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

Vanderbilt University1 site in 1 country3 target enrollmentJune 2004

ConditionsAcute Renal Failure

InterventionsTPN nutritional supplement

DrugsTPN nutritional supplement

Overview

Phase: Phase 2
Intervention: TPN nutritional supplement
Conditions: Acute Renal Failure
Sponsor: Vanderbilt University
Enrollment: 3
Locations: 1
Primary Endpoint: whole-body net protein balance
Status: Terminated
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

June 2004

End Date

July 2005

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vanderbilt University

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