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临床试验/NCT03286439
NCT03286439已完成不适用

Recovery After Medical or Surgical Treatment - A Prospective Cohort Study

Zealand University Hospital1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2017年11月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
1
主要终点
Cognitive function

研究概览

简要总结

This study aims to investigate the in-hospital care as well as the cognitive status, quality of life, physical function and risk of anxiety and depression, sleep disorders and drug use in a Danish cohort of both medical and surgical patients with acute critical illness without admittance to ICU (Intensive Care Unit) treatment, at three and twelve months after hospital discharge.

详细描述

A stay at the ICU (intensive Care Unit) is related to life-threatening conditions and often displays a major impact on both physical and mental resources of the patients. Studies show that a great part of ICU patients have impairments of both physical and psychological kinds, some long-lasting. This condition is termed the "post intensive care syndrome" (PICS) and describes a wide range of symptoms as fatigue, depression, anxiety, memory loss along with both cognitive and physical impairments. Rehabilitative efforts are, thus, needed, and it has been suggested that ideally, rehabilitation should begin at the time of admission to the hospital and continue for a long time, possibly years, after the patient has been discharged. Regarding long term cognitive function of the ICU survivors in particular, recent studies have demonstrated severe impairment at the level of light Alzheimer's disease. In all of these studies, the reference group is the normal population, and it is a general problem that the cognitive and physical function of ICU patients before critical illness is unknown. There has recently been a norwegian study that included a reference group of surgical patients undergoing major surgery. The surgical group was older and more severely ill than the ICU group and was found to have a much worse cognitive function. Moreover, the cognitive function of the critically ill patients was not very far from the normal reference population due to selection.

To determine to which degree the impairments can be attributed to ICU-admission, the investigators need to look at a hospitalised and representative, non-ICU population, which is what will be done in the study. The investigators will therefore include patients that have been admitted to surgical or medical department acute without admittance to the ICU and contact these patients 3 and 12 months after admission. Where there will be performed different tests in order to evaluate the the cognitive status, quality of life, physical function and risk of anxiety and depression, sleep disorders and drug use.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients > 18 years of age
  • Admitted to surgical or medical department > 3 days
  • Admitted with one of the following diagnoses:
  • Pneumonia
  • Heart failure
  • Pulmonary embolism
  • Acute myocardial infarction
  • Pyelonephritis
  • Patients undergoing non-elective open or laparoscopic abdominal surgery (not including elective procedures, diseases of the appendix, diseases of the gallbladder, liver, spleen, kidney, pancreas and emergency hernia surgery without bowel resection)

排除标准

  • Permanently incompetent patients not able to consent
  • Not able to speak and understand Danish
  • Discharged from the hospital for terminal care
  • Patients transferred to another hospital during the stay
  • Patients living outside the Region of Zealand
  • Patients admitted under duress or actively psychotic
  • Patients that are blind or severely visually impaired.

结局指标

主要结局

Cognitive function

时间窗: 3 months after discharge

Cognitive Function measured by The Repeatable Battery for The Assesment of Neuropsychological Status (RBANS)

次要结局

  • Information processing speed(12 months after discharge)
  • Cognitive function after one year(12 months after discharge)
  • Rehabilitation after 3 months(3 months after discharge)
  • Self-reported health related quality of life(12 months after discharge)
  • Objective assessment of physical function(12 months after discharge)
  • Mortality(90 days after discharge)
  • Consumption of opioids(90 days after discharge)
  • Consumption of statins days after discharge(90 days after discharge)
  • Consumption of anti-depressants(90 days after discharge)
  • Sleepiness(12 months after discharge)
  • Insomnia(12 months after discharge)
  • Sleep Quality(12 months after discharge)
  • Executive function(12 months after discharge)
  • Rehabilitation after 12 months(12 months)
  • Consumption of sleep medication(12 months after discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stine Estrup

Principal Investigator

Zealand University Hospital

研究点 (1)

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