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Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553394
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Uppsala University

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
Fluid Therapy Postoperative Period Postoperative Complications Pancreas Disease Fluid Overload Drug: Ringer's Acetate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

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 Name: Ringer Acetate

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.



Primary Outcome Measures :
  1. Urinary output [ Time Frame: 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 :
  1. Renal function [ Time Frame: 48 hours ]
    Renal function after 48 hours

  2. Cumulative fluid balance [ Time Frame: 48 hours ]
    Difference in cumulative fluid balance

  3. Postoperative complications [ Time Frame: 90 days ]
    Frequency of postoperative complications in both groups

  4. Renal replacement therapy [ Time Frame: Up to 90 days ]
    The need for renal replacement therapy during the hospital stay

  5. Mortality [ Time Frame: 90 days ]
    90-day mortality in both groups

  6. Inotropy [ Time Frame: 1 week ]
    Postoperative need of inotropic therapy during the stay in the postoperative department

  7. Vasopressin (ADH) [ Time Frame: 1 day ]
    Levels of vasopressin in serum immediately before and after the operation

  8. S-osmolality [ Time Frame: 1 day ]
    S-osmolality immediately before and after the operation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553394


Contacts
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Contact: Miklos Lipcsey, MD, PhD +46186110000 miklos.lipcsey@surgsci.uu.se
Contact: Sandra Horst, MD +46739854055 sandra.horst@akademiska.se

Locations
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Sweden
Central ICU (CIVA), Uppsal university hospital Recruiting
Uppsala, Sweden, 75185
Contact: Rafael Kawati, MD, PhD    46186110000    rafael.kawati@akademiska.se   
Contact: Sandra Horst, PhD-stud    46739854055    sandra.horst@akademiska.se   
Principal Investigator: Miklos Lipcsey, MD, PhD         
Sponsors and Collaborators
Uppsala University
Investigators
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Principal Investigator: Miklos Lipcsey, MD, PhD Uppsala University

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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT03553394    
Other Study ID Numbers: 2018/147
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Diseases
Postoperative Complications
Pathologic Processes
Digestive System Diseases