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Clinical Trials/NCT03286439
NCT03286439
Completed
Not Applicable

Recovery After Medical or Surgical Treatment - A Prospective Cohort Study

Zealand University Hospital1 site in 1 country101 target enrollmentNovember 13, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Deficit
Sponsor
Zealand University Hospital
Enrollment
101
Locations
1
Primary Endpoint
Cognitive function
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 13, 2017
End Date
July 6, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stine Estrup

Principal Investigator

Zealand University Hospital

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Cognitive function

Time Frame: 3 months after discharge

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

Secondary Outcomes

  • 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)

Study Sites (1)

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