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DeliriumNCT02599428

Recovery After ICU Treatment: A Prospective Cohort Study

An observational study of Delirium and Critical Illness, run by Zealand University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Delirium, Critical Illness, Quality of Life
How many people
161 participants
Where
1 siteDenmark
Study dates
Feb 2016to May 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients admitted to the ICU at Zealand University Hospital, Køge, in the study period

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • University Hospital Zealand, Køge

    Køge, 4600

Other trials in Denmark

About this study

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

Read the 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.

Medical subject headings
Delirium, Critical Illness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive function measured by Repeatable Battery for the Assessments of Neuropsychological Status (RBANS)

    The Repeatable Battery for the Assessments of Neuropsychological Status (RBANS) evaluation status at 3 and 12 months after discharge from ICU

    Measured: 3 months after discharge

Secondary outcomes (10)

  1. Adherence to checklist based on rehabilitation guidelines

    Adherence to a checklist at discharge from ICU and hospital that evaluates rehabilitation efforts based on guidelines from NICE (the National Institute for Health and Care Excellence)

    Measured: At discharge from hospital and 3 months

  2. Health related quality of life measured by Short form health survey (SF 36)

    Short form health survey (SF 36) score at 3 and 12 month follow up

    Measured: 3 and 12 months

  3. Anxiety and depression measured by Hospital anxiety and depression scale (HADS)

    Hospital anxiety and depression scale (HADS) score at 3 and 12 month follow up

    Measured: 3 and 12 months

  4. Physical function measured by Chelsea critical care physical assessment tool (CPAx)

    Chelsea critical care physical assessment tool (CPAx) at 3 and 12 month follow up

    Measured: 3 and 12 months

  5. Mortality

    All cause mortality

    Measured: At discharge from hospital (variable time) and at 90 days postdischarge

  6. Delirium at the ICU measured by CAM-ICU

    Delirium during ICU stay, measured as days with a positive CAM-ICU score or CAM-ICU negative delirium treated with anti-psychotics

    Measured: At discharge from ICU (variable time)

  7. Consumption of opioids at admission and on follow up

    Percentage of patients with a daily consumption of opioids (strong/weak) at hospital admission and at 90 days discharge

    Measured: At admission to hospital, at 3 month follow up

  8. Consumption of anti-depressants before and after ICU stay

    Percentage of patients with a daily consumption of anti-depressants at hospital admission and at 90 days after discharge

    Measured: At admission to hospital, at 3 month follow up

  9. Receiving statins before and after ICU stay

    Percentage of patients with a daily consumption of statins at hospital admission and at 90 days after discharge

    Measured: At admission to hospital, at 3 month follow up

  10. Cognitive function measured by Repeatable Battery for the Assessments of Neuropsychological Status (RBANS)

    The Repeatable Battery for the Assessments of Neuropsychological Status (RBANS) evaluation status at 3 and 12 months after discharge from ICU

    Measured: 12 months after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completionMar 2018
  4. Study completionMay 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02599428
Sponsor's protocol ID
SE 1-16
Status last verified
May 2018
First submitted
4 Nov 2015
Last updated
30 May 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 21470008

  • 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.

    PubMed 24088092

  • 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.

    PubMed 11445689

  • 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.

    PubMed 25441007

  • 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.

    PubMed 12594312

  • 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.

    PubMed 30623414

Questions about this trial

What is this clinical trial studying?

An observational study of Delirium and Critical Illness, run by Zealand University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive function measured by Repeatable Battery for the Assessments of Neuropsychological Status (RBANS) (time frame: 3 months after discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02599428, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.

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