Skip to content

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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00179166
Enrollment
3
Registered
2005-09-15
Start date
2004-06-30
Completion date
2005-07-31
Last updated
2010-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Failure

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).

Interventions

DRUGTPN 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%)

Sponsors

Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
whole-body net protein balance10 hours

Secondary

MeasureTime frame
Net skeletal muscle protein balance10 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026