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Recovery After ICU Treatment: A Prospective Cohort Study

29 de maio de 2018 atualizado por: Stine Estrup, Zealand University Hospital

This project aims to investigate the physical, mental and cognitive recovery after admission to the Intensive Care Unit (ICU).

This will be done by a three and 12 month follow up after discharge. The patients will be scored with four validated methods for evaluating their health related quality of life, anxiety and depression, cognitive function and physical impairments

Visão geral do estudo

Status

Concluído

Descrição detalhada

An increasing number of patients are treated at ICUs worldwide. The majority of these patients survive critical illness and are discharged from the hospital. A stay at the ICU is most often related to life-threatening conditions and displays a major impact on both physical and mental resources of the patients. Studies have shown that a great part of these patients also have physical and psychological impairments lasting for a long period after their hospital stay. The condition is termed the "post intensive care syndrome" (PICS) and describes a state with wide range of symptoms as fatigue, depression, anxiety, memory loss as well as both cognitive and physical impairment. During the first five years after discharge, more than half of ICU survivors had suffered at least one episode of depression or anxiety

ICU treatment often involves immobilization and sedation that may lead to both muscle weakness, critical illness myopathy and/or polyneuropathy. This may not only affect the patients during the ICU or hospital stay, but also for a longer post-discharge period. A recent study demonstrated that measured physical health related quality of life was impaired for up to one year after hospitalization, and that the physical performance at five years post-discharge continued to be lower than in the background population. The physical impairments may also influence patient's working ability, and among previously working individuals only half had returned to work within the first year after ICU hospitalization. After five years, up to 25 % still had not returned to work.

In Denmark, more than 30.000 people are annually admitted to intensive care units. The annual report from the Danish Intensive Care Database (DID) present data regarding a variety of outcomes, including length of stay, survival rate and 90 days re-admission to hospital. The reports demonstrate an increased quality of care but offer limited information on longer term outcome including quality of life for these patients. A recent study have indicated that Danish patients might suffer from the same psychological and physical impairments as found in international studies, but a better characteristic of the population is needed. Especially since the level of public care, including early rehabilitation in hospital differs between countries.

It is therefore essential to investigate and describe the needs, standard of care and the physical and cognitive status of these patients both in-hospital and post-discharge in order to establish the right level of aftercare for the Danish population. This study aims at investigating the in-hospital care as well as the physical and cognitive status of a Danish cohort of ICU patients at 3 and 12 month post-discharge.

The investigators plan to do a substudy regarding exposure to circadian light and delirium.

Tipo de estudo

Observacional

Inscrição (Real)

161

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

      • Køge, Dinamarca, 4600
        • University Hospital Zealand, Køge

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 e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Patients admitted to the ICU at Zealand University Hospital, Køge, in the study period

Descrição

Inclusion Criteria:

  • Patients > 18 years of age
  • Admitted to the ICU for > 24 h

Exclusion Criteria:

  • Not able to speak and understand Danish
  • Discharged from the ICU to terminal care
  • Patients transferred to another hospital during ICU stay
  • Patients living outside the Region of Zealand
  • Patient with severe dementia

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Cognitive function measured by Repeatable Battery for the Assessments of Neuropsychological Status (RBANS)
Prazo: 3 months after discharge
The Repeatable Battery for the Assessments of Neuropsychological Status (RBANS) evaluation status at 3 and 12 months after discharge from ICU
3 months after discharge

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Adherence to checklist based on rehabilitation guidelines
Prazo: At discharge from hospital and 3 months
Adherence to a checklist at discharge from ICU and hospital that evaluates rehabilitation efforts based on guidelines from NICE (the National Institute for Health and Care Excellence)
At discharge from hospital and 3 months
Health related quality of life measured by Short form health survey (SF 36)
Prazo: 3 and 12 months
Short form health survey (SF 36) score at 3 and 12 month follow up
3 and 12 months
Anxiety and depression measured by Hospital anxiety and depression scale (HADS)
Prazo: 3 and 12 months
Hospital anxiety and depression scale (HADS) score at 3 and 12 month follow up
3 and 12 months
Physical function measured by Chelsea critical care physical assessment tool (CPAx)
Prazo: 3 and 12 months
Chelsea critical care physical assessment tool (CPAx) at 3 and 12 month follow up
3 and 12 months
Mortality
Prazo: At discharge from hospital (variable time) and at 90 days postdischarge
All cause mortality
At discharge from hospital (variable time) and at 90 days postdischarge
Delirium at the ICU measured by CAM-ICU
Prazo: At discharge from ICU (variable time)
Delirium during ICU stay, measured as days with a positive CAM-ICU score or CAM-ICU negative delirium treated with anti-psychotics
At discharge from ICU (variable time)
Consumption of opioids at admission and on follow up
Prazo: At admission to hospital, at 3 month follow up
Percentage of patients with a daily consumption of opioids (strong/weak) at hospital admission and at 90 days discharge
At admission to hospital, at 3 month follow up
Consumption of anti-depressants before and after ICU stay
Prazo: At admission to hospital, at 3 month follow up
Percentage of patients with a daily consumption of anti-depressants at hospital admission and at 90 days after discharge
At admission to hospital, at 3 month follow up
Receiving statins before and after ICU stay
Prazo: At admission to hospital, at 3 month follow up
Percentage of patients with a daily consumption of statins at hospital admission and at 90 days after discharge
At admission to hospital, at 3 month follow up
Cognitive function measured by Repeatable Battery for the Assessments of Neuropsychological Status (RBANS)
Prazo: 12 months after discharge
The Repeatable Battery for the Assessments of Neuropsychological Status (RBANS) evaluation status at 3 and 12 months after discharge from ICU
12 months after discharge

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Cadeira de estudo: Ole Mathiesen, MD, Zealand University Hospital, Køge Hospital

Publicações e links úteis

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Publicações Gerais

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 fevereiro de 2016

Conclusão Primária (Real)

1 de março de 2018

Conclusão do estudo (Real)

1 de maio de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

4 de novembro de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de novembro de 2015

Primeira postagem (Estimativa)

6 de novembro de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de maio de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de maio de 2018

Última verificação

1 de maio de 2018

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • SE 1-16

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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