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The Effects of Intensive Insulin on Somatic and Visceral Protein Turnover in Acute Kidney Injury (AKI)

This study has been withdrawn prior to enrollment.
(no enrollment)
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00592410
First received: December 18, 2007
Last updated: August 4, 2011
Last verified: August 2011
History of Changes
  Purpose

We propose to determine the acute metabolic effects of intensive insulin therapy when administered to AKI patients with a particular focus on its effects on protein metabolism. We hypothesize that the degree of insulin resistance correlates with protein catabolism in critically ill patients with AKI, and that intensive insulin therapy will result in substantial reductions in both whole-body and skeletal muscle protein breakdown thereby improving overall protein balance. We also hypothesize that this therapy will have favorable effects on the inflammatory and oxidative stress profile of patients with AKI. The metabolic response to these interventions will be assessed through stable isotope infusion techniques, allowing for the most precise assessment of protein and energy homeostasis.


Condition Intervention Phase
Acute Renal Failure
 Drug: human regular insulin
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Intensive Insulin on Somatic and Visceral Protein Turnover in Acute Kidney Injury (AKI)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • A change in whole body and muscle protein breakdown during amino acid supplementation with insulin versus baseline [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: human regular insulin
administration of a primed continuous infusion of human regular insulin at a rate of 2.0 mU/kg/min while maintaining the plasma glucose level at 100 mg/dl via adjusting a variable infusion of 50% dextrose (i.e., a hyperinsulinemic euglycemic blood glucose clamp); duration of 3 hours; performed concomitantly with amino acid supplementation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults ≥ 18 years of age admitted to the intensive care unit

  • New onset acute kidney injury (AKI) or AKI superimposed on chronic kidney disease. AKI will be defined as:

    • an abrupt (within 48 hours) sustained increase (>24 hours) in serum creatinine of 2X baseline or
    • a reduction in urine output (documented oliguria of < 0.5 ml/kg/hr for >12 hours)
  • Patients will be recruited for the study within 3-5 days following establishment of AKI

Exclusion Criteria:

  • Institutionalized patient
  • Unable to obtain consent from subject or legally recognized representative
  • Pregnancy
  • Patients receiving insulin within 12 hours of the study or patients with known diabetes mellitus.
  • Patients receiving immunosuppressive medication including steroids (prednisone or equivalent dose ≥ 5 mg PO QD)
  • AKI from urinary tract obstruction or a volume responsive pre-renal state.
  • Liver Failure, defined as transaminase levels 3 times above the limit of normal or a total Bilirubin greater than 4 mg/dl.
  • Evidence of active bleeding, defined as admission for bleeding (ex. GI bleed, ruptured aneurysm, trauma-related) coupled with an explained or unexplained decrease in hemoglobin of >2 points in the past 24 hours, or Hgb<8/Hct<24
  • Ongoing myocardial ischemia or heart failure
  • Life expectancy < 48 hours
  • Patients without existing central venous access
  • Hemodynamically unstable patients requiring active pressor titration, defined as an increase in current pressor dose by >20% or addition of a new pressor within 12 hours of initiating the study.
  • History of Phenylketonuria (PKU) or other documented inborn errors of metabolism
  • Hypokalemia, defined as a serum potassium of <3.0 mg/dl.
  • Uncontrolled seizure disorder, defined as having seizure as a reason for admission, ongoing delirium tremens, or having had a seizure within 1 month of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592410

Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Alp Ikizler, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Alp Ikizler, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00592410     History of Changes
Other Study ID Numbers: 061022
Study First Received: December 18, 2007
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013