Epidural Analgesia in Intensive Care Unit (APD-REA: Analgesie PeriDurale en REAnimation)
| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | August 30, 2011 | ||||||||||||||||
| Last Updated Date | February 27, 2012 | ||||||||||||||||
| Start Date ICMJE | August 2011 | ||||||||||||||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Incidence of epidural analgesia-related complications [ Time Frame: up to 1 month ] [ Designated as safety issue: No ] | ||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT01437358 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Epidural Analgesia in Intensive Care Unit (APD-REA: Analgesie PeriDurale en REAnimation) | ||||||||||||||||
| Official Title ICMJE | Epidural Analgesia in Intensive Care Unit Patients: an Observational Prospective Multicenter Feasibility and Safety Study | ||||||||||||||||
| Brief Summary | Epidural analgesia (EA) has been mainly investigated during the perioperative period. In the intensive care unit settings, EA should be proposed in critically ill patients, such as postoperative or trauma patients, typically. Recent findings also support anti-inflammatory, vascular or respiratory effects for EA, beyond its analgesic effects. However, data on EA safety and feasibility in the intensive care unit settings are still lacking. The purpose of this observational prospective study is to describe the safety and feasibility of this analgesia technique in ICU patients. |
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| Detailed Description | BACKGROUND: Epidural analgesia (EA) has been mainly investigated during the perioperative period. In the intensive care unit settings, EA should be proposed in critically ill patients, such as postoperative or trauma patients, typically. Recent findings also support anti-inflammatory, vascular or respiratory effects for EA, beyond its analgesic effects. However, data on EA safety and feasibility in the intensive care unit settings are still lacking. DESIGN NARRATIVE: This observational multicenter prospective clinical study will report the incidence of EA-related complications, such as infectious or neurologic complications, and the mean duration of EA in the ICU settings. Patients admitted in three intensive care units (two from an University Hospital and one from a local hospital) and receiving EA will be included in the study, whether the EA catheter is inserted in the ICU or outside the ICU, e.g. in the operating room. Demographics, clinical and biological data will be recorded prospectively. The main goal is to evaluate the safety and feasibility of EA in critically ill patients, being assumed this technique is currently and routinely used in our intensive care units, in accordance with national and international guidelines on epidural analgesia practice. |
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| Study Type ICMJE | Observational | ||||||||||||||||
| Study Design ICMJE | Time Perspective: Cross-Sectional | ||||||||||||||||
| Target Follow-Up Duration | Not Provided | ||||||||||||||||
| Biospecimen | Not Provided | ||||||||||||||||
| Sampling Method | Non-Probability Sample | ||||||||||||||||
| Study Population | patients requiring epidural analgesia, whether the epidural analgesia catheter is inserted in the ICU or outside the ICU, e.g. in the operating room |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Epidural analgesia
The purpose of this observational prospective study is to describe the safety and feasibility of this analgesia technique in ICU patients |
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| Study Group/Cohort (s) | intensive care unit
Intervention: Other: Epidural analgesia |
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| Publications * | Not Provided | ||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||
| Enrollment ICMJE | 80 | ||||||||||||||||
| Completion Date | January 2012 | ||||||||||||||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||
| Ages | 18 Years to 95 Years | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | France | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT01437358 | ||||||||||||||||
| Other Study ID Numbers ICMJE | CHU-0100 | ||||||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||||||
| Responsible Party | University Hospital, Clermont-Ferrand | ||||||||||||||||
| Study Sponsor ICMJE | University Hospital, Clermont-Ferrand | ||||||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University Hospital, Clermont-Ferrand | ||||||||||||||||
| Verification Date | February 2012 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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