NCT02279212

Brief Summary

Previous research on intensive care unit (ICU) survivors shows that rehabilitation is challenging, because of patients experiences of disease related problems both under and after treatment. Approximately 20 % of patients die within hospital, up to 80% suffer from hallucinations and nightmares, deal with paranoiac experiences, chronic pain and other symptoms and disability (Angus et al 2004; De Letter et al 2001; Ely et al 2001; Nelson et al 2006; Van den Berghe et al 2001; Van den Berghe et al 2003) . A recent study shows that 28% of intensive care survivors have chronic pain that reduce their health related quality of life (Boyle et al 2004). The aim of this study is to perform a survey about prevalence of pain type, and which consequences this causes when it comes to function and quality of life up to 12 months after the ICU stay.

  1. 1.What type of pain has ICU survivors and how do pain change over time, related to treatment/rehabilitation and the illness' development?
  2. 2.What is the relationship between different pain characteristic, quality of life, anxiety, depression, fatigue, sleep and PTSD in these patients?
  3. 3.What is these patients largest obstacle for good QoL after discharge from hospital?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2010

Completed
3.9 years until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2018

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

8 years

First QC Date

December 6, 2010

Last Update Submit

March 3, 2020

Conditions

Keywords

Critical illnesspainquality of life

Outcome Measures

Primary Outcomes (1)

  • Do pain change over time in ICU survivors meassured with BPI and NPSI?

    We will compare the results from 3 months with 1 year and look for differences.

    1year after ICU discharge

Secondary Outcomes (4)

  • What is the relationship between patients self reported experience of pain and neurophysiological findings?

    3 months after ICU discharge

  • What is the relationship between patients self reported experience of pain and neurophysiological findings?

    1 year after ICU discharge

  • How are ICU survivors health related quality of life meassured with SF12?

    3 months after ICU discharge

  • How are ICU survivors health related quality of life meassured with SF 12?

    1 year after ICU discharge

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients in a Norwegian ICU. Medical and surgical patients, no thorasic surgery or trauma.

You may qualify if:

  • ICU stay longer than 48 h
  • years old or older
  • Patients must write and understand Norwegian well.

You may not qualify if:

  • Dying patients
  • No acceptance form next of kind
  • No concent from the patients
  • Other that the researcher thinks should be excluded f. ex Patients with very bad prognosis
  • Patients with low probability for self report after ICU stay

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

Related Publications (1)

  • Langerud AK, Rustoen T, Smastuen MC, Kongsgaard U, Stubhaug A. Intensive care survivor-reported symptoms: a longitudinal study of survivors' symptoms. Nurs Crit Care. 2018 Jan;23(1):48-54. doi: 10.1111/nicc.12330. Epub 2017 Dec 15.

MeSH Terms

Conditions

Critical IllnessPain

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Audun Stubhaug, MD PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MNSc

Study Record Dates

First Submitted

December 6, 2010

First Posted

October 31, 2014

Study Start

May 1, 2010

Primary Completion

April 30, 2018

Study Completion

September 6, 2018

Last Updated

March 4, 2020

Record last verified: 2020-03

Locations