Systemic Inflammatory Response SyndromePhase 1/2NCT02279147
Cholinergic Anti-inflammatory Pathway in Prevention & Treatment of the SIRS in Patients With Jaundice After Operation.
A Phase 1/2 study testing neostigmine methylsulfate，raceanisodamine hydrochloride in people with Systemic Inflammatory Response Syndrome and Jaundice, Obstructive, run by Wanqing Gu at 1 site in China.
Trial summary
RATIONALE:Anticholinesterase drugs and cholinergic M receptor antagonist are applied to patients who have obstructive jaundice after operation. PURPOSE:This clinical trial was designed to lower the incidence and mortality of operation complications in patients with obstructive jaundice . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Systemic Inflammatory Response Syndrome, Jaundice, Obstructive
- What is being tested?
- neostigmine methylsulfate，raceanisodamine hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Sep 2017
- Phase
- Phase 1/2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ⅰ.Accompanied by obstructive jaundice and plans to implement the liver resection of hilar bile duct carcinoma.
- Patients with carcinoma of head of pancreas and plans to implement pancreaticoduodenectomy.
- Ⅱ. Drugs which were used in the clinical trials is safe for patients.
- Ⅲ.The patients did not occur the complication which would affect the experimental observation seriously after the operation.
- Ⅳ.The patients agreed to participate in this clinical trial and sign the informed consent.
Who cannot join
- Ⅰ.Patients are unwilling to accept the clinical trials or researchers believe that patients can not in compliance with the requirements of clinical research.
- Ⅱ.Patients with tumor metastases widely or can not accept a predetermined operation scheme.
- Ⅲ. The postoperative complications or other therapeutic measures take will affect the experimental observation seriously.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
CHN Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
GU wanqing
About this study
Official title: The Prevention and Treatment of SIRS in Patients With Cholestatic Jaundice After Operation.
RATIONALE:Anticholinesterase drugs and cholinergic M receptor antagonist are applied to patients who have obstructive jaundice after operation.
PURPOSE:This clinical trial was designed to lower the incidence and mortality of operation complications in patients with obstructive jaundice .
Read the detailed description
OBJECTIVES:
Ⅰ.Judge whether it has the effect of inhibiting inflammation, anti oxidative stress and anti apoptosis when the alpha 7 nicotinic acetylcholine receptors are activated .
Ⅱ.Judge whether it has the effect of reducing the incidence and mortality of operation complication when using Cholinesterase inhibitors and M cholinergic receptor blocking agent in Patients with obstructive jaundice after operation。
OUTLINE:Patients are assigned to 1 of 2 groups according to order of enrollment.
Group 1:Patients receive neostigmine methylsulfate and raceanisodamine hydrochloride on days 0,1,2 after operation.
Group 2:Patients do not receive any special treatment after operation.
All patients should be monitored the observed indexes on the day before the operation and one day, three days, five days after the operation.
- Being tested
- neostigmine methylsulfate，raceanisodamine hydrochloride
- Keywords
- Systemic Inflammatory Response Syndrome, Jaundice, Obstructive, anti-inflammatory
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neostigmine methylsulfate，raceanisodamine hydrochlorideDrug
The patients receive immediately raceanisodamine hydrochloride(10mg) by intramuscular injection after operation .From that date, for three consecutive days, the patients will be receive 50mg raceanisodamine hydrochloride and 0.15mg neostigmine methylsulfate in the 24h by slow injection of vein.
| Study group | Role | What they receive |
|---|---|---|
| raceanisodamine & neostigmine | Experimental | Patients receive immediately raceanisodamine（10mg）by intramuscular injection after operation.Then the patients will be receive 50mg raceanisodamine and 0.15mg neostigmine within 24hs by slow injection into vein for three consecutive days. Receives: Drug: neostigmine methylsulfate，raceanisodamine hydrochloride |
| blank | No intervention | Patients do not receive special treatment after operation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
C reactive protein
Indicator of the stress level.
Measured: One year
Secondary outcomes (15)
Temperature
Indicator of systemic inflammatory response syndrome.
Measured: One year
Heart rate
Indicator of systemic inflammatory response syndrome.
Measured: One year
Respiratory
Indicator of systemic inflammatory response syndrome.
Measured: One year
PaCO2
Indicator of systemic inflammatory response syndrome.
Measured: One year
White blood cell count
Indicator of systemic inflammatory response syndrome.
Measured: one year
Alanine aminotransferase（ALT)
Indicators of liver function.
Measured: One year
Aspartate aminotransferase（AST）
Indicators of liver function.
Measured: One year
Total bilirubin
Indicators of liver function.
Measured: One year
Interleukin 1（IL-1）
Indicators of pro-inflammatory mediators
Measured: One year
Interleukin 2（IL-2）
Pro-inflammatory mediators.
Measured: One year
Interleukin 6（IL-6）
Pro-inflammatory mediators.
Measured: One year
Interleukin 8（ IL-8）
Pro-inflammatory mediators
Measured: One year
Tumor necrosis factor-α
Pro-inflammatory mediators.
Measured: One year
Interleukin 10（ IL-10）
Anti-inflammatory mediators
Measured: One year
Triiodothyronine(T3) & Thyroxin(T4) & Thyroid stimulating hormone(TSH)
Indicators of the stress level.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Inflammatory Response SyndromeStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wanqing Gu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wanqing Gu, Chinese PLA General Hospital
- Investigators
- GU wanqing, Study chair, CHN Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279147
- Sponsor's protocol ID
- CHN-PLAGH-WGu-001
- Status last verified
- Oct 2014
- First submitted
- 22 Sep 2014
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevention and Treatment of SIRS in Patients With Cholestatic Jaundice After Operation.
- ClinicalTrials.gov ID
- NCT02279147
- Acronym / sponsor ID
- CHN-PLAGH-WGu-001
- Keywords
- Systemic Inflammatory Response Syndrome, Jaundice, Obstructive, anti-inflammatory
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wanqing GuUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 30 Oct 2014 (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.
RATIONALE:Anticholinesterase drugs and cholinergic M receptor antagonist are applied to patients who have obstructive jaundice after operation.
PURPOSE:This clinical trial was designed to lower the incidence and mortality of operation complications in patients with obstructive jaundice .
Detailed description
OBJECTIVES:
Ⅰ.Judge whether it has the effect of inhibiting inflammation, anti oxidative stress and anti apoptosis when the alpha 7 nicotinic acetylcholine receptors are activated .
Ⅱ.Judge whether it has the effect of reducing the incidence and mortality of operation complication when using Cholinesterase inhibitors and M cholinergic receptor blocking agent in Patients with obstructive jaundice after operation。
OUTLINE:Patients are assigned to 1 of 2 groups according to order of enrollment.
Group 1:Patients receive neostigmine methylsulfate and raceanisodamine hydrochloride on days 0,1,2 after operation.
Group 2:Patients do not receive any special treatment after operation.
All patients should be monitored the observed indexes on the day before the operation and one day, three days, five days after the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| raceanisodamine & neostigmine | Experimental | Drug: neostigmine methylsulfate，raceanisodamine hydrochloridePatients receive immediately raceanisodamine（10mg）by intramuscular injection after operation.Then the patients will be receive 50mg raceanisodamine and 0.15mg neostigmine within 24hs by slow injection into vein for three consecutive days. |
| blank | No intervention | –Patients do not receive special treatment after operation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ⅰ.Accompanied by obstructive jaundice and plans to implement the liver resection of hilar bile duct carcinoma.
- Patients with carcinoma of head of pancreas and plans to implement pancreaticoduodenectomy.
- Ⅱ. Drugs which were used in the clinical trials is safe for patients.
- Ⅲ.The patients did not occur the complication which would affect the experimental observation seriously after the operation.
- Ⅳ.The patients agreed to participate in this clinical trial and sign the informed consent.
Key exclusion criteria (3 listed)
- Ⅰ.Patients are unwilling to accept the clinical trials or researchers believe that patients can not in compliance with the requirements of clinical research.
- Ⅱ.Patients with tumor metastases widely or can not accept a predetermined operation scheme.
- Ⅲ. The postoperative complications or other therapeutic measures take will affect the experimental observation seriously.
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 |
|---|---|---|
| neostigmine methylsulfate，raceanisodamine hydrochlorideThe patients receive immediately raceanisodamine hydrochloride(10mg) by intramuscular injection after operation .From that date, for three consecutive days, the patients will be receive 50mg raceanisodamine hydrochloride and 0.15mg neostigmine methylsulfate in the 24h by slow injection of vein. | Drug | raceanisodamine & neostigmine |
Primary outcome
C reactive protein
Time frame: One year
Indicator of the stress level.
15 secondary outcomes
Temperature
Time frame: One year
Heart rate
Time frame: One year
Respiratory
Time frame: One year
PaCO2
Time frame: One year
White blood cell count
Time frame: one year
Alanine aminotransferase（ALT)
Time frame: One year
Aspartate aminotransferase（AST）
Time frame: One year
Total bilirubin
Time frame: One year
Interleukin 1（IL-1）
Time frame: One year
Interleukin 2（IL-2）
Time frame: One year
Interleukin 6（IL-6）
Time frame: One year
Interleukin 8（ IL-8）
Time frame: One year
Tumor necrosis factor-α
Time frame: One year
Interleukin 10（ IL-10）
Time frame: One year
Triiodothyronine(T3) & Thyroxin(T4) & Thyroid stimulating hormone(TSH)
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2014.
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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.
GU wanqing study chair
CHN Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing neostigmine methylsulfate，raceanisodamine hydrochloride in people with Systemic Inflammatory Response Syndrome and Jaundice, Obstructive, run by Wanqing Gu 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 5 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 30 Oct 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Wanqing GU, MD (+86-10-66938334, 13366779198@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C reactive protein (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2014.