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

NCT ID: NCT00179166

Last Updated: 2010-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Acute Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

supplement contains protein content of 1.4 g/kg/day

Group Type ACTIVE_COMPARATOR

TPN nutritional supplement

Intervention Type DRUG

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

supplement contains protein content of 2.0 g/kg/day

Group Type ACTIVE_COMPARATOR

TPN nutritional supplement

Intervention Type DRUG

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%)

Interventions

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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%)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Vanderbilt University Medical Center

Principal Investigators

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Alp Ikizler, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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30941

Identifier Type: -

Identifier Source: org_study_id