Critical IllnessNCT00466492
Advantages and Disadvantages of Long Term Sedation in Intensive Care Unit Patients
A study testing Sedation or no sedation during mechanical ventilation in people with Critical Illness and Length of Stay, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The purpose of the study is to determine whether sedation of the critical ill patient prolongs the time receiving mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Length of Stay, Respiration, Artificial
- What is being tested?
- Sedation or no sedation during mechanical ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2007to May 2009
- Phase
- Interventional
- 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
Who may be able to join
- Intubated receiving mechanical ventilation
- Expected to remain intubated more than 24 hours
- Over 18 years
Who cannot join
- Raised intracranial pressure
- Pregnant
- Treatment with muscle relaxants
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Anaesthesiologic-intensive Care Department, Odense University Hospital
Odense C, Odense C, 5000
About this study
Official title: Advantages and Disadvantages of Long Term Sedation in ICU Patients
The purpose of the study is to determine whether sedation of the critical ill patient prolongs the time receiving mechanical ventilation.
Read the detailed description
The golden standard is to sedate critical ill patients receiving mechanical ventilation with daily wake up trials. This is shown to reduce the time receiving mechanical ventilation compared to no wake up trials.
We would like to study whether no sedation but only analgesics administered as bolus doses, reduce the time receiving mechanical ventilation. The study is planned as a randomised prospective study, not blinded. The control group is patients receiving sedation with daily wake up trials. The intervention group is not sedated, but receives bolus doses of analgesics (morphine). The endpoint is the time spend receiving mechanical ventilation, lengths of stay on the intensive care unit, and total lengths of stay on the hospital.
We also examine the frequency of ventilator associated pneumonia and CT scans of cerebrum. Also we would like to examine the long term psychological effects of sedation, we plan to send some of the patients to a post traumatic stress screening. The effect on the next of kin we plan to study with a questionnaire. As a last thing we would like to study the workload on the nurses.
- Being tested
- Sedation or no sedation during mechanical ventilation
- Keywords
- Drug Administration Schedule, Intensive Care Units, Length of Stay, Respiration, Artificial, Stress Disorders, Post-Traumatic/etiology/*psychology, Critical Illness/*psychology, Pneumonia/prevention & control, Hypnotics and Sedatives/*administration & dosage
- Medical subject headings
- Critical Illness, Respiratory Aspiration, Stress Disorders, Traumatic, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation or no sedation during mechanical ventilationProcedure or surgery
Also called Awake, intensive care, Denmark, Mechanical ventilation
No sedation to critically ill patients
| Study group | Role | What they receive |
|---|---|---|
| No sedatation intervention | Other | The intervention group is the normal care in our institution, the control group is the golden standard Receives: Procedure: Sedation or no sedation during mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time receiving mechanical ventilation, total intensive care and hospital length of stay.
Secondary outcomes (1)
The frequency of VAP, CTC. The amount of Post Traumatic Stress after 6 month. The patients families experience. The workload on the nurses
Measured: VAP and CTC during hospital stay. PTSD 1-2 years after the primary stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 Odense 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Palle Toft, Professor, Study chair, Institute of Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466492
- Sponsor's protocol ID
- 22-6-06
- Status last verified
- Jun 2009
- First submitted
- 26 Apr 2007
- Last updated
- 19 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.
PubMed 10816184Kress JP, Gehlbach B, Lacy M, Pliskin N, Pohlman AS, Hall JB. The long-term psychological effects of daily sedative interruption on critically ill patients. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1457-61. doi: 10.1164/rccm.200303-455OC. Epub 2003 Oct 2.
PubMed 14525802Schweickert WD, Gehlbach BK, Pohlman AS, Hall JB, Kress JP. Daily interruption of sedative infusions and complications of critical illness in mechanically ventilated patients. Crit Care Med. 2004 Jun;32(6):1272-6. doi: 10.1097/01.ccm.0000127263.54807.79.
PubMed 15187505Strom T, Stylsvig M, Toft P. Long-term psychological effects of a no-sedation protocol in critically ill patients. Crit Care. 2011;15(6):R293. doi: 10.1186/cc10586. Epub 2011 Dec 13.
PubMed 22166673Strom T, Johansen RR, Prahl JO, Toft P. Sedation and renal impairment in critically ill patients: a post hoc analysis of a randomized trial. Crit Care. 2011;15(3):R119. doi: 10.1186/cc10218. Epub 2011 May 4.
PubMed 21542927Strom T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. Lancet. 2010 Feb 6;375(9713):475-80. doi: 10.1016/S0140-6736(09)62072-9. Epub 2010 Jan 29.
PubMed 20116842
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advantages and Disadvantages of Long Term Sedation in ICU Patients
- ClinicalTrials.gov ID
- NCT00466492
- Acronym / sponsor ID
- 22-6-06
- Keywords
- Drug Administration Schedule, Intensive Care Units, Length of Stay, Respiration, Artificial, Stress Disorders, Post-Traumatic/etiology/*psychology, Critical Illness/*psychology, Pneumonia/prevention & control, Hypnotics and Sedatives/*administration & dosage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 27 Apr 2007 (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.
The purpose of the study is to determine whether sedation of the critical ill patient prolongs the time receiving mechanical ventilation.
Detailed description
The golden standard is to sedate critical ill patients receiving mechanical ventilation with daily wake up trials. This is shown to reduce the time receiving mechanical ventilation compared to no wake up trials.
We would like to study whether no sedation but only analgesics administered as bolus doses, reduce the time receiving mechanical ventilation. The study is planned as a randomised prospective study, not blinded. The control group is patients receiving sedation with daily wake up trials. The intervention group is not sedated, but receives bolus doses of analgesics (morphine). The endpoint is the time spend receiving mechanical ventilation, lengths of stay on the intensive care unit, and total lengths of stay on the hospital.
We also examine the frequency of ventilator associated pneumonia and CT scans of cerebrum. Also we would like to examine the long term psychological effects of sedation, we plan to send some of the patients to a post traumatic stress screening. The effect on the next of kin we plan to study with a questionnaire. As a last thing we would like to study the workload on the nurses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No sedatation intervention | Other | Procedure: Sedation or no sedation during mechanical ventilationThe intervention group is the normal care in our institution, the control group is the golden standard |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Intubated receiving mechanical ventilation
- Expected to remain intubated more than 24 hours
- Over 18 years
Key exclusion criteria (3 listed)
- Raised intracranial pressure
- Pregnant
- Treatment with muscle relaxants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedation or no sedation during mechanical ventilationAlso: Awake, intensive care, Denmark, Mechanical ventilationNo sedation to critically ill patients | Procedure or surgery | No sedatation intervention |
Primary outcome
Time receiving mechanical ventilation, total intensive care and hospital length of stay.
1 secondary outcome
The frequency of VAP, CTC. The amount of Post Traumatic Stress after 6 month. The patients families experience. The workload on the nurses
Time frame: VAP and CTC during hospital stay. PTSD 1-2 years after the primary stay
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 19 Mar 2010.
- Results publication: PubMed 10816184Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.
- Results publication: PubMed 14525802Kress JP, Gehlbach B, Lacy M, Pliskin N, Pohlman AS, Hall JB. The long-term psychological effects of daily sedative interruption on critically ill patients. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1457-61. doi: 10.1164/rccm.200303-455OC. Epub 2003 Oct 2.
- Results publication: PubMed 15187505Schweickert WD, Gehlbach BK, Pohlman AS, Hall JB, Kress JP. Daily interruption of sedative infusions and complications of critical illness in mechanically ventilated patients. Crit Care Med. 2004 Jun;32(6):1272-6. doi: 10.1097/01.ccm.0000127263.54807.79.
- Derived from this study: PubMed 22166673Strom T, Stylsvig M, Toft P. Long-term psychological effects of a no-sedation protocol in critically ill patients. Crit Care. 2011;15(6):R293. doi: 10.1186/cc10586. Epub 2011 Dec 13.
- Derived from this study: PubMed 21542927Strom T, Johansen RR, Prahl JO, Toft P. Sedation and renal impairment in critically ill patients: a post hoc analysis of a randomized trial. Crit Care. 2011;15(3):R119. doi: 10.1186/cc10218. Epub 2011 May 4.
- Derived from this study: PubMed 20116842Strom T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. Lancet. 2010 Feb 6;375(9713):475-80. doi: 10.1016/S0140-6736(09)62072-9. Epub 2010 Jan 29.
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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.
Palle Toft, Professor study chair
Institute of Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedation or no sedation during mechanical ventilation in people with Critical Illness and Length of Stay, run by Odense 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 3 inclusion and 3 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 19 Mar 2010. 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?
Time receiving mechanical ventilation, total intensive care and hospital length of stay.. 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 NCT00466492, 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 19 Mar 2010.