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

Systemic Inflammatory Response Syndrome Clinical Trial

Official title:

The Prevention and Treatment of SIRS in Patients With Cholestatic Jaundice After Operation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02279147
• Other study ID #: CHN-PLAGH-WGu-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: September 22, 2014
• Last updated: October 28, 2014
• Start date: August 2014
• Est. completion date: September 2017

Study information

• Verified date: October 2014
• Source: Chinese PLA General Hospital
• Contact: Wanqing GU, MD
• Phone: +86-10-66938334
• Email: 13366779198[@]163.com
• Is FDA regulated: No
• Health authority: China:Ethics Committee of Chinese PLA General Hospital
• Study type: Interventional

Clinical 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

?.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.

?. Drugs which were used in the clinical trials is safe for patients.

?.The patients did not occur the complication which would affect the experimental observation seriously after the operation.

?.The patients agreed to participate in this clinical trial and sign the informed consent.

Exclusion Criteria:

?.Patients are unwilling to accept the clinical trials or researchers believe that patients can not in compliance with the requirements of clinical research.

?.Patients with tumor metastases widely or can not accept a predetermined operation scheme.

?. The postoperative complications or other therapeutic measures take will affect the experimental observation seriously.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Jaundice
• Jaundice, Obstructive
• Systemic Inflammatory Response Syndrome

Intervention

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.

Locations

Country	Name	City	State
China	CHN Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Wanqing Gu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C reactive protein	Indicator of the stress level.	One year	No
Secondary	Temperature	Indicator of systemic inflammatory response syndrome.	One year	No
Secondary	Heart rate	Indicator of systemic inflammatory response syndrome.	One year	No
Secondary	Respiratory	Indicator of systemic inflammatory response syndrome.	One year	No
Secondary	PaCO2	Indicator of systemic inflammatory response syndrome.	One year	No
Secondary	White blood cell count	Indicator of systemic inflammatory response syndrome.	one year	No
Secondary	Alanine aminotransferase(ALT)	Indicators of liver function.	One year	No
Secondary	Aspartate aminotransferase(AST)	Indicators of liver function.	One year	No
Secondary	Total bilirubin	Indicators of liver function.	One year	No
Secondary	Interleukin 1(IL-1)	Indicators of pro-inflammatory mediators	One year	No
Secondary	Interleukin 2(IL-2)	Pro-inflammatory mediators.	One year	No
Secondary	Interleukin 6(IL-6)	Pro-inflammatory mediators.	One year	No
Secondary	Interleukin 8( IL-8)	Pro-inflammatory mediators	One year	No
Secondary	Tumor necrosis factor-a	Pro-inflammatory mediators.	One year	No
Secondary	Interleukin 10( IL-10)	Anti-inflammatory mediators	One year	No
Secondary	Triiodothyronine(T3) & Thyroxin(T4) & Thyroid stimulating hormone(TSH)	Indicators of the stress level.	One year	No