Uremic Toxins in the Intensive Care Unit (ICU): Patients With Sepsis
Primary Purpose
Renal Failure, Multi Organ Failure
Status
Withdrawn
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Dialysis during 4 hours
Dialysis during 6 hours
Dialysis during 8 hours
Sponsored by
About this trial
This is an interventional treatment trial for Renal Failure focused on measuring ICU patients with acute renal failure with sepsis/multi-organ failure
Eligibility Criteria
Inclusion Criteria:
- ICU patients with sepsis/multi-organ failure with acute renal failure
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Dialysis during 4 hours
Dialysis during 6 hours
Dialysis during 8 hours
Outcomes
Primary Outcome Measures
Registration of toxin removal efficiency
Secondary Outcome Measures
Full Information
NCT ID
NCT00752245
First Posted
September 12, 2008
Last Updated
December 14, 2022
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT00752245
Brief Title
Uremic Toxins in the Intensive Care Unit (ICU): Patients With Sepsis
Official Title
Study of the Kinetics of Uremic Toxins in the ICU Patients With Acute Renal Failure, in Order to Optimize the Dialysis Dose: Patients With Sepsis/Multi-organ Failure
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Study Start Date
July 31, 2008 (Actual)
Primary Completion Date
October 4, 2013 (Actual)
Study Completion Date
October 4, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study of the kinetics of uremic toxins in the ICU patients with acute renal failure, in order to optimize the dialysis dose: patients with sepsis/multi-organ failure. The sampling of blood and dialysate will be done during dialyses with different durations (4, 6 and 8h)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure, Multi Organ Failure
Keywords
ICU patients with acute renal failure with sepsis/multi-organ failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Dialysis during 4 hours
Arm Title
2
Arm Type
Active Comparator
Arm Description
Dialysis during 6 hours
Arm Title
3
Arm Type
Active Comparator
Arm Description
Dialysis during 8 hours
Intervention Type
Procedure
Intervention Name(s)
Dialysis during 4 hours
Intervention Description
Blood and dialysate sampling
Intervention Type
Procedure
Intervention Name(s)
Dialysis during 6 hours
Intervention Description
Blood and dialysate sampling
Intervention Type
Procedure
Intervention Name(s)
Dialysis during 8 hours
Intervention Description
Blood and dialysate sampling
Primary Outcome Measure Information:
Title
Registration of toxin removal efficiency
Time Frame
During dialysis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ICU patients with sepsis/multi-organ failure with acute renal failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Vanholder, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent
Learn more about this trial
Uremic Toxins in the Intensive Care Unit (ICU): Patients With Sepsis
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