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

Acute Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00179166
• Other study ID #: 30941
• Status: Terminated
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: September 23, 2010
• Start date: June 2004
• Est. completion date: July 2005

Study information

• Verified date: September 2010
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Critical Illness
• Renal Insufficiency

Intervention

Drug:
• 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%)

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	whole-body net protein balance		10 hours	No
Secondary	Net skeletal muscle protein balance		10 hours	No