| CTRI Number |
CTRI/2026/01/100301 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
04/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The study is to determine how administration of methylene blue affect the dose of noradrenaline in a shock patient |
|
Scientific Title of Study
|
A randomized clinical study of the effects of early use of Methylene Blue on Noradrenaline dose in shock. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshita |
| Designation |
junior resident |
| Affiliation |
Subharti medical college |
| Address |
Department of Anaesthesiology and Critical Care, 2nd floor, Chhatrapati Shivaji Subharti Hospital ,Subharti University, NH58 Delhi-Hardiwar bypass road, Subhartipuram, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7838685670 |
| Fax |
|
| Email |
bhardwajakshita17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Salony Agarwal |
| Designation |
Professor |
| Affiliation |
Subharti medical college |
| Address |
Department of Anaesthesiology and Critical Care, 2nd floor, Chhatrapati Shivaji Subharti Hospital ,Subharti University, NH58 Delhi-Hardiwar bypass road, Subhartipuram, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7838685670 |
| Fax |
|
| Email |
bhardwajakshita17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akshita |
| Designation |
junior resident |
| Affiliation |
Subharti medical college |
| Address |
Department of Anaesthesiology and Critical Care, 2nd floor, Chhatrapati Shivaji Subharti Hospital ,Subharti University, NH58 Delhi-Hardiwar bypass road, Subhartipuram, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7838685670 |
| Fax |
|
| Email |
bhardwajakshita17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chhatrapati Shivaji ,Subharti University, NH58 Delhi-Hardiwar bypass road, Subhartipuram, Meerut |
|
|
Primary Sponsor
|
| Name |
Subharti Medical College |
| Address |
Department of Anaesthesiology and Critical Care, 2nd floor, Chhatrapati Shivaji ,Subharti University, NH58 Delhi-Hardiwar bypass road, Subhartipuram, Meerut |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akshita |
Chhatrapati Shivaji Subharti Hospital |
Department of Anaesthesiology and Critical Care, 2nd floor, Subharti University, NH58 Delhi-Hardiwar bypass road, Subhartipuram, Meerut
Meerut
UTTAR PRADESH |
7838685670
bhardwajakshita17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UNIVERSITY ETHICS COMMITTEE (MEDICAL) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I999||Unspecified disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Methylene blue and Vasopressin |
Intravenous Vasopressin 0.04 units/min
Intravenous Methylene Blue 1 mg/kg bolus over 30 minutes, then by a 0.5 mg/kg infusion over 24 hours
|
| Comparator Agent |
Vasopressin and Normal Saline |
Intravenous vasopressin infusion of 0.04 units/min and infusion saline for 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient admitted in ICU with shock and requires noradrenaline to maintain a mean arterial pressure (MAP) of greater than or equal to 65 mm Hg after appropriate fluid resuscitation. |
|
| ExclusionCriteria |
| Details |
relatives/patient refused to provide consent
With unstable coronary artery syndrome, stroke
chronic renal failure requiring dialysis,
malignancy or irreversible illness with a high mortality risk,
acute mesenteric ischemia,
pregnancy
known hypersensitivity to norepinephrine or Methylene Blue or Vasopressin
Glucose-6-phosphate dehydrogenase (G6PD) deficiency
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CHANGE IN NORAD DOSE AFTER STARTING VASOPRESSIN AND METHYLENE BLUE |
0 hours, 6 hours, 12 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in Lactate Levels,
Urine Output
Sequential organ failure assessment (SOFA) score.
CRP levels
|
0hr 6hr 12hr 24hr |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS STUDY IS A RANDOMIZED CLINICAL STUDY OF THE EFFECTS OF EARLY USE OF METHYLENE BLUE ON NORADRENALINE DOSE IN SHOCK WHERE THERE WILL BE A COMPARISON BETWEEN TWO GROUPS WHERE ONE WILL RECEIVE ONLY VASO AND ANOTHER VASO+ METHYLENE BLUE AFTER A CERTAIN DOSE OF NORAD. |