JaundicePhase 1NCT04109859

Effect of Methylene Blue on Perioperative Organ Function in Patients With Obstructive Jaundice

A Phase 1 study testing Saline and Methylene Blue in people with Jaundice, run by Jiaolin Ning,MD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

Increased production of vasodilating substances such as NO plays an important role in the development of vasoplegic syndrome caused by obstructive jaundice.Methylene blue plays a role in raising blood pressure by inhibiting the vasodilator Nitric Oxide (NO) Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Jaundice
What is being tested?: Saline and Methylene Blue
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 1 siteChina
Study dates: 1 Apr 2019to 21 Jan 2021
Phase: Phase 1
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

Age: 18~70 years old;
ASA grade I~III;
Ability to comply with research protocols;
Patients with obstructive jaundice: patients with total bilirubin greater than 50umol/L;
Voluntarily participate in the study and sign the informed consent form. -

Who cannot join

ASA IV~V grade;
women during lactation and pregnancy;
Patients with severe heart disease or lung disease before surgery;
Participating in other trials in the last 2 months;
Those whose mental state cannot cooperate, who suffer from mental illness, have no self-control, and cannot express clearly;
Those who refuse to sign the informed consent form. -

Trial locations and contacts

1 site in 1 country.

China1 site

department of anesthesia, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China
Chongqing, Chongqing Municipality, 400038

Other trials in China

About this study

Read the detailed description

The level of circulating hydrogen sulfide (H2S) in patients with obstructive jaundice is significantly increased. As a direct opener of KATP channels in vivo, H2S also has diastolic peripheral vasculature . H2S participates in the occurrence of vasoplegic syndrome in patients with obstructive jaundice by interacting with NO. However, it is unclear whether methylene blue can relieve vasoplegic syndrome in patients with obstructive jaundice by inhibiting the vasodilating effect of substances such as H2S and NO.

Therefore, this clinical study intends to include patients with obstructive jaundice, using randomized, controlled, prospective study to explore the effect of methylene blue on the occurrence of vasoplegic syndrome, organ function and prognosis in patients with obstructive jaundice.

Conditions: Jaundice
Being tested: Saline, Methylene Blue
Medical subject headings: Jaundice

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SalineDrug
Also called Placebo group
When using saline, if found mean arterial pressure <65mmHg, Cardic Output>4L/min, Sequential Vascular Response<800 (dyne×sec)/cm, starting dose of norepinephrine 0.04ug/min/kg
Methylene BlueDrug
Also called Methylene blue group
Patients in the methylene blue group were given methylene blue before anesthesia and continued intraoperative pumping

Study groups in NCT04109859
Study group	Role	What they receive
Methylene blue group	Experimental	Before the anesthesia was intubated, the patients in the methylene blue group were given a 2 mg/Kg methylene blue 50 ml intravenously for 10 min; continuous constant speed pumping methylene blue(0.5mg/Kg/h). Receives: Drug: Methylene Blue
Placebo group	Placebo comparator	Before the anesthesia was intubated, the placebo group was given 50 ml of normal saline for 10 min.continuous constant speed pumpingnormal saline (10ml/h). Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Acute physiology and chronic health evaluation IIScore sheet
use this Score sheet to evaluation of postoperative organ function in patients.The total score is 0 to 71
Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201921 Jan 2021

First posted30 Sep 2019
Study start1 Apr 2019
Primary completion21 Jan 2021 (estimated)
Study completion21 Jan 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 64 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04109859
Sponsor's protocol ID: KY201999
Status last verified: Sep 2019
First submitted: 25 Sep 2019
Last updated: 1 Oct 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1/2
RTX001 Autologous Engineered Macrophages for Liver Cirrhosis
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Abdominal Massage for Newborn Jaundice
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Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation
Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice
Active, not recruiting
Newborn Abdominal Massage to Prevent Hyperbilirubinemia
Newborn Jaundice
Not yet recruiting
Suprapapillary Versus Transpapillary Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction
Biliary Tract Neoplasms, Biliary Drainage

All Jaundice trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Methylene Blue on Perioperative Organ Function in Patients With Obstructive Jaundice
ClinicalTrials.gov ID: NCT04109859
Acronym / sponsor ID: KY201999
Conditions: Jaundice
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 64 participants (estimated)
Lead sponsor: Jiaolin Ning,MDUniversity, hospital or other
Study start: 1 Apr 2019 (actual)
Primary completion: 21 Jan 2021 (estimated)
Study completion: 21 Jan 2021 (estimated)
First posted: 30 Sep 2019 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Methylene blue group	Experimental	Drug: Methylene BlueBefore the anesthesia was intubated, the patients in the methylene blue group were given a 2 mg/Kg methylene blue 50 ml intravenously for 10 min; continuous constant speed pumping methylene blue(0.5mg/Kg/h).
Placebo group	Placebo comparator	Drug: SalineBefore the anesthesia was intubated, the placebo group was given 50 ml of normal saline for 10 min.continuous constant speed pumpingnormal saline (10ml/h).

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age: 18~70 years old;
ASA grade I~III;
Ability to comply with research protocols;
Patients with obstructive jaundice: patients with total bilirubin greater than 50umol/L;
Voluntarily participate in the study and sign the informed consent form. -

Key exclusion criteria (6 listed)

ASA IV~V grade;
women during lactation and pregnancy;
Patients with severe heart disease or lung disease before surgery;
Participating in other trials in the last 2 months;
Those whose mental state cannot cooperate, who suffer from mental illness, have no self-control, and cannot express clearly;

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
SalineAlso: Placebo groupWhen using saline, if found mean arterial pressure <65mmHg, Cardic Output>4L/min, Sequential Vascular Response<800 (dyne×sec)/cm, starting dose of norepinephrine 0.04ug/min/kg	Drug	Placebo group
Methylene BlueAlso: Methylene blue groupPatients in the methylene blue group were given methylene blue before anesthesia and continued intraoperative pumping	Drug	Methylene blue group

Primary outcome

Acute physiology and chronic health evaluation IIScore sheet
Time frame: 3 days
use this Score sheet to evaluation of postoperative organ function in patients.The total score is 0 to 71

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
Individual participant dataSharing planned: No

Related trials for Jaundice

Active, not recruitingPhase 1/2
RTX001 Autologous Engineered Macrophages for Liver Cirrhosis
End-stage Liver Disease (ESLD), Cirrhosis, Liver
Recruiting
Abdominal Massage for Newborn Jaundice
Neonatal Jaundice
Not yet recruiting
Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation
Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice
Active, not recruiting
Newborn Abdominal Massage to Prevent Hyperbilirubinemia
Newborn Jaundice
Not yet recruiting
Suprapapillary Versus Transpapillary Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction
Biliary Tract Neoplasms, Biliary Drainage

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.

Jiaolin Ning, MD principal investigator

Professor of department of anesthesia, Southwest Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Saline and Methylene Blue in people with Jaundice, run by Jiaolin Ning,MD at 1 site 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 5 inclusion and 6 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 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute physiology and chronic health evaluation IIScore sheet (time frame: 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04109859.

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 1 Oct 2019; AzTrials last refreshed its copy on 7 Nov 2026.