Estudo randomizado, aberto, para avaliação da eficácia e segurança de dois protocolos para infusão de insulina endovenosa e um protocolo de administração de insulina subcutânea, em pacientes gravemente enfermos

Cavalcanti, Alexandre Biasi

doi:10.11606/T.5.2008.tde-19112008-161404

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Doctoral Thesis

DOI

https://doi.org/10.11606/T.5.2008.tde-19112008-161404

Document

Doctoral Thesis

Author

Cavalcanti, Alexandre Biasi (Catálogo USP)

Full name

Alexandre Biasi Cavalcanti

E-mail

Institute/School/College

Faculdade de Medicina

Knowledge Area

Preventive Medicine

Date of Defense

2008-09-04

Published

São Paulo, 2008

Supervisor

Eluf Neto, Jose (Catálogo USP)

Committee

Eluf Neto, Jose (President)
Figueiredo, Luiz Francisco Poli de
Gouveia, Nelson da Cruz
Sá, João Roberto de
Silva, Eliezer

Title in Portuguese

Estudo randomizado, aberto, para avaliação da eficácia e segurança de dois protocolos para infusão de insulina endovenosa e um protocolo de administração de insulina subcutânea, em pacientes gravemente enfermos

Keywords in Portuguese

Eficácia
Insulina
Pacientes internados
Protocolos

Abstract in Portuguese

Introdução: Controle glicêmico estrito tem sido recomendado para pacientes gravemente enfermos. Entretanto, sua implementação pode ser difícil devido à sobrecarga da equipe de enfermagem, controle inadequado da glicemia e aumento do risco de hipoglicemia. Objetivos: Avaliar a eficácia e segurança de três protocolos de administração de insulina para controle glicêmico em pacientes clínicos admitidos em unidades de terapia intensiva (UTI). Métodos: Foram incluídos pacientes clínicos admitidos em UTI com ao menos uma glicemia maior ou igual a 150mg/dl e pelo menos uma das seguintes características: estar sob ventilação mecânica; politraumatismo; grande queimadura; apresentar ao menos 3 critérios de síndrome da resposta inflamatória sistêmica. Esses indivíduos foram alocados aleatoriamente para um dos seguintes tratamentos: protocolo A insulina regular endovenosa contínua (IREVC) visando manter glicemias entre 100mg/dL e 130mg/dL, com ajustes guiados por software para microcomputador ou handheld device; protocolo B - IREVC visando manter glicemias entre 80mg/dl e 110mg/dl; protocolo C insulina intermitente subcutânea, a partir de glicemias maiores do que 150mg/dl. Para cada paciente as medidas repetidas de glicemia foram sumarizadas como mediana. A avaliação de eficácia foi realizada comparando-se as médias de medianas de glicemia entre os grupos. A segurança foi avaliada comparando-se a incidência de hipoglicemia (40 mg/dl) entre os grupos. Resultados: Foram incluídos 167 pacientes. As médias e desvios-padrão calculados a partir das medianas de glicose foram de 125,0±17,7 mg/dl, 127,1±32,2mg/dl e 158,5±49,6 mg/dl para os pacientes alocados para os protocolos A, B e C, respectivamente (P<0,001 para comparação entre grupos A, B e C; P=0,34 para comparação entre grupo A e B). A incidência de hipoglicemia foi de 12 casos (21,4%) no protocolo A, 24 casos (41,4%) no protocolo B e 2 casos (3,8%) no grupo C (P<0,001 para comparação entre protocolos A, B e C; P=0,02 para comparação A versus B). Não houve diferenças de mortalidade ou quanto a outros desfechos clínicos entre os protocolos; exceto diferenças marginais na quantidade de dias sob noradrenalina (protocolo C

Title in English

Efficacy and safety of three insulin protocols in medical critically ill patients

Keywords in English

Efficacy
Inpatients
Insulin
Protocols

Abstract in English

Introduction: Strict glycemic control has been recommended for critically ill patients. However, its implementation may face difficulties with increased nursing workload, inadequate blood glucose control and higher risk of hypoglycemia. Objectives: To evaluate the efficacy and safety of three insulin protocols in medical ICU patients (MICU). Methods: MICU patients with at least one blood glucose of at least 150 mg/dL and one or more of the following characteristics were included: mechanical ventilation; at least three criteria for systemic inflammatory response syndrome; admitted because of trauma or burn. Patients were randomized to one of the following treatments: protocol A - continuous insulin infusion with adjustments guided by handheld device or desktop software targeting blood glucose levels between 100mg/dL-130mg/dL; protocol B continuous insulin aiming blood glucose levels between 80mg/dl-110mg/dl; protocol C conventional treatment intermittent subcutaneous administration of insulin if blood glucose levels exceeded 150mg/dL. Efficacy was measured by the mean of patients median blood glucose and safety was measured by the incidence of hypoglycemia (40 mg/dL). Results: 167 patients were included. Mean and standard deviation of patients median blood glucose was 125.0±17.7 mg/dl, 127.1±32.2mg/dl and 158.5±49.6 mg/dl for protocols A, B and C, respectively (P<0.001 for all protocol comparison; P=0.34 for protocol A versus B). 12 patients (21,4%) evolved with at least one episode of hypoglycemia in protocol A, 24 (41.4%) in protocol B, and 2(3.8%) in protocol C (P<0.001 for all protocol comparison; P=0.02 for protocol A versus B). There were no differences regarding mortality or other clinical outcome, except for a marginal difference on the number of days on norepinephrine (C < A < B). Conclusions: A computer guided insulin infusion protocol protocol A causes less episodes of hypoglycemia than and is as efficacious as the standard strict glycemic control protocol protocol B for controlling glucose at normal non-fasting levels (80 mg/dL 140mg/dL) in MICU patients. Hypoglycemia was rare under protocol C, however blood glucose levels were higher than protocol A or B

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Publishing Date

2008-12-15

Derived works

WARNING: The material described below relates to works resulting from this thesis or dissertation. The contents of these works are the author's responsibility.

Cavalcanti, A. B., et al. A randomized controlled trial comparing a computer-assisted insulin infusion protocol with a strict and a conventional protocol for glucose control in critically ill patients [doi:10.1016/j.jcrc.2009.05.005]. Journal of Critical Care [online], 2009, vol. 24, p. 371-378.
Cavalcanti, A. B., et al. A computer guided insulin protocol causes less hypoglycemia than a strict glycemic control protocol - A randomized controlled trial. In Eighth Wolf Creek Conference on Cardiopulmonary Resuscitation: Addressing the scientific basis of reanimation, ., 2006. CRITICAL CARE MEDICINE., 2006. Abstract.
Cavalcanti, A. B., et al. Efficacy and safety of three insulin protocols in medical intensive care unit patients. In III Simpósio "Avanços em Pesquisas Médicas dos Laboratórios de Investigação Médica do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo", São Paulo, 2007. Clinics., 2007. Resumo.