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

Pancreatitis, Acute Necrotizing Clinical Trial

— DHPOFFSAP  

Official title:

Dexmedetomidine Hydrochloride in the Prevention of Organ Failure Following

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02691598
• Other study ID #: DHPOFFSAP1
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 14, 2016
• Last updated: February 20, 2016
• Start date: February 2016
• Est. completion date: August 2017

Study information

• Verified date: February 2016
• Source: Nanjing University School of Medicine
• Contact: Weiqin Li, M.D.
• Phone: +8613182810702
• Email: liweiqindr[@]vip.163.com
• Is FDA regulated: No
• Health authority: China: Chinese Medical Association
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 314
• Est. completion date: August 2017
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Acute Necrotizing

Intervention

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

Locations

Country	Name	City	State
China	Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of Organ failure		30 days after Incidence of the disease	Yes
Secondary	Infected pancreatic necrosis		30 days after Incidence of the disease	Yes