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Trial registered on ANZCTR


Registration number
ACTRN12611000980932
Ethics application status
Not yet submitted
Date submitted
10/09/2011
Date registered
14/09/2011
Date last updated
14/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Whether the antioxidants can prevent patients with obstructive jaundice from the hypotension in operation.
Scientific title
Compared with controls ,whether the treatment of antioxidants can alleviate vascular hyporesponsiveness in patients with obstructive jaundice
Secondary ID [1] 263018 0
Nil
Universal Trial Number (UTN)
U1111-1124-2612
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obstructive jaundice 270742 0
vascular hyporesponsiveness 270743 0
Condition category
Condition code
Cardiovascular 270920 270920 0 0
Diseases of the vasculature and circulation including the lymphatic system
Anaesthesiology 270921 270921 0 0
Other anaesthesiology
Oral and Gastrointestinal 270946 270946 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Glutathione reduced by Intravenous injection,240mg,every day,7 days before abdominal operation
Intervention code [1] 269361 0
Treatment: Drugs
Comparator / control treatment
intravenous saline injection
Control group
Placebo

Outcomes
Primary outcome [1] 279589 0
blood pressure from radial artery cannula
Timepoint [1] 279589 0
every 5 minutes for the duration of the operation
Primary outcome [2] 279618 0
pulmonary arterial wedge pressure from pulmonary artery balloon flow catheter(Swan-ganz catheter)
Timepoint [2] 279618 0
every 5 minutes for the duration of the operation
Primary outcome [3] 279619 0
heart rate from monitor
Timepoint [3] 279619 0
every 5 minutes for the duration of the operation
Secondary outcome [1] 287978 0
the expression of alpha-advenergic receptors protein on mesenteric artery by Westen blot
Timepoint [1] 287978 0
immediately after operation
Secondary outcome [2] 294045 0
mRNA expressing alpha-advenergic receptors on mesenteric artery by Real time PCR(Polymerase chain reaction)
Timepoint [2] 294045 0
immediately after operation

Eligibility
Key inclusion criteria
participants with obstructive jaundice(serum total bilirubin>100umol/L)caused by neoplasm of the bile duct or the head of the pancreas who will undergo abdominal operation
Minimum age
50 Years
Maximum age
70 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
females,<50 years >70 years,BMI>30kg/m2 <18kg/m2,diabetes,cardiovascular diseases

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using a randomisation table created by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3822 0
China
State/province [1] 3822 0
Shanghai

Funding & Sponsors
Funding source category [1] 269820 0
Government body
Name [1] 269820 0
National Natural Science Foundaton of China
Address [1] 269820 0
83 Shuangqing Road
Haidian District
Beijing China
100085
Country [1] 269820 0
China
Primary sponsor type
Hospital
Name
Department of Anesthesiology,Easten Hepatobiliary Hospital
Address
225 Changhai Road
Yangpu District
Shanghai China
200438
Country
China
Secondary sponsor category [1] 268853 0
Individual
Name [1] 268853 0
Weifeng Yu PhD.MD.
Address [1] 268853 0
Department of Anesthesiology,Easten Hepatobiliary Surgery Hospital
225 Changhai Road
Yangpu District
Shanghai China
200438
Country [1] 268853 0
China

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 271787 0
The Ethics Committee of The Second Military Medical University
Ethics committee address [1] 271787 0
800 Xiangyin Road
Yangpu District
Shanghai China
200433
Ethics committee country [1] 271787 0
China
Date submitted for ethics approval [1] 271787 0
01/09/2011
Approval date [1] 271787 0
Ethics approval number [1] 271787 0

Summary
Brief summary
1.Vascular hyporesponsiveness in patients with obstructive jaundice is a common problem during operation. It causes high complication and high mortality during preoperative period. But the mechanism is still unknown. There is still no effective method to prevent and treat vascular hyporesponsiveness.
2.Patients with obstructive jaundice produce great amount of Recative Oxygen Species(ROS). The excessive ROS seem to have two effects on blood vessel by the a-advenergic receptors(a-AR). The acute and short-term effect changes the expression, affinity, phosphorylation level of a-AR and cause the decreased contractility of blood vessel. The chronic and long-term effect causes the remodeling of blood vessel by a-AR signal pathway through cell hypertrophy, hyperplasia and apoptosis. These two effects may result in vascular hyporesponsiveness.
3.Therefore, the present research focuses on the vascular hyporesponsiveness in patients with obstructive jaundice caused by ROS through a-AR. The research may put forward feasible explanations of unstable haemodynamics in obstructive jaundice patients. It may also offer a new target to prevent and treat the unstable haemodynamics to increase the preoperative safety in obstructive jaundice patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33110 0
Address 33110 0
Country 33110 0
Phone 33110 0
Fax 33110 0
Email 33110 0
Contact person for public queries
Name 16357 0
Jiaying Chen .MD.
Address 16357 0
Department of Anesthesiology,Easten Hepatobiliary Surgery Hospital
225 Changhai Road
Yangpu District
Shanghai China
200438
Country 16357 0
China
Phone 16357 0
+86 015850557096
Fax 16357 0
+86 021 65564166
Email 16357 0
willde.pchome@yahoo.com.cn
Contact person for scientific queries
Name 7285 0
Weifeng Yu.PhD.MD.
Address 7285 0
Department of Anesthesiology,Easten Hepatobiliary Surgery Hospital
225 Changhai Road
Yangpu District
Shanghai China
200438
Country 7285 0
China
Phone 7285 0
86 013901961704
Fax 7285 0
+86 021 65564166
Email 7285 0
ywf808@sohu.com

No information has been provided regarding IPD availability
Summary results
No Results