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Cholinergic Anti-inflammatory Pathway in Prevention & Treatment of the SIRS in Patients With Jaundice After Operation.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02279147
Recruitment Status : Unknown
Verified October 2014 by Wanqing Gu, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : October 30, 2014
Last Update Posted : October 30, 2014
Sponsor:
Information provided by (Responsible Party):
Wanqing Gu, Chinese PLA General Hospital

Brief 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 .


Condition or disease Intervention/treatment Phase
Systemic Inflammatory Response Syndrome Jaundice, Obstructive Drug: neostigmine methylsulfate,raceanisodamine hydrochloride Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Prevention and Treatment of SIRS in Patients With Cholestatic Jaundice After Operation.
Study Start Date : August 2014
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: raceanisodamine & neostigmine
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.
Drug: neostigmine methylsulfate,raceanisodamine hydrochloride
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.

No Intervention: blank
Patients do not receive special treatment after operation.



Primary Outcome Measures :
  1. C reactive protein [ Time Frame: One year ]
    Indicator of the stress level.


Secondary Outcome Measures :
  1. Temperature [ Time Frame: One year ]
    Indicator of systemic inflammatory response syndrome.

  2. Heart rate [ Time Frame: One year ]
    Indicator of systemic inflammatory response syndrome.

  3. Respiratory [ Time Frame: One year ]
    Indicator of systemic inflammatory response syndrome.

  4. PaCO2 [ Time Frame: One year ]
    Indicator of systemic inflammatory response syndrome.

  5. White blood cell count [ Time Frame: one year ]
    Indicator of systemic inflammatory response syndrome.

  6. Alanine aminotransferase(ALT) [ Time Frame: One year ]
    Indicators of liver function.

  7. Aspartate aminotransferase(AST) [ Time Frame: One year ]
    Indicators of liver function.

  8. Total bilirubin [ Time Frame: One year ]
    Indicators of liver function.

  9. Interleukin 1(IL-1) [ Time Frame: One year ]
    Indicators of pro-inflammatory mediators

  10. Interleukin 2(IL-2) [ Time Frame: One year ]
    Pro-inflammatory mediators.

  11. Interleukin 6(IL-6) [ Time Frame: One year ]
    Pro-inflammatory mediators.

  12. Interleukin 8( IL-8) [ Time Frame: One year ]
    Pro-inflammatory mediators

  13. Tumor necrosis factor-α [ Time Frame: One year ]
    Pro-inflammatory mediators.

  14. Interleukin 10( IL-10) [ Time Frame: One year ]
    Anti-inflammatory mediators

  15. Triiodothyronine(T3) & Thyroxin(T4) & Thyroid stimulating hormone(TSH) [ Time Frame: One year ]
    Indicators of the stress level.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279147


Contacts
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Contact: Wanqing GU, MD +86-10-66938334 13366779198@163.com
Contact: Yurong LIANG, MD +86-10-66938334 yurongliang@hotmail.com

Locations
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China, Beijing
CHN Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Principal Investigator: GU wanqing         
Sponsors and Collaborators
Wanqing Gu
Investigators
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Study Chair: GU wanqing CHN Chinese PLA General Hospital

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Responsible Party: Wanqing Gu, The Prevention and Treatment of SIRS in Patients With Cholestatic Jaundice After Operation., Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02279147    
Other Study ID Numbers: CHN-PLAGH-WGu-001
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: October 30, 2014
Last Verified: October 2014
Keywords provided by Wanqing Gu, Chinese PLA General Hospital:
Systemic Inflammatory Response Syndrome
Jaundice, Obstructive
anti-inflammatory
Additional relevant MeSH terms:
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Jaundice
Systemic Inflammatory Response Syndrome
Jaundice, Obstructive
Pathologic Processes
Hyperbilirubinemia
Skin Manifestations
Signs and Symptoms
Inflammation
Shock
Anti-Inflammatory Agents
Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents