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

Nanjing University School of Medicine

Status and phase: Unknown; Phase 4

Conditions: Pancreatitis, Acute Necrotizing

Treatments: Drug: Infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT02691598

DHPOFFSAP1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 314 estimated patients

Sex: All

Ages: 15 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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314 participants in 2 patient groups, including a placebo group

Group A

Experimental group

Description:

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

Treatment:

Drug: Infusion

Group B

Placebo Comparator group

Description:

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

Treatment:

Drug: Infusion