Clinical trial NCT02279147: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Systemic Inflammatory Response Syndrome
Jaundice, Obstructive
Keywords: Systemic Inflammatory Response Syndrome
Jaundice, Obstructive
anti-inflammatory
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2014-10-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: C reactive protein
timeFrame: One year
Secondary outcomes:
measure: Temperature
timeFrame: One year
measure: Heart rate
timeFrame: One year
measure: Respiratory
timeFrame: One year
measure: PaCO2
timeFrame: One year
measure: White blood cell count
timeFrame: one year
measure: Alanine aminotransferase（ALT)
timeFrame: One year
measure: Aspartate aminotransferase（AST）
timeFrame: One year
measure: Total bilirubin
timeFrame: One year
measure: Interleukin 1（IL-1）
timeFrame: One year
measure: Interleukin 2（IL-2）
timeFrame: One year
measure: Interleukin 6（IL-6）
timeFrame: One year
measure: Interleukin 8（ IL-8）
timeFrame: One year
measure: Tumor necrosis factor-α
timeFrame: One year
measure: Interleukin 10（ IL-10）
timeFrame: One year
measure: Triiodothyronine(T3) & Thyroxin(T4) & Thyroid stimulating hormone(TSH)
timeFrame: One year
Other outcomes:
Locations:
city: Beijing
country: China
facility: CHN Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: CHN Chinese PLA General Hospital
name: GU wanqing
role: STUDY_CHAIR
References: