|
|
Postoperative Period
|
|
Fluid Overload
|
|
Fluid Therapy
|
|
Pancreas Disease
|
|
Intervention(s)
|
|
Drug: Ringer's Acetate
|
|
Primary Outcome(s)
|
|
Urinary output
[Time Frame: 2 hours]
|
|
Secondary Outcome(s)
|
|
Postoperative complications
[Time Frame: 90 days]
|
|
Renal replacement therapy
[Time Frame: Up to 90 days]
|
|
Cumulative fluid balance
[Time Frame: 48 hours]
|
|
Renal function
[Time Frame: 48 hours]
|
|
Inotropy
[Time Frame: 1 week]
|
|
Mortality
[Time Frame: 90 days]
|
|
S-osmolality
[Time Frame: 1 day]
|
|
Vasopressin (ADH)
[Time Frame: 1 day]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|