Clinical trial NCT02599428: Recovery After ICU Treatment: A Prospective Cohort Study
Official title: Recovery After ICU Treatment: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Critical Illness
Quality of Life
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2015-11-06
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the ICU at Zealand University Hospital, Køge, in the study period

Brief summary: This project aims to investigate the physical, mental and cognitive recovery after admission to the Intensive Care Unit (ICU).

This will be done by a three and 12 month follow up after discharge. The patients will be scored with four validated methods for evaluating their health related quality of life, anxiety and depression, cognitive function and physical impairments

Detailed description: An increasing number of patients are treated at ICUs worldwide. The majority of these patients survive critical illness and are discharged from the hospital. A stay at the ICU is most often related to life-threatening conditions and displays a major impact on both physical and mental resources of the patients. Studies have shown that a great part of these patients also have physical and psychological impairments lasting for a long period after their hospital stay. The condition is termed the "post intensive care syndrome" (PICS) and describes a state with wide range of symptoms as fatigue, depression, anxiety, memory loss as well as both cognitive and physical impairment. During the first five years after discharge, more than half of ICU survivors had suffered at least one episode of depression or anxiety

ICU treatment often involves immobilization and sedation that may lead to both muscle weakness, critical illness myopathy and/or polyneuropathy. This may not only affect the patients during the ICU or hospital stay, but also for a longer post-discharge period. A recent study demonstrated that measured physical health related quality of life was impaired for up to one year after hospitalization, and that the physical performance at five years post-discharge continued to be lower than in the background population. The physical impairments may also influence patient's working ability, and among previously working individuals only half had returned to work within the first year after ICU hospitalization. After five years, up to 25 % still had not returned to work.

In Denmark, more than 30.000 people are annually admitted to intensive care units. The annual report from the Danish Intensive Care Database (DID) present data regarding a variety of outcomes, including length of stay, survival rate and 90 days re-admission to hospital. The reports demonstrate an increased quality of care but offer limited information on longer term outcome including quality of life for these patients. A recent study have indicated that Danish patients might suffer from the same psychological and physical impairments as found in international studies, but a better characteristic of the population is needed. Especially since the level of public care, including early rehabilitation in hospital differs between countries.

It is therefore essential to investigate and describe the needs, standard of care and the physical and cognitive status of these patients both in-hospital and post-discharge in order to establish the right level of aftercare for the Danish population. This study aims at investigating the in-hospital care as well as the physical and cognitive status of a Danish cohort of ICU patients at 3 and 12 month post-discharge.

The investigators plan to do a substudy regarding exposure to circadian light and delirium.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years of age
* Admitted to the ICU for \> 24 h

Exclusion Criteria:

* Not able to speak and understand Danish
* Discharged from the ICU to terminal care
* Patients transferred to another hospital during ICU stay
* Patients living outside the Region of Zealand
* Patient with severe dementia

Primary outcomes:
measure: Cognitive function measured by Repeatable Battery for the Assessments of Neuropsychological Status (RBANS)
timeFrame: 3 months after discharge
Secondary outcomes:
measure: Adherence to checklist based on rehabilitation guidelines
timeFrame: At discharge from hospital and 3 months
measure: Health related quality of life measured by Short form health survey (SF 36)
timeFrame: 3 and 12 months
measure: Anxiety and depression measured by Hospital anxiety and depression scale (HADS)
timeFrame: 3 and 12 months
measure: Physical function measured by Chelsea critical care physical assessment tool (CPAx)
timeFrame: 3 and 12 months
measure: Mortality
timeFrame: At discharge from hospital (variable time) and at 90 days postdischarge
measure: Delirium at the ICU measured by CAM-ICU
timeFrame: At discharge from ICU (variable time)
measure: Consumption of opioids at admission and on follow up
timeFrame: At admission to hospital, at 3 month follow up
measure: Consumption of anti-depressants before and after ICU stay
timeFrame: At admission to hospital, at 3 month follow up
measure: Receiving statins before and after ICU stay
timeFrame: At admission to hospital, at 3 month follow up
measure: Cognitive function measured by Repeatable Battery for the Assessments of Neuropsychological Status (RBANS)
timeFrame: 12 months after discharge
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: University Hospital Zealand, Køge
Study officials:
affiliation: Zealand University Hospital, Køge Hospital
name: Ole Mathiesen, MD
role: STUDY_CHAIR
References:
citation: Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.
citation: Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.
citation: Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001 Jul;29(7):1370-9. doi: 10.1097/00003246-200107000-00012.
citation: Wolters A, Bouw M, Vogelaar J, Tjan D, van Zanten A, van der Steen M. The postintensive care syndrome of survivors of critical illness and their families. J Clin Nurs. 2015 Mar;24(5-6):876-9. doi: 10.1111/jocn.12678. Epub 2014 Dec 1. No abstract available.
citation: Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.
citation: Estrup S, Kjer CKW, Vilhelmsen F, Poulsen LM, Gogenur I, Mathiesen O. Physical function and actigraphy in intensive care survivors-A prospective 3-month follow-up cohort study. Acta Anaesthesiol Scand. 2019 May;63(5):647-652. doi: 10.1111/aas.13317. Epub 2019 Jan 8.