A Phase 1 interventional study of Saline and Methylene Blue in Jaundice, sponsored by Jiaolin Ning,MD. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-10-01.
Sponsored by Jiaolin Ning,MD · Phase 1, Interventional, and Treatment
Among 10 studies in Jaundice with a site in China — 2 open to participants now, 2 under way, none of them phase 3. Jaundice · China.
Among the 10 studies in Jaundice with a site in China, this one is the only one that started in 2019, is the only one in phase 1, and was the 7th registered.
84 studies on the registry are indexed under Jaundice; 13 are open to participants now.
This study's planned enrollment of 64 is below the median of 79 across 47 interventional studies indexed under Jaundice.
Browse Jaundice studies →2 of the 10 studies in Jaundice with a site in China are open now, in 1 country. Each count lists the studies.
Of the 11 Jaundice studies recruiting now, 3 (27%) set no upper age limit and 7 (64%) stop at 75 or younger; 6 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 1 started in 2019.
Median enrollment 67 across the 4 interventional studies, 235 across the 6 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
None of the 10 has an industry lead sponsor. The 9 most frequent:
This is the only study on the registry with Jiaolin Ning,MD as lead sponsor.
Jiaolin Ning,MD has 1 study filed under Jaundice — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Jaundice with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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)
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.
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.
Exclusion Criteria:
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.
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.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Drug: Methylene Blue
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).
Drug: Saline
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
Also known as: Placebo group
Patients in the methylene blue group were given methylene blue before anesthesia and continued intraoperative pumping
Also known as: Methylene blue group
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
Time frame: 3 days
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2019 (actual). Primary completion is estimated for Jan 2021, 21 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methylene Blue