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

Primary Purpose

Acute Renal Failure

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TPN nutritional supplement
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Renal Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

supplement contains protein content of 1.4 g/kg/day

supplement contains protein content of 2.0 g/kg/day

Outcomes

Primary Outcome Measures

whole-body net protein balance

Secondary Outcome Measures

Net skeletal muscle protein balance

Full Information

First Posted
September 13, 2005
Last Updated
September 23, 2010
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT00179166
Brief Title
Assessment of Metabolic Response in Critically Ill Patients With Acute Renal Failure
Official Title
Assessment of Metabolic Response in Critically Ill Patients With Acute Renal Failure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Terminated
Why Stopped
lack of enrollment
Study Start Date
June 2004 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Renal Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
supplement contains protein content of 1.4 g/kg/day
Arm Title
2
Arm Type
Active Comparator
Arm Description
supplement contains protein content of 2.0 g/kg/day
Intervention Type
Drug
Intervention Name(s)
TPN nutritional supplement
Intervention Description
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%)
Primary Outcome Measure Information:
Title
whole-body net protein balance
Time Frame
10 hours
Secondary Outcome Measure Information:
Title
Net skeletal muscle protein balance
Time Frame
10 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alp Ikizler, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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

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