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Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery (CABG)

18. desember 2014 oppdatert av: Guillermo Umpierrez, Emory University
High blood glucose levels (hyperglycemia) in cardiac surgery patients with diabetes are associated with increased risk of hospital complications. Blood sugar control with intravenous insulin may prevent such hospital complications. Many patients undergoing cardiac bypass surgery (CABG) develop high blood sugars and require insulin therapy (shortly before or after surgery). It is not clear what the best insulin regimen is or what is the best blood sugar target in these patients. Accordingly, this research study aims to determine optimal blood glucose levels during the in patients undergoing cardiac bypass surgery. Patients will be divided in two groups. The intensive insulin group will be maintained at blood glucose between 100-140 mg/dl and the conventional treatment group at a glucose level between 140-180 mg/dl. The insulins to be used in this trial (lantus, aspart and regular insulin) are approved for use in the treatment of patients with diabetes by the FDA (Food and Drug Administration). A total of 326 patients with high blood glucose after cardiac bypass surgery will be recruited in this study. Patients will be recruited at Emory University Hospital, Emory Midtown Hospital and Grady Memorial Hospital.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Several prospective cohort studies as well as randomized clinical trials (RCT) in cardiac surgery patients have shown that intensified insulin therapy (target BG: 110-140 mg/dl) results in a reduction in short- and long-term mortality compared with conventionally treated patients. The results of recent international trials in critically ill patients; however, have failed to show a significant improvement in mortality or have even shown increased mortality risk as well as increased number of hypoglycemic events with intensive compared to less intensive glycemic control. Based on the results of these ICU trials, new ADA and AACE guidelines recommended a glycemic target between 140 and 180 mg/dl in the ICU including cardiac surgery patients. There is concern that such high BG targets might increase the risk of hospital complications in cardiac surgical patients in whom intensive glucose control has consistently reduced infections, length of hospital stay, resource utilization, and cardiac-related mortality. The overall objective of this proposal is to conduct the first prospective RCT to determine the optimal BG target during the perioperative period in hyperglycemic subjects who undergo CABG in the United States. Subjects will be randomized to undergo intensive insulin therapy adjusted to maintain a BG between 100 mg/dl and 140 mg/dl or to a conventional glucose control with a target BG between 141 mg/dl and 200 mg/dl in the ICU. The central hypothesis of this proposal is that intensive insulin management will reduce perioperative complications compared to a conventional BG control in cardiac surgery patients.

Studietype

Intervensjonell

Registrering (Faktiske)

338

Fase

  • Fase 3

Kontakter og plasseringer

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Studiesteder

  • Forente stater
    • Georgia
      • Atlanta, Georgia, Forente stater, 30326
        • Emory University Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Males or females between the ages of 18 and 80 years undergoing CABG +/- valve surgery.
  2. Post surgical hyperglycemia (BG > 140 mg/dl).
  3. Patients with and without a history of type 2 diabetes

Exclusion Criteria:

  1. Patients requiring combination CABG with additional procedures such aorta replacement.
  2. Patients with severely impaired renal function (serum creatinine ≥3.0 mg/dl or GFR < 30 ml/min) or clinically significant hepatic failure.
  3. Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.
  4. Moribund patients and those at imminent risk of death (brain death or cardiac standstill).
  5. Patients or next-to-kin with mental condition rendering the subject or family member unable to understand the nature, scope, and possible consequences of the study.
  6. Female subjects who are pregnant or breast-feeding at time of enrollment into the study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Intensive insulin treatment
Intensive insulin treatment (BG target: 100-140 mg/dL)
Annen: Regular insulin (intensive treatment)
Titration of the IV insulin rate for glucose goal 100-140 mg/dL
Aktiv komparator: Conventional insulin treatment
Conventional insulin treatment (BG target: 141-180 mg/dl)
Annen: Regular Insulin (conventional treatment)
Titration of the IV insulin rate for glucose goal 141-180 mg/dl

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Subjects That Were Diagnosed for Peri-operative Complications
Tidsramme: Within 6 months of hospitalization
Number of participants that presented at least 1 complications including sternal wound infection, bacteremia, acute renal failure, respiratory failure, and major cardiovascular events (MACE) during the current hospitalization and up to 6 months after hospitalization
Within 6 months of hospitalization
Hospital Mortality
Tidsramme: average 1 month during the hospitalization
Mortality is defined as death occurring during admission, either during ICU or after transition to non-ICU admission.
average 1 month during the hospitalization

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Glycemic Control
Tidsramme: average 1 month during the hospitalization
  1. Hyperglycemic events (BG > 200 mg/dL) in ICU and non-ICU
  2. Hypoglycemic events (BG < 70 mg/dl; severe hypoglycemia (BG < 40 mg/dl).
average 1 month during the hospitalization
Major Cardiovascular Events
Tidsramme: average 1 month during the hospitalization
  1. Acute myocardial infarction : (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischemic symptoms, (b) development of pathologic Q waves on the electrocardiogram, (c) electrocardiographic changes indicative of ischemia (ST-segment elevation or depression), or (d) coronary artery intervention (e.g., coronary angioplasty).
  2. Congestive heart failure
  3. Cardiac arrhythmias: malignant arrhythmia
average 1 month during the hospitalization
Acute Renal Failure
Tidsramme: average 1 month during the hospitalization
new-onset abnormal renal function: serum creatinine > 2.0 mg/dL or an increment level > 50% from baseline
average 1 month during the hospitalization
Respiratory Failure, Defined as PaO2 Value < 60 mm Hg While Breathing Air or a PaCO2 > 50 mm Hg.
Tidsramme: average 1 month during the hospitalization
Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg.
average 1 month during the hospitalization
ICU and Hospital Length of Stay, and ICU Readmissions
Tidsramme: average 1 month during the hospitalization
ICU and hospital length of stay, and ICU readmissions
average 1 month during the hospitalization
Surgical Wound Infection
Tidsramme: average 1 month during the hospitalization
superficial and deep sternal wound infection
average 1 month during the hospitalization
Pneumonia (CDC Criteria)
Tidsramme: average 1 month during the hospitalization
Pneumonia (CDC criteria)
average 1 month during the hospitalization
Cerebrovascular Events
Tidsramme: average 1 month during the hospitalization
permanent stroke and reversible ischemic neurologic deficit.
average 1 month during the hospitalization
Duration of Ventilatory Support and ICU Readmission
Tidsramme: average 1 month during the hospitalization
Duration of ventilatory support and ICU readmission
average 1 month during the hospitalization
Thirty Day Mortality
Tidsramme: within 30 days of discharge
Thirty day mortality
within 30 days of discharge
Number of Hospital Readmissions and Emergency Room Visits
Tidsramme: Within 30 days after discharge
Number of hospital readmissions and emergency room visits
Within 30 days after discharge
Incidence of Organ Failures Assessed by the Daily SOFA Score
Tidsramme: average 1 month during the hospitalization
Incidence of organ failures assessed by the daily SOFA score
average 1 month during the hospitalization
Measures of Inflammation
Tidsramme: average 1 month during the hospitalization
Measures of inflammation (C-reactive protein, TNF-alpha; IL-6) and oxidative stress markers
average 1 month during the hospitalization
Major Cardiovascular Events
Tidsramme: within 3 months after discharge
  1. Acute myocardial infarction : (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischemic symptoms, (b) development of pathologic Q waves on the electrocardiogram, (c) electrocardiographic changes indicative of ischemia (ST-segment elevation or depression), or (d) coronary artery intervention (e.g., coronary angioplasty).
  2. Congestive heart failure
  3. Cardiac arrhythmias: malignant arrhythmia
within 3 months after discharge
Surgical Wound Infection
Tidsramme: within 3 months after discharge
Superficial and deep sternal wound infection
within 3 months after discharge
Pneumonia (CDC Criteria)
Tidsramme: Within 3 months after discharge
Pneumonia (CDC criteria)
Within 3 months after discharge
Cerebrovascular Events
Tidsramme: within 3 months after discharge
permanent stroke and reversible ischemic neurologic deficit
within 3 months after discharge

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Emory University

Samarbeidspartnere

American Diabetes Association

Etterforskere

  • Hovedetterforsker: Guillermo E Umpierrez, MD, Emory University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2011

Primær fullføring (Faktiske)

1. desember 2013

Studiet fullført (Faktiske)

1. desember 2013

Datoer for studieregistrering

Først innsendt

3. februar 2011

Først innsendt som oppfylte QC-kriteriene

26. mai 2011

Først lagt ut (Anslag)

27. mai 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

31. desember 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. desember 2014

Sist bekreftet

1. desember 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB00048356
  • 00048356-2010 (Annen identifikator: Other)

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