Critical IllnessNEUPAQNCT02279212
Neuropathic Pain and Quality of Life in ICU Survivors
An observational study of Critical Illness, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Illness
- How many people
- 127 participants
- Where
- 1 siteNorway
- Study dates
- May 2010to 6 Sep 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients in a Norwegian ICU. Medical and surgical patients, no thorasic surgery or trauma.
Who may be able to join
- ICU stay longer than 48 h
- 18 years old or older
- Patients must write and understand Norwegian well.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- What type of pain has ICU survivors and how do pain change over time, related to treatment/rehabilitation and the illness' development?
- What is the relationship between different pain characteristic, quality of life, anxiety, depression, fatigue, sleep and PTSD in these patients?
- What is these patients largest obstacle for good QoL after discharge from hospital?
Read the detailed description
A prospective and longitudinal survey 3 time points for data collection:
- ICU - background data about the patients ICU stay (days on ventilator, medication, treatment, SAPS II, SOFA etc).
- 3 months after ICU discharge - survey about pain, QoL, sleep, fatigue, Post traumatic stress disorder (PTSD), anxiety and depression.
- One year after ICU discharge - the same as 3 months.
Survey instruments:
Pain - Brief Pain Inventory, Neuropathic Pain Syndrome Inventory, Pain diary QoL - SF 12, Sleep - General Sleep Disorder Scale Fatigue - Lee Fatigue Scale Anxiety and depression - Hospital Anxiety and Depression Scale PTSD - PTSS 10 Social Provision - Revised Social Provision Scale
- Conditions
- Critical Illness
- Keywords
- Critical illness, pain, quality of life
- Medical subject headings
- Critical Illness, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1year after ICU discharge
Secondary outcomes (4)
What is the relationship between patients self reported experience of pain and neurophysiological findings?
Measured: 3 months after ICU discharge
What is the relationship between patients self reported experience of pain and neurophysiological findings?
Measured: 1 year after ICU discharge
How are ICU survivors health related quality of life meassured with SF12?
Measured: 3 months after ICU discharge
How are ICU survivors health related quality of life meassured with SF 12?
Measured: 1 year after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startMay 2010
- Primary completion30 Apr 2018
- Study completion6 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Kathrine Langerud, Oslo University Hospital
- Investigators
- Audun Stubhaug, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279212
- Sponsor's protocol ID
- S-07505b (REK)
- Acronym
- NEUPAQ
- Status last verified
- Mar 2020
- First submitted
- 6 Dec 2010
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29243344
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropathic Pain and Quality of Life in ICU Survivors
- ClinicalTrials.gov ID
- NCT02279212
- Acronym / sponsor ID
- NEUPAQ / S-07505b (REK)
- Conditions
- Critical Illness
- Keywords
- Critical illness, pain, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 6 Sep 2018 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- What type of pain has ICU survivors and how do pain change over time, related to treatment/rehabilitation and the illness' development?
- What is the relationship between different pain characteristic, quality of life, anxiety, depression, fatigue, sleep and PTSD in these patients?
- What is these patients largest obstacle for good QoL after discharge from hospital?
Detailed description
A prospective and longitudinal survey 3 time points for data collection:
- ICU - background data about the patients ICU stay (days on ventilator, medication, treatment, SAPS II, SOFA etc).
- 3 months after ICU discharge - survey about pain, QoL, sleep, fatigue, Post traumatic stress disorder (PTSD), anxiety and depression.
- One year after ICU discharge - the same as 3 months.
Survey instruments:
Pain - Brief Pain Inventory, Neuropathic Pain Syndrome Inventory, Pain diary QoL - SF 12, Sleep - General Sleep Disorder Scale Fatigue - Lee Fatigue Scale Anxiety and depression - Hospital Anxiety and Depression Scale PTSD - PTSS 10 Social Provision - Revised Social Provision Scale
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients in a Norwegian ICU. Medical and surgical patients, no thorasic surgery or trauma.
Key inclusion criteria (3 listed)
- ICU stay longer than 48 h
- 18 years old or older
- Patients must write and understand Norwegian well.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Do pain change over time in ICU survivors meassured with BPI and NPSI?
Time frame: 1year after ICU discharge
We will compare the results from 3 months with 1 year and look for differences.
4 secondary outcomes
What is the relationship between patients self reported experience of pain and neurophysiological findings?
Time frame: 3 months after ICU discharge
What is the relationship between patients self reported experience of pain and neurophysiological findings?
Time frame: 1 year after ICU discharge
How are ICU survivors health related quality of life meassured with SF12?
Time frame: 3 months after ICU discharge
How are ICU survivors health related quality of life meassured with SF 12?
Time frame: 1 year after ICU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Derived from this study: PubMed 29243344Langerud 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audun Stubhaug, MD PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Oslo University Hospital at 1 site in Norway.
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 3 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 4 Mar 2020. 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 Norway. 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?
Do pain change over time in ICU survivors meassured with BPI and NPSI? (time frame: 1year after ICU 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 NCT02279212, which also lists 1 linked publication.
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 4 Mar 2020.