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

Dexmedetomidine Hydrochloride in the Prevention of Organ Failure Following

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02691598
Acronym
DHPOFFSAP
Enrollment
314
Registered
2016-02-25
Start date
2016-02-29
Completion date
2017-08-31
Last updated
2016-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatitis, Acute Necrotizing

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.

Interventions

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

Sponsors

Nanjing University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence rate of Organ failure30 days after Incidence of the disease

Secondary

MeasureTime frame
Infected pancreatic necrosis30 days after Incidence of the disease

Countries

China

Contacts

Primary ContactWeiqin Li, M.D.
liweiqindr@vip.163.com+8613182810702

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026