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Recovery After Medical or Surgical Treatment

Recovery After Medical or Surgical Treatment - A Prospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03286439
Enrollment
101
Registered
2017-09-18
Start date
2017-11-13
Completion date
2018-07-06
Last updated
2018-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Deficit

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.

Interventions

OTHERthere will be offered a follow up visit

The investigators will offer the patients a follow up visit 3 and 12 months after discharge from the hospital.

Sponsors

Zealand University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cognitive function3 months after dischargeCognitive Function measured by The Repeatable Battery for The Assesment of Neuropsychological Status (RBANS)

Secondary

MeasureTime frameDescription
Rehabilitation after 3 months3 months after dischargeThis will be investigated by filling out a checklist of community support and contact to health care system at 3 month follow up
Self-reported health related quality of life3 months after dischargeThis will be investigated by filling out a questionnaire named SF 36, Short Form Health Survey.
Objective assessment of physical function3 months after dischargeThis will be investigated by filling out a checklist called CPAx, The Chelsea Critical Care Physical Assessment Tool.
Mortality90 days after dischargeThe mortality of the patients within 90 days after hospital discharge.
Consumption of opioids90 days after dischargePercentage of patients with a daily consumption of opioids at hospital admission and 90 days after discharge
Consumption of statins days after discharge90 days after dischargePercentage of patients with a daily consumption of statins at hospital admission and at 90 days after discharge
Consumption of anti-depressants90 days after dischargePercentage of patients with a daily consumption of anti-depressants at hospital admission and at 90 days after discharge
Cognitive function after one year12 months after dischargeCognitive function measured with The Repeatable Battery for the Assessments of Neuropsychological Status (RBANS) evaluation at 12 months after discharge from hospital
InsomniaAt inclusionThis will be investigated by filling out Insomnia Severity Index
Sleep QualityAt inclusionThis will be investigated by filling out Pittsburgh Sleep Quality Index
Information processing speed3 months after dischargeThis will be investigated by filling out the Trail Making Test Part A
Executive function3 months after dischargeThis will be investigated by filling out the Trail Making Test Part B
Rehabilitation after 12 months12 monthsThis will be investigated by filling out a checklist of Community support and contact to health care system at 3 month follow up
Consumption of sleep medicationAt inclusionPercentage of patients with a daily consumption of sleep medication at hospital admission and 90 days after discharge
SleepinessAt inclusionThis will be investigated by filling out Epworth Sleepiness Scale

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026