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

Acute Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00592410
• Other study ID #: 061022
• Status: Withdrawn
• Phase: Phase 2
• First received: December 18, 2007
• Last updated: August 4, 2011
• Start date: February 2007
• Est. completion date: November 2008

Study information

• Verified date: August 2011
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A change in whole body and muscle protein breakdown during amino acid supplementation with insulin versus baseline		6 hours	No