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

Overview

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.

Full Title of Study: “Dexmedetomidine Hydrochloride in the Prevention of Organ Failure Following”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2016

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.

Interventions

  • Drug: Infusion
    • Dexmedetomidine Hydrochloride or normal saline 4ug/ml;0.05ml/kg.h infusion for 24hours

Arms, Groups and Cohorts

  • Experimental: Group A
    • Dexmedetomidine Hydrochloride 4ug/ml;0.05ml/kg.h infusion for 24hours
  • Placebo Comparator: Group B
    • Normal Saline 0.05ml/kg.h infusion for 24hours

Clinical Trial Outcome Measures

Primary Measures

  • Incidence rate of Organ failure
    • Time Frame: 30 days after Incidence of the disease

Secondary Measures

  • Infected pancreatic necrosis
    • Time Frame: 30 days after Incidence of the disease

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nanjing University School of Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Weiqin Li, Dr. – Nanjing University School of Medicine
  • Overall Official(s)
    • Weiqin Li, M.D., Study Director, Jinling Hospital, China
  • Overall Contact(s)
    • Weiqin Li, M.D., +8613182810702, liweiqindr@vip.163.com

Citations Reporting on Results

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.

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