Recovery After ICU Treatment: A Prospective Cohort Study

NCT02599428 | Completed DMC

• 1 other identifier: SE 1-16
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

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

Conditions

Delirium; Critical Illness; Quality of Life

Outcome Measures

Primary Outcomes (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

  3 months after discharge

Secondary Outcomes (10)

• Adherence to checklist based on rehabilitation guidelines

  At discharge from hospital and 3 months

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

  3 and 12 months

• Anxiety and depression measured by Hospital anxiety and depression scale (HADS)

  3 and 12 months

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

  3 and 12 months

• Mortality

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

University Hospital Zealand, Køge

Køge, 4600, Denmark

Location

Related Publications (6)

• 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.

  PMID: 21470008 BACKGROUND

• 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.

  PMID: 24088092 BACKGROUND

• 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.

  PMID: 11445689 BACKGROUND

• 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.

  PMID: 25441007 BACKGROUND

• 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.

  PMID: 12594312 BACKGROUND

• 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.

  PMID: 30623414 DERIVED

MeSH Terms

Conditions

Delirium; Critical Illness

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes

Study Officials

• Ole Mathiesen, MD

  Zealand University Hospital, Køge Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Doctor, PhD Student

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 6, 2015
• Study Start: February 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 30, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)