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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Withdrawn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
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 12, 2008
Last Updated
December 14, 2022
Sponsor
University Hospital, Ghent
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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Withdrawn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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