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Recovery After ICU Treatment: A Prospective Cohort Study

29. Mai 2018 aktualisiert von: Stine Estrup, Zealand University Hospital

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

Studienübersicht

Status

Abgeschlossen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

161

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Køge, Dänemark, 4600
        • University Hospital Zealand, Køge

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cognitive function measured by Repeatable Battery for the Assessments of Neuropsychological Status (RBANS)
Zeitfenster: 3 months after discharge
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Adherence to checklist based on rehabilitation guidelines
Zeitfenster: At discharge from hospital and 3 months
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)
At discharge from hospital and 3 months
Health related quality of life measured by Short form health survey (SF 36)
Zeitfenster: 3 and 12 months
Short form health survey (SF 36) score at 3 and 12 month follow up
3 and 12 months
Anxiety and depression measured by Hospital anxiety and depression scale (HADS)
Zeitfenster: 3 and 12 months
Hospital anxiety and depression scale (HADS) score at 3 and 12 month follow up
3 and 12 months
Physical function measured by Chelsea critical care physical assessment tool (CPAx)
Zeitfenster: 3 and 12 months
Chelsea critical care physical assessment tool (CPAx) at 3 and 12 month follow up
3 and 12 months
Mortality
Zeitfenster: At discharge from hospital (variable time) and at 90 days postdischarge
All cause mortality
At discharge from hospital (variable time) and at 90 days postdischarge
Delirium at the ICU measured by CAM-ICU
Zeitfenster: At discharge from ICU (variable time)
Delirium during ICU stay, measured as days with a positive CAM-ICU score or CAM-ICU negative delirium treated with anti-psychotics
At discharge from ICU (variable time)
Consumption of opioids at admission and on follow up
Zeitfenster: At admission to hospital, at 3 month follow up
Percentage of patients with a daily consumption of opioids (strong/weak) at hospital admission and at 90 days discharge
At admission to hospital, at 3 month follow up
Consumption of anti-depressants before and after ICU stay
Zeitfenster: At admission to hospital, at 3 month follow up
Percentage of patients with a daily consumption of anti-depressants at hospital admission and at 90 days after discharge
At admission to hospital, at 3 month follow up
Receiving statins before and after ICU stay
Zeitfenster: At admission to hospital, at 3 month follow up
Percentage of patients with a daily consumption of statins at hospital admission and at 90 days after discharge
At admission to hospital, at 3 month follow up
Cognitive function measured by Repeatable Battery for the Assessments of Neuropsychological Status (RBANS)
Zeitfenster: 12 months after discharge
The Repeatable Battery for the Assessments of Neuropsychological Status (RBANS) evaluation status at 3 and 12 months after discharge from ICU
12 months after discharge

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Studienstuhl: Ole Mathiesen, MD, Zealand University Hospital, Køge Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Februar 2016

Primärer Abschluss (Tatsächlich)

1. März 2018

Studienabschluss (Tatsächlich)

1. Mai 2018

Studienanmeldedaten

Zuerst eingereicht

4. November 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. November 2015

Zuerst gepostet (Schätzen)

6. November 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. Mai 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Mai 2018

Zuletzt verifiziert

1. Mai 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • SE 1-16

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

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