Clinical trial NCT02691598: Dexmedetomidine Hydrochloride in the Prevention of Organ Failure Following Severe Acute Pancreatitis
Official title: Dexmedetomidine Hydrochloride in the Prevention of Organ Failure Following
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pancreatitis, Acute Necrotizing
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 314
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence rate of Organ failure
timeFrame: 30 days after Incidence of the disease
Secondary outcomes:
measure: Infected pancreatic necrosis
timeFrame: 30 days after Incidence of the disease
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, China
name: Weiqin Li, M.D.
role: STUDY_DIRECTOR
References:
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.