NCT00179166

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

September 27, 2010

Status Verified

September 1, 2010

Enrollment Period

1.1 years

First QC Date

September 13, 2005

Last Update Submit

September 23, 2010

Conditions

Acute Renal Failure

Outcome Measures

Primary Outcomes (1)

  • whole-body net protein balance

    10 hours

Secondary Outcomes (1)

  • Net skeletal muscle protein balance

    10 hours

Study Arms (2)

1

ACTIVE COMPARATOR

supplement contains protein content of 1.4 g/kg/day

Drug: TPN nutritional supplement

2

ACTIVE COMPARATOR

supplement contains protein content of 2.0 g/kg/day

Drug: TPN nutritional supplement

Interventions

TPN nutritional supplementDRUG

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%)

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Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • Life expectancy \< 48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Alp Ikizler, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

June 1, 2004

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

September 27, 2010

Record last verified: 2010-09

Locations

US(1)