The Effects of Intensive Insulin on Somatic and Visceral Protein Turnover in Acute Kidney Injury (AKI)
Overview
- Phase
- Phase 2
- Intervention
- human regular insulin
- Conditions
- Acute Renal Failure
- Sponsor
- Vanderbilt University
- Primary Endpoint
- A change in whole body and muscle protein breakdown during amino acid supplementation with insulin versus baseline
- Status
- Withdrawn
- Last Updated
- 14 years ago
Overview
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.
Investigators
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
Arms & Interventions
1
Intervention: human regular insulin
Outcomes
Primary Outcomes
A change in whole body and muscle protein breakdown during amino acid supplementation with insulin versus baseline
Time Frame: 6 hours