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Uremic Toxins in the Intensive Care Unit (ICU): Patients With Sepsis

This study is currently recruiting participants.
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00752245
First received: September 12, 2008
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose

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)


Condition Intervention
Renal Failure
Multi Organ Failure
 Procedure: Dialysis during 4 hours
Procedure: Dialysis during 6 hours
Procedure: Dialysis during 8 hours

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Sepsis
U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Registration of toxin removal efficiency [ Time Frame: During dialysis ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: September 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dialysis during 4 hours
 Procedure: Dialysis during 4 hours
Blood and dialysate sampling
Active Comparator: 2
Dialysis during 6 hours
 Procedure: Dialysis during 6 hours
Blood and dialysate sampling
Active Comparator: 3
Dialysis during 8 hours
 Procedure: Dialysis during 8 hours
Blood and dialysate sampling

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ICU patients with sepsis/multi-organ failure with acute renal failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752245

Contacts
Contact: Sunny Eloot, PhD Sunny.eloot@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Principal Investigator: Raymond Vanholder, MD, PhD            
Sub-Investigator: Sunny Eloot, PhD            
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Raymond Vanholder, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00752245     History of Changes
Other Study ID Numbers: 2008/373
Study First Received: September 12, 2008
Last Updated: February 1, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
ICU patients with acute renal failure with sepsis/multi-organ failure

Additional relevant MeSH terms:
Acute Kidney Injury
Multiple Organ Failure
Renal Insufficiency
Sepsis
Kidney Diseases
Urologic Diseases
 Shock
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on May 19, 2013