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Assessment of Metabolic Response in Critically Ill Patients With Acute Renal Failure

This study has been terminated.
(lack of enrollment)
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00179166
First received: September 13, 2005
Last updated: September 23, 2010
Last verified: September 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Metabolic Response in Critically Ill Patients With Acute Renal Failure

Resource links provided by NLM:


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 ]

Enrollment: 3
Study Start Date: June 2004
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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%)
Active Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Alp Ikizler, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00179166     History of Changes
Other Study ID Numbers: 30941
Study First Received: September 13, 2005
Last Updated: September 23, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acute Kidney Injury
Critical Illness
Renal Insufficiency
Disease Attributes
Kidney Diseases
Pathologic Processes
Urologic Diseases

ClinicalTrials.gov processed this record on November 19, 2014