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

Primary Purpose

Systemic Inflammatory Response Syndrome, Jaundice, Obstructive

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
neostigmine methylsulfate，raceanisodamine hydrochloride
Sponsored by
Wanqing Gu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Inflammatory Response Syndrome focused on measuring Systemic Inflammatory Response Syndrome, Jaundice, Obstructive, anti-inflammatory

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHN Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

raceanisodamine & neostigmine

blank

Arm Description

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.

Patients do not receive special treatment after operation.

Outcomes

Primary Outcome Measures

C reactive protein
Indicator of the stress level.

Secondary Outcome Measures

Temperature
Indicator of systemic inflammatory response syndrome.
Heart rate
Indicator of systemic inflammatory response syndrome.
Respiratory
Indicator of systemic inflammatory response syndrome.
PaCO2
Indicator of systemic inflammatory response syndrome.
White blood cell count
Indicator of systemic inflammatory response syndrome.
Alanine aminotransferase（ALT)
Indicators of liver function.
Aspartate aminotransferase（AST）
Indicators of liver function.
Total bilirubin
Indicators of liver function.
Interleukin 1（IL-1）
Indicators of pro-inflammatory mediators
Interleukin 2（IL-2）
Pro-inflammatory mediators.
Interleukin 6（IL-6）
Pro-inflammatory mediators.
Interleukin 8（ IL-8）
Pro-inflammatory mediators
Tumor necrosis factor-α
Pro-inflammatory mediators.
Interleukin 10（ IL-10）
Anti-inflammatory mediators
Triiodothyronine(T3) & Thyroxin(T4) & Thyroid stimulating hormone(TSH)
Indicators of the stress level.

Full Information

First Posted
September 22, 2014
Last Updated
October 28, 2014
Sponsor
Wanqing Gu
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1. Study Identification

Unique Protocol Identification Number
NCT02279147
Brief Title
Cholinergic Anti-inflammatory Pathway in Prevention & Treatment of the SIRS in Patients With Jaundice After Operation.
Official Title
The Prevention and Treatment of SIRS in Patients With Cholestatic Jaundice After Operation.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wanqing Gu

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Inflammatory Response Syndrome, Jaundice, Obstructive
Keywords
Systemic Inflammatory Response Syndrome, Jaundice, Obstructive, anti-inflammatory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
raceanisodamine & neostigmine
Arm Type
Experimental
Arm Description
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.
Arm Title
blank
Arm Type
No Intervention
Arm Description
Patients do not receive special treatment after operation.
Intervention Type
Drug
Intervention Name(s)
neostigmine methylsulfate，raceanisodamine hydrochloride
Intervention Description
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.
Primary Outcome Measure Information:
Title
C reactive protein
Description
Indicator of the stress level.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Temperature
Description
Indicator of systemic inflammatory response syndrome.
Time Frame
One year
Title
Heart rate
Description
Indicator of systemic inflammatory response syndrome.
Time Frame
One year
Title
Respiratory
Description
Indicator of systemic inflammatory response syndrome.
Time Frame
One year
Title
PaCO2
Description
Indicator of systemic inflammatory response syndrome.
Time Frame
One year
Title
White blood cell count
Description
Indicator of systemic inflammatory response syndrome.
Time Frame
one year
Title
Alanine aminotransferase（ALT)
Description
Indicators of liver function.
Time Frame
One year
Title
Aspartate aminotransferase（AST）
Description
Indicators of liver function.
Time Frame
One year
Title
Total bilirubin
Description
Indicators of liver function.
Time Frame
One year
Title
Interleukin 1（IL-1）
Description
Indicators of pro-inflammatory mediators
Time Frame
One year
Title
Interleukin 2（IL-2）
Description
Pro-inflammatory mediators.
Time Frame
One year
Title
Interleukin 6（IL-6）
Description
Pro-inflammatory mediators.
Time Frame
One year
Title
Interleukin 8（ IL-8）
Description
Pro-inflammatory mediators
Time Frame
One year
Title
Tumor necrosis factor-α
Description
Pro-inflammatory mediators.
Time Frame
One year
Title
Interleukin 10（ IL-10）
Description
Anti-inflammatory mediators
Time Frame
One year
Title
Triiodothyronine(T3) & Thyroxin(T4) & Thyroid stimulating hormone(TSH)
Description
Indicators of the stress level.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wanqing GU, MD
Phone
+86-10-66938334
Email
13366779198@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yurong LIANG, MD
Phone
+86-10-66938334
Email
yurongliang@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GU wanqing
Organizational Affiliation
CHN Chinese PLA General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
CHN Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GU wanqing

12. IPD Sharing Statement

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

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