- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00830193
N-Acetylcysteine in Critically Ill Patients Undergoing Contrast Enhanced Computed Tomography
N-Acetylcysteine in Critically Ill Patients Undergoing Contrast Enhanced Computed Tomography: A Randomized Trial
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Potential participants were identified by staff intensivists or resident physicians following admission to participating ICUs. We included critically ill adult patients at least 18 years of age who consented to participate in the trial, had central venous access and a foley catheter, required a contrast-enhanced CT of any organ system(s), and were considered 'at risk' for the development of CIN. We defined 'at risk' to include patients with at least one of the following at the time of randomization (i) a serum creatinine of > 106 µmol/L and or urea > 6 mmol/L, (ii) urine output of < 0.5 cc/kg over > 4 hrs or (iii) an increase in serum creatinine of > 50 µmol/L in < 24 hours. We stratified based on the presence or absence of diabetes defined as a history of treatment with oral hypoglycemics or insulin.
We excluded patients with a (i) CK > 5,000 or the presence of myoglobinuria, (ii) a known allergy or hypersensitivity reaction to radiographic contrast dye or NAC, (iii) serious illness with imminent threat of dying (low likelihood of survival within 48-hours) or poor prognosis, (iv) pregnancy, (v) patients with cardiogenic shock (NYHA class 3 or 4 symptoms), (vi) known or suspected nephritic, nephrotic or pulmonary-renal syndromes, (vii) a post renal etiology of renal impairment, (viii) previous renal transplant, (ix) known solitary kidney, (x) serum creatinine > 200 µmol/L or (xi) recent exposure to radiographic contrast within 14 days of randomization.
The primary outcome for the study was the development of CIN defined as a rise in serum creatinine of > 50 µmol/L from the time of randomization up to day 5 following contrast exposure.
Secondary outcomes included ICU and hospital length of stay, ICU and hospital mortality and the requirement for renal replacement therapy. We recorded compliance with assigned treatment and assessed for development of severe unexpected adverse events defined as hypotension, bronchospasm and anaphylactic reactions.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Locais de estudo
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Ontario
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London, Ontario, Canadá, N6A 4G5
- London Health Sciences Centre - Victoria Hospital
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London, Ontario, Canadá, N6A 5A5
- London Health Sciences Centre - University Hospital Campus
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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:
- The investigators included critically ill adult patients at least 18 years of age who consented to participate in the trial, had central venous access and a foley catheter, required a contrast-enhanced CT of any organ system(s), and were considered 'at risk' for the development of CIN.
- The investigators defined 'at risk' to include patients with at least one of the following at the time of randomization (i) a serum creatinine of > 106 µmol/L and or urea > 6 mmol/L, (ii) urine output of < 0.5 cc/kg over > 4 hrs or (iii) an increase in serum creatinine of > 50 µmol/L in < 24 hours.
Exclusion Criteria:
The investigators excluded patients with a
- CK > 5,000 or the presence of myoglobinuria
- a known allergy or hypersensitivity reaction to radiographic contrast dye or NAC
- serious illness with imminent threat of dying (low likelihood of survival within 48-hours) or poor prognosis
- pregnancy
- patients with cardiogenic shock (NYHA class 3 or 4 symptoms)
- known or suspected nephritic, nephrotic or pulmonary-renal syndromes
- a post renal etiology of renal impairment
- previous renal transplant
- known solitary kidney
- serum creatinine > 200 µmol/L or (xi) recent exposure to radiographic contrast within 14 days of randomization.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: N-acetylcysteine
Intravenous fluid administration was administered as soon as possible following randomization (not to exceed 12 hours prior to anticipated contrast exposure) and continued for 12 hours post CT.
Patients randomized to the experimental arm received intravenous normal saline plus NAC 10 grams IV (5 g pre and 2.5 g at 6 and 12 hours post-exposure) for a total of 3 doses.
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Medication packages were prepared and dispensed by pharmacy and included three premixed and prepackaged minibags containing either 5 g of NAC or placebo in 100 cc D5W (pre-CT dose) or 2.5 g of NAC or placebo in 50 cc D5W (post-CT doses).
Outros nomes:
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Comparador de Placebo: Placebo
Intravenous fluid administration was administered as soon as possible following randomization (not to exceed 12 hours prior to anticipated contrast exposure) and continued for 12 hours post CT.
Medication packages were prepared and dispensed by pharmacy and included three premixed and prepackaged minibags containing either 5 g in 100 cc D5W (pre-CT dose) or 2.5 g in 50 cc D5W (post-CT doses).
The placebo was D5W and was colour and consistency matched by pharmacy.
Patients randomized to placebo received intravenous normal saline plus 3 doses of placebo.
|
Medication packages were prepared and dispensed by pharmacy and included three premixed and prepackaged minibags containing either 5 g of NAC or placebo (D5W) in 100 cc D5W (pre-CT dose) or 2.5 g NAC or placebo in 50 cc D5W (post-CT doses).
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
The primary outcome for the study was the development of CIN defined as a rise in serum creatinine of > 50 µmol/L from the time of randomization up to day 5 following contrast exposure.
Prazo: 5 days
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5 days
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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ICU length of stay
Prazo: ICU stay
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ICU stay
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Hospital length of stay
Prazo: Hospital stay
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Hospital stay
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Mortalidade na UTI
Prazo: Permanência na UTI
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Permanência na UTI
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Hospital Mortality
Prazo: Hospital stay
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Hospital stay
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Requirement for Renal Replacement Therapy
Prazo: ICU
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ICU
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Claudio M Martin, MD, FRCPC, MSc, London Health Sciences Centre - Victoria Hospital
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
Termos MeSH relevantes adicionais
- Processos Patológicos
- Doenças Urológicas
- Atributos da doença
- Doenças renais
- Doença grave
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Anti-Infecciosos
- Antivirais
- Agentes de proteção
- Agentes do Sistema Respiratório
- Antioxidantes
- Antídotos
- Eliminadores de Radicais Livres
- Expectorantes
- Acetilcisteína
- N-monoacetilcistina
Outros números de identificação do estudo
- LHRI-000001
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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