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

Primary Purpose

Acute Renal Failure

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
human regular insulin
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Renal Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Outcomes

    Primary Outcome Measures

    A change in whole body and muscle protein breakdown during amino acid supplementation with insulin versus baseline

    Secondary Outcome Measures

    Full Information

    First Posted
    December 18, 2007
    Last Updated
    August 4, 2011
    Sponsor
    Vanderbilt University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00592410
    Brief Title
    The Effects of Intensive Insulin on Somatic and Visceral Protein Turnover in Acute Kidney Injury (AKI)
    Official Title
    The Effects of Intensive Insulin on Somatic and Visceral Protein Turnover in Acute Kidney Injury (AKI)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2011
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    no enrollment
    Study Start Date
    February 2007 (undefined)
    Primary Completion Date
    November 2008 (Actual)
    Study Completion Date
    November 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Vanderbilt University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Renal Failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    human regular insulin
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    A change in whole body and muscle protein breakdown during amino acid supplementation with insulin versus baseline
    Time Frame
    6 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alp Ikizler, MD
    Organizational Affiliation
    Vanderbilt University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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