The Effects of Intensive Insulin on Somatic and Visceral Protein Turnover in Acute Kidney Injury (AKI)
4. august 2011 opdateret af: Vanderbilt University
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.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Fase
- Fase 2
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 1
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
A change in whole body and muscle protein breakdown during amino acid supplementation with insulin versus baseline
Tidsramme: 6 hours
|
6 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Alp Ikizler, MD, Vanderbilt University Medical Center
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2007
Primær færdiggørelse (Faktiske)
1. november 2008
Studieafslutning (Faktiske)
1. november 2008
Datoer for studieregistrering
Først indsendt
18. december 2007
Først indsendt, der opfyldte QC-kriterier
1. januar 2008
Først opslået (Skøn)
14. januar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. august 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. august 2011
Sidst verificeret
1. august 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 061022
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