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Dexmedetomidine Hydrochloride in the Prevention of Organ Failure Following Severe Acute Pancreatitis (DHPOFFSAP)

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ClinicalTrials.gov Identifier: NCT02691598
Recruitment Status : Unknown
Verified February 2016 by Weiqin Li, Nanjing University School of Medicine.
Recruitment status was:  Not yet recruiting
First Posted : February 25, 2016
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
Weiqin Li, Nanjing University School of Medicine

Tracking Information
First Submitted Date  ICMJE February 14, 2016
First Posted Date  ICMJE February 25, 2016
Last Update Posted Date February 25, 2016
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2016)
Incidence rate of Organ failure [ Time Frame: 30 days after Incidence of the disease ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2016)
Infected pancreatic necrosis [ Time Frame: 30 days after Incidence of the disease ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine Hydrochloride in the Prevention of Organ Failure Following Severe Acute Pancreatitis
Official Title  ICMJE Dexmedetomidine Hydrochloride in the Prevention of Organ Failure Following
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.
Detailed Description

Infected pancreatic necrosis (IPN) and multiple organ dysfunction syndrome (MODS) are major complications of acute pancreatitis which determine disease severity and outcome.It is concluded that systemic inflammation in SAP characterized by the endocrine release of different cytokines, such as TNF-a, IL-1, IL-6 and many others. These cytokines 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. Dexmedetomidine Hydrochloride is a high selected a-2 adrenoreceptor agonists.Some studies have shown that Dexmedetomidine Hydrochloride could improve the outcome of sepsis patients and decrease the development of organ failure.

The investigators aim to use Dexmedetomidine Hydrochloride to decrease the activity of sympathetic nervous system,thus relieve inflammation response.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pancreatitis, Acute Necrotizing
Intervention  ICMJE Drug: Infusion
Dexmedetomidine Hydrochloride or normal saline 4ug/ml;0.05ml/kg.h infusion for 24hours
Other Name: yan suan you meituo mi ding zhu she ye
Study Arms  ICMJE
  • Experimental: Group A
    Dexmedetomidine Hydrochloride 4ug/ml;0.05ml/kg.h infusion for 24hours
    Intervention: Drug: Infusion
  • Placebo Comparator: Group B
    Normal Saline 0.05ml/kg.h infusion for 24hours
    Intervention: Drug: Infusion
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 20, 2016)
314
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2017
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients were allergy to the drug
  • Patients were diagnosed with Arrhythmia
  • Patients with artificial permanent pacemaker implantation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02691598
Other Study ID Numbers  ICMJE DHPOFFSAP1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Weiqin Li, Nanjing University School of Medicine
Study Sponsor  ICMJE Nanjing University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Weiqin Li, M.D. Jinling Hospital, China
PRS Account Nanjing University School of Medicine
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP