- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00179166
Assessment of Metabolic Response in Critically Ill Patients With Acute Renal Failure
September 23, 2010 updated by: Vanderbilt University
We hypothesize that a nutritional supplementation with higher than standard protein content (2.0 gm/Kg/day vs 1.4 gm/Kg/day) will result in improved whole-body net protein balance when administered to critically ill patients with acute renal failure (ARF).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults ≥ 18 years of age admitted to the intensive care unit
- New onset acute renal failure (ARF) or ARF superimposed on chronic kidney disease
- ARF will be defined by a sustained (over 24 hours) increase in serum creatinine > 0.5 mg/dl from baseline
- Patients will be recruited for the study within 3-5 days following establishment of ARF
Exclusion Criteria:
- Institutionalized patient
- Previous kidney transplant
- Pregnancy
- Unable to obtain consent from subject or legally recognized representative
- ARF from urinary tract obstruction or a volume responsive pre-renal state.
- Liver Failure
- Recent cerebrovascular accident (CVA)
- Coagulopathy defined as: Platelets < 50, PT > 20, INR > 2.0 if the patient requires the placement of an arterial or venous catheter; if the patient does not require the placement of an arterial or venous catheter for the study, coagulopathy will not be a basis for exclusion.
- Life expectancy < 48 hours
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
supplement contains protein content of 1.4 g/kg/day
|
intravenous administration of nutritional supplement for 4 hours at a dosage of 30 kcal/kg/day, in the form of lipids, carbohydrates and protein; the non-protein calories are comprised of lipids (30%) and carbohydrates (70%)
|
Active Comparator: 2
supplement contains protein content of 2.0 g/kg/day
|
intravenous administration of nutritional supplement for 4 hours at a dosage of 30 kcal/kg/day, in the form of lipids, carbohydrates and protein; the non-protein calories are comprised of lipids (30%) and carbohydrates (70%)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
whole-body net protein balance
Time Frame: 10 hours
|
10 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Net skeletal muscle protein balance
Time Frame: 10 hours
|
10 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alp Ikizler, MD, Vanderbilt University Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Primary Completion (Actual)
July 1, 2005
Study Completion (Actual)
July 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
September 27, 2010
Last Update Submitted That Met QC Criteria
September 23, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30941
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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