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

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00752245
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 3
• Duration (Months): 87
• Patients Per Site Per Month: 0.1

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Renal Failure; Multi Organ Failure	Procedure: Dialysis during 4 hours; Procedure: Dialysis during 6 hours; Procedure: Dialysis during 8 hours	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (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
• Study Start Date: Sep 1, 2008
• Anticipated Primary Completion Date: Dec 1, 2015
• Anticipated Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Registration of toxin removal efficiency [During dialysis]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ICU patients with sepsis/multi-organ failure with acute renal failure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ghent	Ghent		Belgium	9000

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

• Principal Investigator: Raymond Vanholder, MD, PhD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Website of the University Hospital Ghent

Publications

None provided.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT00752245
• Other Study ID Numbers: 2008/373
• First Posted: Sep 15, 2008
• Last Update Posted: Jun 3, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by University Hospital, Ghent: ICU patients with acute renal failure with sepsis/multi-organ failure
• Additional relevant MeSH terms: Sepsis; Renal Insufficiency; Multiple Organ Failure

Study Results

No Results Posted as of Jun 3, 2015