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

Primary Purpose

Pancreatitis, Acute Necrotizing

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Infusion
Sponsored by
Nanjing University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreatitis, Acute Necrotizing

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

Dexmedetomidine Hydrochloride 4ug/ml；0.05ml/kg.h infusion for 24hours

Normal Saline 0.05ml/kg.h infusion for 24hours

Outcomes

Primary Outcome Measures

Incidence rate of Organ failure

Secondary Outcome Measures

Infected pancreatic necrosis

Full Information

First Posted
February 14, 2016
Last Updated
February 20, 2016
Sponsor
Nanjing University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02691598
Brief Title
Dexmedetomidine Hydrochloride in the Prevention of Organ Failure Following Severe Acute Pancreatitis
Acronym
DHPOFFSAP
Official Title
Dexmedetomidine Hydrochloride in the Prevention of Organ Failure Following
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Acute Necrotizing

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
314 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Dexmedetomidine Hydrochloride 4ug/ml；0.05ml/kg.h infusion for 24hours
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
Normal Saline 0.05ml/kg.h infusion for 24hours
Intervention Type
Drug
Intervention Name(s)
Infusion
Other Intervention Name(s)
yan suan you meituo mi ding zhu she ye
Intervention Description
Dexmedetomidine Hydrochloride or normal saline 4ug/ml；0.05ml/kg.h infusion for 24hours
Primary Outcome Measure Information:
Title
Incidence rate of Organ failure
Time Frame
30 days after Incidence of the disease
Secondary Outcome Measure Information:
Title
Infected pancreatic necrosis
Time Frame
30 days after Incidence of the disease

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weiqin Li, M.D.
Phone
+8613182810702
Email
liweiqindr@vip.163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiqin Li, M.D.
Organizational Affiliation
Jinling Hospital, China
Official's Role
Study Director
Facility Information:
Facility Name
Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
24821463
Citation
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.
Results Reference
result

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

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