Clinical trial NCT00592410: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acute Renal Failure
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2008-01-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: A change in whole body and muscle protein breakdown during amino acid supplementation with insulin versus baseline
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University Medical Center
name: Alp Ikizler, MD
role: PRINCIPAL_INVESTIGATOR
References: