Clinical trial NCT03286439: Recovery After Medical or Surgical Treatment
Official title: Recovery After Medical or Surgical Treatment - A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Deficit
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of critically ill patients that have been admitted to surgical or Medical departement.

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.

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.

Primary outcomes:
measure: Cognitive function
timeFrame: 3 months after discharge
Secondary outcomes:
measure: Cognitive function after one year
timeFrame: 12 months after discharge
measure: Rehabilitation after 3 months
timeFrame: 3 months after discharge
measure: Self-reported health related quality of life
timeFrame: 3 months after discharge
measure: Self-reported health related quality of life
timeFrame: 12 months after discharge
measure: Objective assessment of physical function
timeFrame: 3 months after discharge
measure: Objective assessment of physical function
timeFrame: 12 months after discharge
measure: Mortality
timeFrame: 90 days after discharge
measure: Consumption of opioids
timeFrame: 90 days after discharge
measure: Consumption of statins days after discharge
timeFrame: 90 days after discharge
measure: Consumption of anti-depressants
timeFrame: 90 days after discharge
measure: Sleepiness
timeFrame: At inclusion
measure: Sleepiness
timeFrame: 3 months after discharge
measure: Sleepiness
timeFrame: 12 months after discharge
measure: Insomnia
timeFrame: At inclusion
measure: Insomnia
timeFrame: 3 months after discharge
measure: Insomnia
timeFrame: 12 months after discharge
measure: Sleep Quality
timeFrame: At inclusion
measure: Sleep Quality
timeFrame: 3 months after discharge
measure: Sleep Quality
timeFrame: 12 months after discharge
measure: Information processing speed
timeFrame: 3 months after discharge
measure: Information processing speed
timeFrame: 12 months after discharge
measure: Executive function
timeFrame: 3 months after discharge
measure: Executive function
timeFrame: 12 months after discharge
measure: Rehabilitation after 12 months
timeFrame: 12 months
measure: Consumption of sleep medication
timeFrame: At inclusion
measure: Consumption of sleep medication
timeFrame: 90 days after discharge
measure: Consumption of sleep medication
timeFrame: 12 months after discharge
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: Stine Estrup
name: Stine Estrup, MD
role: PRINCIPAL_INVESTIGATOR
References: