- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01361594
Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery (CABG)
18 de dezembro de 2014 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
338
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Georgia
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Atlanta, Georgia, Estados Unidos, 30326
- Emory University Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: Intensive insulin treatment
Intensive insulin treatment (BG target: 100-140 mg/dL)
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Titration of the IV insulin rate for glucose goal 100-140 mg/dL
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Comparador Ativo: Conventional insulin treatment
Conventional insulin treatment (BG target: 141-180 mg/dl)
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Titration of the IV insulin rate for glucose goal 141-180 mg/dl
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Number of Subjects That Were Diagnosed for Peri-operative Complications
Prazo: 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
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Within 6 months of hospitalization
|
Hospital Mortality
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Glycemic Control
Prazo: average 1 month during the hospitalization
|
|
average 1 month during the hospitalization
|
Major Cardiovascular Events
Prazo: average 1 month during the hospitalization
|
|
average 1 month during the hospitalization
|
Acute Renal Failure
Prazo: 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.
Prazo: 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
Prazo: average 1 month during the hospitalization
|
ICU and hospital length of stay, and ICU readmissions
|
average 1 month during the hospitalization
|
Surgical Wound Infection
Prazo: average 1 month during the hospitalization
|
superficial and deep sternal wound infection
|
average 1 month during the hospitalization
|
Pneumonia (CDC Criteria)
Prazo: average 1 month during the hospitalization
|
Pneumonia (CDC criteria)
|
average 1 month during the hospitalization
|
Cerebrovascular Events
Prazo: 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
Prazo: average 1 month during the hospitalization
|
Duration of ventilatory support and ICU readmission
|
average 1 month during the hospitalization
|
Thirty Day Mortality
Prazo: within 30 days of discharge
|
Thirty day mortality
|
within 30 days of discharge
|
Number of Hospital Readmissions and Emergency Room Visits
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: within 3 months after discharge
|
|
within 3 months after discharge
|
Surgical Wound Infection
Prazo: within 3 months after discharge
|
Superficial and deep sternal wound infection
|
within 3 months after discharge
|
Pneumonia (CDC Criteria)
Prazo: Within 3 months after discharge
|
Pneumonia (CDC criteria)
|
Within 3 months after discharge
|
Cerebrovascular Events
Prazo: within 3 months after discharge
|
permanent stroke and reversible ischemic neurologic deficit
|
within 3 months after discharge
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Guillermo E Umpierrez, MD, Emory University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de junho de 2011
Conclusão Primária (Real)
1 de dezembro de 2013
Conclusão do estudo (Real)
1 de dezembro de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
3 de fevereiro de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de maio de 2011
Primeira postagem (Estimativa)
27 de maio de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
31 de dezembro de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de dezembro de 2014
Última verificação
1 de dezembro de 2014
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB00048356
- 00048356-2010 (Outro identificador: Other)
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