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- Ensaio Clínico NCT01526044
Continuous Glucose Monitoring by Subcutaneous Measurement Compared to Frequent Point of Care Measurement by Accu Chek in Critically Ill Patients (RESCUEII)
Continuous Glucose Monitoring by Subcutaneous Measurement Compared to Frequent Point of Care Measurement by Accu Chek in Critically Ill Patients; a Randomized Controlled Trial (RESCUEII)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Most patients admitted to the ICU are treated with intensive insulin therapy, according to a locally developed glucose treatment protocol. The use of a continuous glucose monitoring in critically ill patients could have the following advantages:
- Better insight in the alterations of the blood glucose levels
- Early detection of hypoglycemia's or hyperglycaemia's, and subsequently more stable glycemic levels.
- Fewer blood samples
- Decreased workload for the nursing staff
In this study, patients will be randomized in: 1. The Freestyle group or 2. The AccuChek Group.
Patients in both groups will receive a Freestyle Navigator device, which will stay on the patient up to 5 days, or until discharge from the ICU.
The medical treatment of both study groups will be equal, except for the frequency of the glucose level measurements and the resulting adjustments according to the treatment protocol. In the Freestyle group extra glucose level measurements will be made in response to alarms from the device.
In both groups, every 4 hours blood glucose values will be obtained using a blood gas analyzer (BGA). When a control measurement by BGA results in a glucose level of <2.2 or >25 mmol/l, the value will be transmitted to the Patient Data Management System (PDMS) and gives an alarm. Otherwise, the value will be blinded in the PDMS.
Freestyle Navigator data will be downloaded from the device. Blood glucose values obtained in the course of usual care will be compared with time-matched Freestyle Navigator values to assess device accuracy.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Amsterdam, Holanda
- Onze Lieve Vrouwe Gasthuis
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- ICU-patients > 18 years
- Expected length of stay on the ICU > 24 hours
- Indication for glucose regulation with insulin (according to the current glucose treatment protocol)
- Availability of the Freestyle Navigator
Exclusion Criteria:
- Participation in another trial subject to the WMO
- Lack of informed consent
- Contraindication for the use of the Accu Chek (for example peritoneal dialysis, Ht <0,20 of > 0,65; paracetamol intoxication)
- Contraindication for placement of the subcutaneous glucose sensor
- Participation in this trial during previous ICU admittance
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Freestyle group
Glucose levels are being monitored with the Freestyle Navigator up to 5 days, or until discharge from the ICU
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Continuous glucose monitoring by subcutaneous measurement in the interstitial fluid
Outros nomes:
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Comparador Ativo: AccuChek group
Glucose levels are being measured by the AccuChek.
Patients also get a Freestyle Navigator, which will be blinded.
The device will stay on the patient up to 5 days, or until discharge from the ICU.
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Continuous glucose monitoring by subcutaneous measurement in the interstitial fluid
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
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Number of severe hyperglycaemias and hypoglycaemias with blood glucose levels >25 mmol/l and <2.2 mmol/l
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Mortalidade
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Length of stay in the ICU
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Time duration that the blood glucose levels of a patient are within the 'target range' (measured with the freestyle Navigator®)
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The target range in the ICU of the OLVG is set between 5 and 9 mmol/l according to the local treatment protocol
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Time duration that the blood glucose levels of a patient are under and above the 'target range' (measured with the freestyle Navigator®)
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The target range in the ICU of the OLVG is set between 5 and 9 mmol/l according to the local treatment protocol
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- Variability of the glycemic levels by arterial measuring with the blood gas analyzer (BGA), determined by the Mean Absolute Glucose change per hour (MAG)
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Mean Absolute Glucose change per hour: ΔBGA / Δtime The MAG is calculated by taking the sum of all absolute glucose changes during admission (measured by BGA) and dividing this by the total time spent in the ICU in hours. |
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False positive frequency of alarms of the Freestyle Navigator®
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Verified by the glucose level measurements by blood gas analyzer
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Number of undesirable low glucose levels per 24 hours
Prazo: 24 hours
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blood glucose levels between 2,5 and 5 mmol/l
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24 hours
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Number of missed hypoglycemia's with the AccuChek (measured with the Freestyle Navigator®)
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Number of blood samples per day
Prazo: 24 hours
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24 hours
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: P HJ van der Voort, MD, PhD, Onze Lieve Vrouwe Gasthuis
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NL33495.100.10
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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