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

Phase 2

Terminated

• Conditions: Acute Renal Failure
• Interventions: Drug: TPN nutritional supplement

• Registration Number: NCT00179166
• Lead Sponsor: Vanderbilt University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-23
• Last Update Posted: 2010-09-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	TPN nutritional supplement	supplement contains protein content of 2.0 g/kg/day
1	TPN nutritional supplement	supplement contains protein content of 1.4 g/kg/day

Primary Outcome Measures

Name	Time	Method
whole-body net protein balance	10 hours

Secondary Outcome Measures

Name	Time	Method
Net skeletal muscle protein balance	10 hours

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States