Effect of Epidural Anesthesia on Pancreatic Perfusion and Clinical Outcome in Patients With Severe Acute Pancreatitis
Phase 1 Study of Epidural Anesthesia on Pancreatic Perfusion and Clinical Outcome in Patients With Severe Acute Pancreatitis
1 other identifier
interventional
35
1 country
1
Brief Summary
The aim of the study is to evaluate the safety, the potential beneficial effect of epidural anesthesia on pancreatic perfusion and clinical outcome of patients with severe acute pancreatitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2005
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 22, 2012
CompletedFirst Posted
Study publicly available on registry
May 30, 2012
CompletedMay 30, 2012
May 1, 2012
5.1 years
May 22, 2012
May 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of patients with adverse events related to epidural anesthesia
Adverse events related to epidural anesthesia include hypotensive episodes or infection of the catheter
Participants will be followed for the duration of hospital stay, an expected average of 2 to 5 weeks
Pancreatic perfusion measured by computerized tomography
On day 0 and day 2 or 3 after hospital admission
Secondary Outcomes (1)
Clinical outcome
Participants will be followed for the duration of hospital stay, an expected average of 2 to 5 weeks
Study Arms (2)
Patient controlled intravenous analgesia
ACTIVE COMPARATORFentanyl (10 microg/ml) continuous intravenous infusion at a rate of 10 to 20 microg/h
Epidural anesthesia
EXPERIMENTALCarbostesin (0.1%) and Fentanyl (2 microg/ml) at a continuous flow of 6 to 15 ml/hour
Interventions
Epidural will be performed using carbostesin (0.1%), fentanyl (2 microg/ml) administered continuously at a rate of 6 to 15 ml/hour
Fentanyl 10 microg/ml at continuous flow of 10 to 20 microg/hour
Eligibility Criteria
You may qualify if:
- Acute pancreatitis with Ranson Criteria over 2, and/or CRP over 100, and or pancreatic necrosis on CT scan
You may not qualify if:
- Coagulation disorders
- Skin infection of the vertebral region
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Geneva
Geneva, Canton of Geneva, 1211, Switzerland
Related Publications (1)
Demirag A, Pastor CM, Morel P, Jean-Christophe C, Sielenkamper AW, Guvener N, Mai G, Berney T, Frossard JL, Buhler LH. Epidural anaesthesia restores pancreatic microcirculation and decreases the severity of acute pancreatitis. World J Gastroenterol. 2006 Feb 14;12(6):915-20. doi: 10.3748/wjg.v12.i6.915.
PMID: 16521220BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 22, 2012
First Posted
May 30, 2012
Study Start
July 1, 2005
Primary Completion
August 1, 2010
Study Completion
November 1, 2011
Last Updated
May 30, 2012
Record last verified: 2012-05