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Recovery After ICU Treatment: A Prospective Cohort Study

2018년 5월 29일 업데이트: 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

연구 개요

상태

완전한

상세 설명

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.

연구 유형

관찰

등록 (실제)

161

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Køge, 덴마크, 4600
        • University Hospital Zealand, Køge

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Cognitive function measured by Repeatable Battery for the Assessments of Neuropsychological Status (RBANS)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Adherence to checklist based on rehabilitation guidelines
기간: 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)
기간: 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)
기간: 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)
기간: 3 and 12 months
Chelsea critical care physical assessment tool (CPAx) at 3 and 12 month follow up
3 and 12 months
Mortality
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 의자: Ole Mathiesen, MD, Zealand University Hospital, Køge Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2016년 2월 1일

기본 완료 (실제)

2018년 3월 1일

연구 완료 (실제)

2018년 5월 1일

연구 등록 날짜

최초 제출

2015년 11월 4일

QC 기준을 충족하는 최초 제출

2015년 11월 5일

처음 게시됨 (추정)

2015년 11월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 5월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 5월 29일

마지막으로 확인됨

2018년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • SE 1-16

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

삶의 질에 대한 임상 시험

3
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