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

18 dicembre 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

338

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30326
        • Emory University Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Intensive insulin treatment
Intensive insulin treatment (BG target: 100-140 mg/dL)
Altro: Regular insulin (intensive treatment)
Titration of the IV insulin rate for glucose goal 100-140 mg/dL
Comparatore attivo: Conventional insulin treatment
Conventional insulin treatment (BG target: 141-180 mg/dl)
Altro: Regular Insulin (conventional treatment)
Titration of the IV insulin rate for glucose goal 141-180 mg/dl

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Subjects That Were Diagnosed for Peri-operative Complications
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Glycemic Control
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: average 1 month during the hospitalization
ICU and hospital length of stay, and ICU readmissions
average 1 month during the hospitalization
Surgical Wound Infection
Lasso di tempo: average 1 month during the hospitalization
superficial and deep sternal wound infection
average 1 month during the hospitalization
Pneumonia (CDC Criteria)
Lasso di tempo: average 1 month during the hospitalization
Pneumonia (CDC criteria)
average 1 month during the hospitalization
Cerebrovascular Events
Lasso di tempo: 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
Lasso di tempo: average 1 month during the hospitalization
Duration of ventilatory support and ICU readmission
average 1 month during the hospitalization
Thirty Day Mortality
Lasso di tempo: within 30 days of discharge
Thirty day mortality
within 30 days of discharge
Number of Hospital Readmissions and Emergency Room Visits
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: within 3 months after discharge
Superficial and deep sternal wound infection
within 3 months after discharge
Pneumonia (CDC Criteria)
Lasso di tempo: Within 3 months after discharge
Pneumonia (CDC criteria)
Within 3 months after discharge
Cerebrovascular Events
Lasso di tempo: within 3 months after discharge
permanent stroke and reversible ischemic neurologic deficit
within 3 months after discharge

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Emory University

Collaboratori

American Diabetes Association

Investigatori

  • Investigatore principale: Guillermo E Umpierrez, MD, Emory University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2011

Completamento primario (Effettivo)

1 dicembre 2013

Completamento dello studio (Effettivo)

1 dicembre 2013

Date di iscrizione allo studio

Primo inviato

3 febbraio 2011

Primo inviato che soddisfa i criteri di controllo qualità

26 maggio 2011

Primo Inserito (Stima)

27 maggio 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

31 dicembre 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 dicembre 2014

Ultimo verificato

1 dicembre 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRB00048356
  • 00048356-2010 (Altro identificatore: Other)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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