ClinicalTrials.gg
Status unknownNCT03406676Updated Jan 23, 2018

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

An interventional study of Methylene Blue in Obstructive Jaundice, sponsored by Southwest Hospital, China. Status unknown at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Southwest Hospital, China · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Aug 2017, registered Jan 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Obstructive Jaundice

Browse trials for

Keywords

  • Methylene blue; Peripheral vascular resistance
03

In context

Jaundice, Obstructive

62 studies on the registry are indexed under Jaundice, Obstructive; 15 are open to participants now.

This study's planned enrollment of 70 is close to the median of 75 across 40 interventional studies indexed under Jaundice, Obstructive.

Browse Jaundice, Obstructive studies →

Lead sponsor

Southwest Hospital, China is the lead sponsor of 87 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Aged between 18-60 years;
  2. (ASA) grade I\~III;
  3. > and TBA>ULN; The patients with obstructive jaundice.

Exclusion criteria

Exclusion Criteria:

  1. Organs dysfunction(heart,lungs and etc);
  2. Mental disorders;
  3. in other clinical trial.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Methylene blue

    2mg / Kg of methylene blue in volume of 50ml is administrated I.V before anesthesia induction.

    Drug: Methylene Blue

  • No intervention
    saline

    50ml of saline is administrated I.V before anesthesia induction.

Interventions

  • 2mg / Kg of methylene blue in volume of 50ml is administrated I.V before anesthesia induction.

    Also known as: Methylene blue injection

06

What researchers measure

Primary outcomes

  1. Peripheral vascular resistance

    the dose of vasoconstrictors used to Maintain Peripheral vascular resistance in the normal range (800 \~ 1200dyns / cm5)

    Time frame: through operation completion, an average of 6 hours

07

Study locations

2 of 2 sites recruiting
  • Southwest Hospital
    Chongqing, Chongqing 400038, China
    Recruiting
  • Southwest Hospital
    Chongqing, Chongqing 400038, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2017 (actual). Primary completion is estimated for Oct 2018, 14 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 4, 2018
First posted
Jan 23, 2018
StartActual
Aug 1, 2017
Primary completionEst.
Oct 30, 2018
CompletionEst.
Oct 30, 2018
Last update
Jan 23, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03406676
Lead sponsor
Southwest Hospital, China
Responsible party
Shuguo Zheng, MD (Professor of Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China, Southwest Hospital, China) — Principal investigator
First posted
Jan 23, 2018
Start date
Aug 1, 2017
Primary completion
Oct 30, 2018 (estimated)
Completion
Oct 30, 2018 (estimated)
Last update
Jan 23, 2018

Study contacts

Ning Jiaolin, Doctor
Contact
Njiaolin1976@126.com
0086-15808014085
Zheng ShuGuo
principal investigator · MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Methylene Blue

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