Dexmedetomidine Hydrochloride in the Prevention of Organ Failure Following Severe Acute Pancreatitis
DHPOFFSAP
1 other identifier
interventional
314
1 country
1
Brief Summary
Cytokines such as such as TNF-a, IL-1, IL-6 correlate with the severity of pancreatitis.Neuroendocrine pathways, such as the sympathetic nervous system or parasympathetic nervous system, in turn, have some impact on the immune systems, through a-2 adrenoreceptor stimulation or the cholinergic anti-inflammatory pathway. The investigators aim to use Dexmedetomidine Hydrochloride to decrease the activity of sympathetic nervous system, thus relieve inflammation response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2016
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
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 14, 2016
CompletedFirst Posted
Study publicly available on registry
February 25, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedFebruary 25, 2016
February 1, 2016
Same day
February 14, 2016
February 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence rate of Organ failure
30 days after Incidence of the disease
Secondary Outcomes (1)
Infected pancreatic necrosis
30 days after Incidence of the disease
Study Arms (2)
Group A
EXPERIMENTALDexmedetomidine Hydrochloride 4ug/ml；0.05ml/kg.h infusion for 24hours
Group B
PLACEBO COMPARATORNormal Saline 0.05ml/kg.h infusion for 24hours
Interventions
Dexmedetomidine Hydrochloride or normal saline 4ug/ml；0.05ml/kg.h infusion for 24hours
Eligibility Criteria
You may qualify if:
- Patients diagnosed with severe acute pancreatitis within 48h
- APACHE II≥8
- Patients or the family agreed to receive the treatment, and signed the informed consents
You may not qualify if:
- Patients were allergy to the drug
- Patients were diagnosed with Arrhythmia
- Patients with artificial permanent pacemaker implantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China
Nanjing, Jiangsu, 210002, China
Related Publications (1)
Zhang L, Zhou J, Ke L, Nie Y, Tong Z, Li W, Li J. Role of heart rate variability in predicting the severity of severe acute pancreatitis. Dig Dis Sci. 2014 Oct;59(10):2557-64. doi: 10.1007/s10620-014-3192-5. Epub 2014 May 13.
PMID: 24821463RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Weiqin Li, M.D.
Jinling Hospital, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
February 14, 2016
First Posted
February 25, 2016
Study Start
February 1, 2016
Primary Completion
February 1, 2016
Study Completion
August 1, 2017
Last Updated
February 25, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will share