Assessment of Metabolic Response in Critically Ill Patients With Acute Renal Failure - Full Text View

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00179166

Purpose

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).

Condition	Intervention	Phase
Acute Renal Failure	Drug: TPN nutritional supplement	Phase II

MedlinePlus related topics: Dietary Supplements Kidney Failure

Drug Information available for: Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title:	Assessment of Metabolic Response in Critically Ill Patients With Acute Renal Failure

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

whole-body net protein balance [ Time Frame: 10 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Net skeletal muscle protein balance [ Time Frame: 10 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	16
Study Start Date:	June 2004
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator supplement contains protein content of 1.4 g/kg/day	Drug: TPN nutritional supplement 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%)
2: Active Comparator supplement contains protein content of 2.0 g/kg/day	Drug: TPN nutritional supplement 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%)

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179166

Locations

United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

Alp Ikizler, MD

Vanderbilt University

More Information

Responsible Party:	Vanderbilt University Medical Center ( Alp Ikizler, MD )
Study ID Numbers:	30941
Study First Received:	September 13, 2005
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00179166
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Critical Illness
Renal Insufficiency, Acute

Kidney Diseases
Kidney Failure, Acute
Kidney Failure

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009