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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

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.

Condition or disease Intervention/treatment Phase
Pancreatitis, Acute Necrotizing Drug: Infusion Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dexmedetomidine Hydrochloride in the Prevention of Organ Failure Following
Study Start Date : February 2016
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: Group A
Dexmedetomidine Hydrochloride 4ug/ml;0.05ml/kg.h infusion for 24hours
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

Placebo Comparator: Group B
Normal Saline 0.05ml/kg.h infusion for 24hours
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




Primary Outcome Measures :
  1. Incidence rate of Organ failure [ Time Frame: 30 days after Incidence of the disease ]

Secondary Outcome Measures :
  1. Infected pancreatic necrosis [ Time Frame: 30 days after Incidence of the disease ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691598


Contacts
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Contact: Weiqin Li, M.D. +8613182810702 liweiqindr@vip.163.com

Locations
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China, Jiangsu
Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Nanjing University School of Medicine
Investigators
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Study Director: Weiqin Li, M.D. Jinling Hospital, China

Publications of Results:
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Responsible Party: Weiqin Li, Dr., Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT02691598     History of Changes
Other Study ID Numbers: DHPOFFSAP1
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Acute Necrotizing
Pancreatic Diseases
Digestive System Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action