Obstructive JaundiceNCT03406676
Pre-treatment With Methylene Blue Prevent Peri-operative Reduced Systemic Vascular Resistance
A study testing Methylene Blue in people with Obstructive Jaundice, run by Southwest Hospital, China at 2 sites in China.
Trial summary
To explore the effects of pre-treatment with methylene blue on reduced perioperative vascular resistance in patients with obstructive jaundice. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Jaundice
- What is being tested?
- Methylene Blue
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2017to 30 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18-60 years;
- American Society of Anesthesiologists（ASA） grade I~III;
- TBIL>ULN and TBA>ULN; The patients with obstructive jaundice.
Who cannot join
- Organs dysfunction(heart,lungs and etc);
- Mental disorders;
- in other clinical trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Ning Jiaolin, 0086-15808014085, Njiaolin1976@126.com
- Recruiting
Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Ning Jiaolin, Doctor, 0086-15808014085, Njiaolin1976@126.com
About this study
Official title: The Preventive Effects of Pre-treatment With Methylene Blue for Vascular Paralysis of the Patients With Obstructive Jaundice During Operation
To explore the effects of pre-treatment with methylene blue on reduced perioperative vascular resistance in patients with obstructive jaundice.
Read the 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.
- Conditions
- Obstructive Jaundice
- Being tested
- Methylene Blue
- Keywords
- Methylene blue; Peripheral vascular resistance
- Medical subject headings
- Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene BlueDrug
Also called Methylene blue injection
2mg / Kg of methylene blue in volume of 50ml is administrated I.V before anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| Methylene blue | Experimental | 2mg / Kg of methylene blue in volume of 50ml is administrated I.V before anesthesia induction. Receives: Drug: Methylene Blue |
| saline | No intervention | 50ml of saline is administrated I.V before anesthesia induction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral vascular resistance
the dose of vasoconstrictors used to Maintain Peripheral vascular resistance in the normal range (800 ~ 1200dyns / cm5)
Measured: through operation completion, an average of 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Aug 2017
- Primary completion30 Oct 2018 (estimated)
- Study completion30 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive JaundiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuguo Zheng, MD, Southwest Hospital, China
- Investigators
- Zheng ShuGuo, Principal investigator, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406676
- Sponsor's protocol ID
- MZK002
- Status last verified
- Jan 2018
- First submitted
- 4 Jan 2018
- Last updated
- 23 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Preventive Effects of Pre-treatment With Methylene Blue for Vascular Paralysis of the Patients With Obstructive Jaundice During Operation
- ClinicalTrials.gov ID
- NCT03406676
- Acronym / sponsor ID
- MZK002
- Conditions
- Obstructive Jaundice
- Keywords
- Methylene blue; Peripheral vascular resistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Oct 2018 (estimated)
- Study completion
- 30 Oct 2018 (estimated)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylene blue | Experimental | Drug: Methylene Blue2mg / Kg of methylene blue in volume of 50ml is administrated I.V before anesthesia induction. |
| saline | No intervention | –50ml of saline is administrated I.V before anesthesia induction. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18-60 years;
- American Society of Anesthesiologists（ASA） grade I~III;
- TBIL>ULN and TBA>ULN; The patients with obstructive jaundice.
Key exclusion criteria (3 listed)
- Organs dysfunction(heart,lungs and etc);
- Mental disorders;
- in other clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylene BlueAlso: Methylene blue injection2mg / Kg of methylene blue in volume of 50ml is administrated I.V before anesthesia induction. | Drug | Methylene blue |
Primary outcome
Peripheral vascular resistance
Time frame: through operation completion, an average of 6 hours
the dose of vasoconstrictors used to Maintain Peripheral vascular resistance in the normal range (800 ~ 1200dyns / cm5)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zheng ShuGuo principal investigator
MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylene Blue in people with Obstructive Jaundice, run by Southwest Hospital, China at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ning Jiaolin, Doctor (0086-15808014085, Njiaolin1976@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral vascular resistance (time frame: through operation completion, an average of 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.