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

Vanderbilt University logo

Vanderbilt University

Status and phase

Terminated
Phase 2

Conditions

Acute Renal Failure

Treatments

Drug: TPN nutritional supplement

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

3 participants in 2 patient groups

1
Active Comparator group
Description:
supplement contains protein content of 1.4 g/kg/day
Treatment:
Drug: TPN nutritional supplement
2
Active Comparator group
Description:
supplement contains protein content of 2.0 g/kg/day
Treatment:
Drug: TPN nutritional supplement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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