- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01728896
Patient-Initiated and ConTrolled Oral Refeeding (PICTOR) (PICTOR)
A Randomized Controlled Trial of Patient-Initiated and ConTrolled Oral Refeeding in Acute Pancreatitis
The first step in treating patients with acute pancreatitis is to provide pain relief and intravenous fluids to keep them comfortable. As the pain subsides and patient starts to feel better food and fluids by mouth are restarted. This is done to rest the pancreas which is the organ that has been inflamed.
In some patients when food by mouth restarts they have pain and as a consequence they have a longer stay in hospital. It is thought that patients who have little pain and are within 24 hours of admission to hospital do well if they control their own food intake. This is in contrast to the usual treatment where the treating team advise when eating should restart.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
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Auckland, Nova Zelândia
- University of Auckland; Auckland City Hospital
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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:
- diagnosis of acute pancreatitis
- age > 18 years
- written informed consent
Exclusion Criteria:
- ongoing need for opiates
- >96 hours after onset of symptoms
- chronic pancreatitis
- post-ERCP pancreatitis
- intraoperative diagnosis
- pregnancy
- malignancy
- received nutrition before randomisation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Sem intervenção: Gestão convencional
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Experimental: Patient-controlled oral refeeding
Patients will be allowed to drink and eat hospital food freely as tolerated.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Oral food intolerance
Prazo: Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Time from admission until tolerance of oral food
Prazo: Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
|
Total length of hospital stay
Prazo: Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
|
Need for opiates
Prazo: Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
Need for opiates is defined when one (or more) of the following has been administered:
|
Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
Change in pain intensity
Prazo: Baseline and 24, 48, 72h after randomisation
|
Baseline and 24, 48, 72h after randomisation
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Progression of acute pancreatitis severity
Prazo: Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
To be defined according to the 2012 determinant-based classification of acute pancreatitis severity
|
Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
Hospital readmission
Prazo: 2 weeks after hospital discharge
|
2 weeks after hospital discharge
|
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Local and systemic complications
Prazo: Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
To be defined according to the 2012 determinant-based classification of acute pancreatitis severity
|
Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
Number and type of interventions during hospital stay
Prazo: Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
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Time from admission until first flatus
Prazo: Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
Participants will be followed for the duration of hospital stay, an expected average of 7 days
|
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Change in blood glucose
Prazo: Baseline and 24, 48, 72h after randomisation
|
Baseline and 24, 48, 72h after randomisation
|
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Change in plasma C-reactive protein
Prazo: Baseline and 24, 48, 72h after randomisation
|
Baseline and 24, 48, 72h after randomisation
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
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
- NTX/12/06/051
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