Pre-treatment With Methylene Blue Prevent Peri-operative... | NCT03406676

Studies
Pre-treatment With Methylene Blue Prevent Peri-operative Reduced Systemic Vascular Resistance

NCT03406676

Sponsor

Southwest Hospital, China

Status

Unknown status

Last Update Posted

Jan 23, 2018Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Obstructive Jaundice

Interventions

Methylene Blue

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

Oct 30, 2018Estimated

Completion Date

Oct 30, 2018Estimated

First Submitted Date

Jan 4, 2018

First Submission Date that Met QC Criteria

Jan 15, 2018

First Posted Date

Jan 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2018

Last Update Posted Date

Jan 23, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shuguo Zheng, MD, Professor of Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China, Southwest Hospital, ChinaPrincipal Investigator

Lead Sponsor

Southwest Hospital, ChinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To explore the effects of pre-treatment with methylene blue on reduced perioperative vascular resistance in patients with obstructive jaundice.

Detailed Description

Hemodynamic characteristics of patients with obstructive jaundice are high cardiac output, low peripheral vascular resistance. The molecular basis for this feature is the increased production of NO. Methylene blue can increase peripheral resistance, the mechanism is: methylene blue is an oxidoreductase inhibitor, can inhibit the increased production of NO in the vascular endothelium, thereby increasing peripheral vascular resistance.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Methylene blue	Experimental	2mg / Kg of methylene blue in volume of 50ml is administrated I.V before anesthesia induction.	Drug: Methylene Blue
saline	No Intervention	50ml of saline is administrated I.V before anesthesia induction.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methylene Blue	Drug	2mg / Kg of methylene blue in volume of 50ml is administrated I.V before anesthesia induction.	Methylene blue

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peripheral vascular resistance	the dose of vasoconstrictors used to Maintain Peripheral vascular resistance in the normal range (800 ~ 1200dyns / cm5)	through operation completion, an average of 6 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged between 18-60 years;
American Society of Anesthesiologists（ASA） grade I~III;
TBIL>ULN and TBA>ULN; The patients with obstructive jaundice.

Exclusion Criteria:

Organs dysfunction(heart,lungs and etc);
Mental disorders;
in other clinical trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ning Jiaolin, Doctor	Contact	0086-15808014085		Njiaolin1976@126.com

Overall Officials

Name	Affiliation	Role
Zheng ShuGuo	MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southwest Hospital	Recruiting	Chongqing	Chongqing Municipality	400038	China

Condition Browse Module

MeSH Terms

ID	Term
D041781	Jaundice, Obstructive

Ancestor Terms

ID	Term
D007565	Jaundice
D006932	Hyperbilirubinemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008751	Methylene Blue

Ancestor Terms

ID	Term
D010640	Phenothiazines
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006575	Heterocyclic Compounds, 3-Ring

Browse Leaves

Not provided

Browse Branches

Not provided