Recovery After Medical or Surgical Treatment

NCT ID: NCT03286439

Last Updated: 2018-09-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 101 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-13
• Study Completion Date: 2018-07-06

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.

Conditions

Cognitive Deficit

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

there 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zealand University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Stine Estrup

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stine Estrup, MD

Role: PRINCIPAL_INVESTIGATOR

Stine Estrup

Locations

Zealand University Hospital

Køge, , Denmark

Countries

Denmark

Other Identifiers

NA-1-2017

Identifier Type: -

Identifier Source: org_study_id