- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01361594
Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery (CABG)
18 de diciembre de 2014 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
338
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Georgia
-
Atlanta, Georgia, Estados Unidos, 30326
- Emory University Hospital
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Males or females between the ages of 18 and 80 years undergoing CABG +/- valve surgery.
- Post surgical hyperglycemia (BG > 140 mg/dl).
- Patients with and without a history of type 2 diabetes
Exclusion Criteria:
- Patients requiring combination CABG with additional procedures such aorta replacement.
- Patients with severely impaired renal function (serum creatinine ≥3.0 mg/dl or GFR < 30 ml/min) or clinically significant hepatic failure.
- Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.
- Moribund patients and those at imminent risk of death (brain death or cardiac standstill).
- 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.
- Female subjects who are pregnant or breast-feeding at time of enrollment into the study.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Intensive insulin treatment
Intensive insulin treatment (BG target: 100-140 mg/dL)
|
Titration of the IV insulin rate for glucose goal 100-140 mg/dL
|
|
Comparador activo: Conventional insulin treatment
Conventional insulin treatment (BG target: 141-180 mg/dl)
|
Titration of the IV insulin rate for glucose goal 141-180 mg/dl
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Subjects That Were Diagnosed for Peri-operative Complications
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Glycemic Control
Periodo de tiempo: average 1 month during the hospitalization
|
|
average 1 month during the hospitalization
|
|
Major Cardiovascular Events
Periodo de tiempo: average 1 month during the hospitalization
|
|
average 1 month during the hospitalization
|
|
Acute Renal Failure
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: average 1 month during the hospitalization
|
ICU and hospital length of stay, and ICU readmissions
|
average 1 month during the hospitalization
|
|
Surgical Wound Infection
Periodo de tiempo: average 1 month during the hospitalization
|
superficial and deep sternal wound infection
|
average 1 month during the hospitalization
|
|
Pneumonia (CDC Criteria)
Periodo de tiempo: average 1 month during the hospitalization
|
Pneumonia (CDC criteria)
|
average 1 month during the hospitalization
|
|
Cerebrovascular Events
Periodo de tiempo: 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
Periodo de tiempo: average 1 month during the hospitalization
|
Duration of ventilatory support and ICU readmission
|
average 1 month during the hospitalization
|
|
Thirty Day Mortality
Periodo de tiempo: within 30 days of discharge
|
Thirty day mortality
|
within 30 days of discharge
|
|
Number of Hospital Readmissions and Emergency Room Visits
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: within 3 months after discharge
|
|
within 3 months after discharge
|
|
Surgical Wound Infection
Periodo de tiempo: within 3 months after discharge
|
Superficial and deep sternal wound infection
|
within 3 months after discharge
|
|
Pneumonia (CDC Criteria)
Periodo de tiempo: Within 3 months after discharge
|
Pneumonia (CDC criteria)
|
Within 3 months after discharge
|
|
Cerebrovascular Events
Periodo de tiempo: within 3 months after discharge
|
permanent stroke and reversible ischemic neurologic deficit
|
within 3 months after discharge
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Guillermo E Umpierrez, MD, Emory University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2011
Finalización primaria (Actual)
1 de diciembre de 2013
Finalización del estudio (Actual)
1 de diciembre de 2013
Fechas de registro del estudio
Enviado por primera vez
3 de febrero de 2011
Primero enviado que cumplió con los criterios de control de calidad
26 de mayo de 2011
Publicado por primera vez (Estimar)
27 de mayo de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
31 de diciembre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
18 de diciembre de 2014
Última verificación
1 de diciembre de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00048356
- 00048356-2010 (Otro identificador: Other)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .