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

February 20, 2016 updated by: Weiqin Li, Nanjing University School of Medicine

Dexmedetomidine Hydrochloride in the Prevention of Organ Failure Following

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

314

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • yan suan you meituo mi ding zhu she ye

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing University School of Medicine

Investigators

  • Study Director: Weiqin Li, M.D., Jinling Hospital, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

February 14, 2016

First Submitted That Met QC Criteria

February 20, 2016

First Posted (Estimate)

February 25, 2016

Study Record Updates

Last Update Posted (Estimate)

February 25, 2016

Last Update Submitted That Met QC Criteria

February 20, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHPOFFSAP1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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