| CTRI Number |
CTRI/2025/08/093217 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study in patients with septic shock to compare the effect of two different doses of methylene blue on reducing the need of blood pressure increasing medicine (vasopressors) |
|
Scientific Title of Study
|
Comparison of two different doses of methylene blue as an adjunctive in patients with septic shock: A randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nitin Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Trauma and Emergency (Anaesthesiology)
IGIMS Campus
Sheikhpura
Patna
BIHAR
800014
India |
| Phone |
08076070302 |
| Fax |
|
| Email |
kumarnitin516@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitin Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Trauma and Emergency (Anaesthesiology)
IGIMS Campus
Sheikhpura
Patna
BIHAR
800014
India |
| Phone |
08076070302 |
| Fax |
|
| Email |
kumarnitin516@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitin Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Trauma and Emergency (Anesthesiology)
IGIMS Campus
Sheikhpura
Patna
BIHAR
800014
India |
| Phone |
08076070302 |
| Fax |
|
| Email |
kumarnitin516@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Institute of Medical Sciences |
| Address |
IGIMS Campus
Sheikhpura
Patna 800014 |
| Type of Sponsor |
Government 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 |
| Nitin Kumar |
IGIMS |
Department of Trauma & Emergency IGIMS Campus Sheikhpura
Patna
BIHAR |
08076070302
kumarnitin516@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IGIMS, PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B95-B97||Bacterial and viral infectious agents, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
In group A,Injection Methylene Blue in dose of 2mg/kg IV will be used. |
In this group, all the patients with septic shock on norepinephrine will receive Injection Methylene Blue in dose of 2mg/kg as IV infusion over 6 hrs for 3 consecutive days. |
| Comparator Agent |
In group B, Injection Methylene Blue in dose of 1mg/kg IV will be used. |
In this group, all the patients with septic shock on norepinephrine will receive Injection Methylene Blue in dose of 1mg/kg as IV infusion over 6hrs for 3 consecutive days. |
| Intervention |
Methylene Blue as an adjuvant to vasopressors in patient with septic shock |
All the patients admitted in ICU with a diagnosis of septic shock and on vasopressors will receive intravenous infusion of Methylene Blue as adjuvant over 6 hrs for 3 consecutive days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient having body weight 50 - 70 kg with septic shock as defined by sepsis 3 criteria - highly suspected or confirmed infection, requiring norepinephrine to maintain a mean arterial pressure more than or equal to 65 mmHg and serum lactate more than 2 mmol/L after adequate fluid resuscitation. |
|
| ExclusionCriteria |
| Details |
More than 24 hours since initiation of norepinephrine
Pregnancy
High probability of death within 48 hours
Concurrent hemorrhagic, obstructive or hypovolemic shock
Refusal of the patient or decision maker to participate
Pending damage control surgery
Major burn surgery
History of glucose 6 phosphate dehydrogenase deficiency
Allergy to methylene blue, phenothiazines or food dyes
Recent intake (less than 4 weeks) of selective serotonin re-uptake inhibitors
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the time taken to vasopressor discontinuation after starting of methylene blue |
From start of methylene blue infusion till day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total duration of vasopressor support |
From start of vasopressor administration until cessation |
| Serum lactate clearance |
at 24 hour, 48 hour and 72 hour after starting of vasopressors |
| Incidence of vasopressin requirement |
At 24hr, 48hr & 72hr after starting the methylene blue till day 7 |
| Adverse event such as Hemolysis, Serotonin Syndrome, Cyanosis, Nausea, Vomiting, Arrhythmias |
At 24hr, 48hr & 72hr after starting the methylene blue till the day 7 |
| ICU length of stay |
Time duration for which patients remain in ICU |
| 28 days all cause mortality |
Mortality till 28 days after starting of vasopressors |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="0"
Months="6"
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 prospective, randomized, double-blind, two-arm controlled trial will evaluate the catecholamine-sparing effect of methylene blue (MB) when used as an adjunct to standard vasopressor therapy in adult patients with septic shock. One hundred ICU patients (18-70 years) meeting Sepsis-3 criteria and requiring norepinephrine after adequate resuscitation will be allocated 1:1 to receive either 2 mg/kg IV methylene blue (Group A) or 1 mg/kg IV methylene blue (Group B), each infused over six hours once daily for three consecutive days. All other sepsis management, including vasopressin rescue (initiated if norepinephrine is more than 0.25 µg/kg/min), will follow Surviving Sepsis Campaign guidelines.
The primary outcome is time (hours) to successful discontinuation of norepinephrine, defined as maintenance of mean arterial pressure is more than 65 mmHg for 24 h without vasopressors. Secondary outcomes include total vasopressor duration, MAP and lactate trends over 72 h, vasopressin requirement, adverse events (e.g., hemolysis, serotonin syndrome), ICU length of stay, and 28-day all-cause mortality. Data will be analysed with SPSS v23; p < 0.05 will be considered significant. The study is approved by the IGIMS Institutional Ethics Committee, and written informed consent will be obtained from all participants. |