Pancreatitis, Acute NecrotizingPhase 4DHPOFFSAPNCT02691598
Dexmedetomidine Hydrochloride in the Prevention of Organ Failure Following Severe Acute Pancreatitis
A Phase 4 study testing Infusion in people with Pancreatitis, Acute Necrotizing, run by Nanjing University School of Medicine at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Pancreatitis, Acute Necrotizing
- What is being tested?
- Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 314 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients were allergy to the drug
- Patients were diagnosed with Arrhythmia
- Patients with artificial permanent pacemaker implantation
Trial locations and contacts
1 site in 1 country.
China1 site
Department of SICU, Research Institute of General Surgery Jinling Hospital, Nanjing, Jiangsu, China
Nanjing, Jiangsu, 210002
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatitis, Acute Necrotizing
- Being tested
- Infusion
- Medical subject headings
- Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfusionDrug
Also called yan suan you meituo mi ding zhu she ye
Dexmedetomidine Hydrochloride or normal saline 4ug/ml；0.05ml/kg.h infusion for 24hours
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Dexmedetomidine Hydrochloride 4ug/ml；0.05ml/kg.h infusion for 24hours Receives: Drug: Infusion |
| Group B | Placebo comparator | Normal Saline 0.05ml/kg.h infusion for 24hours Receives: Drug: Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of Organ failure
Measured: 30 days after Incidence of the disease
Secondary outcomes (1)
Infected pancreatic necrosis
Measured: 30 days after Incidence of the disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2016 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatitis, Acute NecrotizingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiqin Li, Nanjing University School of Medicine
- Investigators
- Weiqin Li, M.D., Study director, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691598
- Sponsor's protocol ID
- DHPOFFSAP1
- Acronym
- DHPOFFSAP
- Status last verified
- Feb 2016
- First submitted
- 14 Feb 2016
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 24821463
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Hydrochloride in the Prevention of Organ Failure Following
- ClinicalTrials.gov ID
- NCT02691598
- Acronym / sponsor ID
- DHPOFFSAP / DHPOFFSAP1
- Conditions
- Pancreatitis, Acute Necrotizing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Nanjing University School of MedicineUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: InfusionDexmedetomidine Hydrochloride 4ug/ml；0.05ml/kg.h infusion for 24hours |
| Group B | Placebo comparator | Drug: InfusionNormal Saline 0.05ml/kg.h infusion for 24hours |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients were allergy to the drug
- Patients were diagnosed with Arrhythmia
- Patients with artificial permanent pacemaker implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfusionAlso: yan suan you meituo mi ding zhu she yeDexmedetomidine Hydrochloride or normal saline 4ug/ml；0.05ml/kg.h infusion for 24hours | Drug | Group A, Group B |
Primary outcome
Incidence rate of Organ failure
Time frame: 30 days after Incidence of the disease
1 secondary outcome
Infected pancreatic necrosis
Time frame: 30 days after Incidence of the disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
- Results publication: PubMed 24821463Zhang 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weiqin Li, M.D. study director
Jinling Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infusion in people with Pancreatitis, Acute Necrotizing, run by Nanjing University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiqin Li, M.D. (+8613182810702, liweiqindr@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of Organ failure (time frame: 30 days after Incidence of the disease). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02691598, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2016.