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

Phase 2TerminatedNCT00179166

Vanderbilt University3 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Renal Failure

Interventions

TPN nutritional supplementDRUG

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Vanderbilt University

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

whole-body net protein balance

Time frame: 10 hours

Secondary Outcomes

Net skeletal muscle protein balance

Time frame: 10 hours

Data from ClinicalTrials.gov

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