Neonatal SepsisPhase 2/3NCT06306001
Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock
A Phase 2/3 study testing Methylene Blue in people with Neonatal Sepsis and Shock, Septic, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Preterm infants (born at less than 37 weeks of pregnancy) sometimes develop a serious blood infection leading to low blood pressure, which does not respond to saline or to the standard medicines for increasing blood pressure, such as dopamine and epinephrine. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Neonatal Sepsis, Shock, Septic
- What is being tested?
- Methylene Blue
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteIndia
- Study dates
- 15 Mar 2024to Feb 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- excluded if ≥1 criterion positive:
- G6PD deficient or family history of G6PD deficiency
- Potentially lethal malformation
- Congenital heart disease
- Severe acute kidney injury
- Family history of allergy to methylene blue or food dyes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Post Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh, 160012
About this study
Official title: Intravenous Methylene Blue for Treating Fluid-refractory, Catecholamine-resistant, Neonatal Septic Shock: a Randomized, Placebo-controlled, Superiority Trial
Preterm infants (born at less than 37 weeks of pregnancy) sometimes develop a serious blood infection leading to low blood pressure, which does not respond to saline or to the standard medicines for increasing blood pressure, such as dopamine and epinephrine. The goal of this research study is to compare the effect of giving an injectable medicine called Methylene blue (MB) versus not giving MB to such preterm infants who are unresponsive to standard treatment. The main questions that this study aims to answer is:
- Whether MB treatment reduces death to any cause as compared to no MB treatment.
- Whether treatment with MB reduces the time to achieve normal blood pressure
- Whether treatment with MB reduces the time to stoppage of all blood pressure medications, steroids and normal saline.
- Whether treatment with MB improves heart function as measured by echocardiography at 24 and 48 hours.
Read the detailed description
Preterm infants with definite or probable sepsis and fluid-refractory, catecholamine-resistant septic shock will be eligible for enrolment if they have no contraindication to receive MB. After obtaining parental consent, they will be stratified as per the first-line catecholamine used and randomly allocated to receive MB (bolus followed by infusion) or no MB for 24 hours. They will be observed for all-cause mortality (primary outcome), cause-specific mortality, time to achieve hemodynamic stability and adverse effects (secondary outcomes) over a 7-day period, all-cause mortality and cause-specific mortality hospital stay and duration of hospital stay.
The main questions it aims to answer are
- To determine whether treatment with intravenous MB therapy reduces all-cause mortality when compared to no MB treatment, among preterm neonates with catecholamine-resistant septic shock
- To compare the time to achieve therapeutic endpoints among preterm neonates with catecholamine-resistant septic shock treated with intravenous MB versus no MB
- To compare time to stoppage of all inotrope/vasopressor treatment among preterm neonates with catecholamine-resistant septic shock treated with intravenous MB versus no MB
- To compare echocardiographic parameters (at 24 hours after randomization) among preterm neonates with catecholamine-resistant septic shock treated with intravenous MB versus no MB
- Conditions
- Neonatal Sepsis, Shock, Septic
- Being tested
- Methylene Blue, Placebo
- Keywords
- Methylene blue, Neonate, Septic shock, Clinical trial
- Medical subject headings
- Neonatal Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene BlueDrug
Also called MB
Subjects in the intervention arm will receive a 1 mg/kg bolus of methylene blue over 30 minutes, followed by an infusion of 0.15 mg/kg/h. The infusion rate may be increased in steps of 0.15 mg/kg/h every 30 minutes until a maximum of 0.5 mg/kg/h.
PlaceboOther
Also called Normal saline
Subjects in the placebo arm will receive normal saline in the same volumetric dose as methylene blue in the intervention arm
| Study group | Role | What they receive |
|---|---|---|
| Methylene blue | Experimental | Subjects in the intervention arm will receive a 1 mg/kg bolus of methylene blue over 30 minutes, followed by an infusion of 0.15 mg/kg/h. The infusion rate may be increased in steps of 0.15 mg/kg/h every 30 minutes until a maximum of 0.5 mg/kg/h. Receives: Drug: Methylene Blue |
| Placebo infusion | Placebo comparator | Subjects in the control arm will receive a placebo infusion (normal saline) at the same volumetric rate. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality within 7 days after randomization
Mortality due to any cause over 7 days after randomization
Measured: 7 days
Secondary outcomes (16)
Time taken to achieve therapeutic end-points within 7 days after randomization
Time taken to achieve therapeutic end points of shock (which include capillary refill time less than 3 seconds, normal volume pulses, warm extremities, urine output greater than 1 ml/kg/h, normal sensorium, normal mean blood pressure, normal systolic blood pressure and normal diastolic blood pressure) up to 7 days after randomization.
Measured: 7 days
Time taken to stop all inotrope/vasopressor treatment within 7 days after randomisation
Time taken for all inotrope and vasopressor therapy to finally stop up to a maximum of 7 days after randomisation
Measured: 7 days
Echocardiographic fractional shortening at 24 hour after randomization
Fractional shortening will be calculated on echocardiography by measuring the percentage change in the left ventricular diameter during systole at 24 hours after randomization.
Measured: 24 hour
Left ventricular end-diastolic diameter (LVEDD) by echocardiography at 24 hour after randomization
Left ventricular end-diastolic diameter (LVEDD) will be measured in millimetres by echocardiography at 24 hour after randomization
Measured: 24 hour
Left ventricular end-systolic diameter (LVESD) by echocardiography at 24 hour after randomization
Left ventricular end-systolic diameter (LVESD) will be measured in millimeters by echocardiography at 24 hour after randomization
Measured: 24 hour
Aortic diameter by echocardiography at 24 hour after randomization
Aortic diameter will be measured in millimeters by echocardiography at 24 hour after randomization
Measured: 24 hour
Velocity time integral (LVI) by echocardiography at 24 hours after randomization
Velocity time integral (LVI) will be measured in centimeters by echocardiography at 24 hours after randomization to calculate the cardiac output.
Measured: 24 hour
Echocardiographic fractional shortening at 48 hour after randomization
Fractional shortening will be calculated on echocardiography by measuring the percentage change in the left ventricular diameter during systole at 48 hours after randomization.
Measured: 48 hour
Left ventricular end-diastolic diameter (LVEDD) on echocardiography at 48 hour after randomization
Left ventricular end-diastolic diameter (LVEDD) will be measured in millimeters by echocardiography at 48 hour after randomization
Measured: 48 hour
Left ventricular end-systolic diameter (LVESD) by echocardiography at 48 hour after randomization
Left ventricular end-systolic diameter (LVESD) will be measured in millimeters by echocardiography at 48 hour after randomization
Measured: 48 hour
Aortic diameter by echocardiography at 48 hour after randomization
Aortic diameter will be measured in millimeters by echocardiography at 48 hour after randomization
Measured: 48 hour
Velocity time integral (LVI) by echocardiography at 48 hours after randomization
Velocity time integral (LVI) be measured by echocardiography in centimeters at 48 hours after randomization to calculate the cardiac output.
Measured: 48 hour
Time taken to stop vasopressor treatment
Time taken to stop all vasopressors during hospital stay up to a maximum of 100 days
Measured: 100 days
Mortality during hospital stay
Mortality during the period of hospital stay up to a maximum of 100 days
Measured: 100 days
Serious adverse effects
Serious adverse effect with special reference to oliguria, gastrointestinal bleeds, abdominal distension, and bluish discoloration of skin and urine during hospital stay up to a maximum of 100 days
Measured: 100 days
Septic shock-related mortality
Mortality attributed to septic shock up to 7 days post-randomisation
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start15 Mar 2024 (estimated)
- Primary completion14 Mar 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Neonatal SepsisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomly allocated to an intervention arm and a placebo arm. The 2 arms of the trial will run concurrently.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sourabh Dutta, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Sourabh Dutta, MD, PhD, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306001
- Sponsor's protocol ID
- IIRP-2023-1820/F1
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized, individual patient data pertaining to publications from the study which are in the public domain will be shared with other researchers planning to conduct a study, upon reasonable written request
Publications
Hotchkiss RS, Karl IE. The pathophysiology and treatment of sepsis. N Engl J Med. 2003 Jan 9;348(2):138-50. doi: 10.1056/NEJMra021333. No abstract available.
PubMed 12519925Stolk RF, Kox M, Pickkers P. Noradrenaline drives immunosuppression in sepsis: clinical consequences. Intensive Care Med. 2020 Jun;46(6):1246-1248. doi: 10.1007/s00134-020-06025-2. Epub 2020 Apr 8. No abstract available.
PubMed 32270211Stolk RF, van der Pasch E, Naumann F, Schouwstra J, Bressers S, van Herwaarden AE, Gerretsen J, Schambergen R, Ruth MM, van der Hoeven JG, van Leeuwen H, Pickkers P, Kox M. Norepinephrine Dysregulates the Immune Response and Compromises Host Defense during Sepsis. Am J Respir Crit Care Med. 2020 Sep 15;202(6):830-842. doi: 10.1164/rccm.202002-0339OC.
PubMed 32520577Levin RL, Degrange MA, Bruno GF, Del Mazo CD, Taborda DJ, Griotti JJ, Boullon FJ. Methylene blue reduces mortality and morbidity in vasoplegic patients after cardiac surgery. Ann Thorac Surg. 2004 Feb;77(2):496-9. doi: 10.1016/S0003-4975(03)01510-8.
PubMed 14759425Ismail R, Awad H, Allam R, Youssef O, Ibrahim M, Shehata B. Methylene blue versus vasopressin analog for refractory septic shock in the preterm neonate: A randomized controlled trial. J Neonatal Perinatal Med. 2022;15(2):265-273. doi: 10.3233/NPM-210824.
PubMed 34719443Otero Luna AV, Johnson R, Funaro M, Canarie MF, Pierce RW. Methylene Blue for Refractory Shock in Children: A Systematic Review and Survey Practice Analysis. Pediatr Crit Care Med. 2020 Jun;21(6):e378-e386. doi: 10.1097/PCC.0000000000002295.
PubMed 32453920Luis-Silva F, Menegueti MG, Sato L, Peres LM, Dos Reis Sepeda C, Petroski-Moraes BC, Donadel MD, Gallo GB, Jordani MC, Mestriner F, Becari C, Basile-Filho A, Evora PRB, Martins-Filho OA, Auxiliadora-Martins M. Effect of methylene blue on hemodynamic response in the early phase of septic shock: A case series. Medicine (Baltimore). 2023 Jan 27;102(4):e32743. doi: 10.1097/MD.0000000000032743.
PubMed 36705345Ibarra-Estrada M, Kattan E, Aguilera-Gonzalez P, Sandoval-Plascencia L, Rico-Jauregui U, Gomez-Partida CA, Ortiz-Macias IX, Lopez-Pulgarin JA, Chavez-Pena Q, Mijangos-Mendez JC, Aguirre-Avalos G, Hernandez G. Early adjunctive methylene blue in patients with septic shock: a randomized controlled trial. Crit Care. 2023 Mar 13;27(1):110. doi: 10.1186/s13054-023-04397-7.
PubMed 36915146Memis D, Karamanlioglu B, Yuksel M, Gemlik I, Pamukcu Z. The influence of methylene blue infusion on cytokine levels during severe sepsis. Anaesth Intensive Care. 2002 Dec;30(6):755-62. doi: 10.1177/0310057X0203000606.
PubMed 12500513Kirov MY, Evgenov OV, Evgenov NV, Egorina EM, Sovershaev MA, Sveinbjornsson B, Nedashkovsky EV, Bjertnaes LJ. Infusion of methylene blue in human septic shock: a pilot, randomized, controlled study. Crit Care Med. 2001 Oct;29(10):1860-7. doi: 10.1097/00003246-200110000-00002.
PubMed 11588440Zhang X, Gao Y, Pan P, Wang Y, Li W, Yu X. [Methylene blue in the treatment of vasodilatory shock: a Meta-analysis]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2017 Nov;29(11):982-987. doi: 10.3760/cma.j.issn.2095-4352.2017.11.005. Chinese.
PubMed 29151412Dumbarton TC, Minor S, Yeung CK, Green R. Prolonged methylene blue infusion in refractory septic shock: a case report. Can J Anaesth. 2011 Apr;58(4):401-5. doi: 10.1007/s12630-011-9458-x. Epub 2011 Jan 19.
PubMed 21246318Zhao CC, Zhai YJ, Hu ZJ, Huo Y, Li ZQ, Zhu GJ. Efficacy and safety of methylene blue in patients with vasodilatory shock: A systematic review and meta-analysis. Front Med (Lausanne). 2022 Sep 26;9:950596. doi: 10.3389/fmed.2022.950596. eCollection 2022.
PubMed 36237547Fleischmann-Struzek C, Goldfarb DM, Schlattmann P, Schlapbach LJ, Reinhart K, Kissoon N. The global burden of paediatric and neonatal sepsis: a systematic review. Lancet Respir Med. 2018 Mar;6(3):223-230. doi: 10.1016/S2213-2600(18)30063-8.
PubMed 29508706Bentzer P, Griesdale DE, Boyd J, MacLean K, Sirounis D, Ayas NT. Will This Hemodynamically Unstable Patient Respond to a Bolus of Intravenous Fluids? JAMA. 2016 Sep 27;316(12):1298-309. doi: 10.1001/jama.2016.12310.
PubMed 27673307
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Methylene Blue for Treating Fluid-refractory, Catecholamine-resistant, Neonatal Septic Shock: a Randomized, Placebo-controlled, Superiority Trial
- ClinicalTrials.gov ID
- NCT06306001
- Acronym / sponsor ID
- IIRP-2023-1820/F1
- Conditions
- Neonatal Sepsis, Shock, Septic
- Keywords
- Methylene blue, Neonate, Septic shock, Clinical trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 14 Mar 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 12 Mar 2024 (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.
Preterm infants (born at less than 37 weeks of pregnancy) sometimes develop a serious blood infection leading to low blood pressure, which does not respond to saline or to the standard medicines for increasing blood pressure, such as dopamine and epinephrine. The goal of this research study is to compare the effect of giving an injectable medicine called Methylene blue (MB) versus not giving MB to such preterm infants who are unresponsive to standard treatment. The main questions that this study aims to answer is:
- Whether MB treatment reduces death to any cause as compared to no MB treatment.
- Whether treatment with MB reduces the time to achieve normal blood pressure
- Whether treatment with MB reduces the time to stoppage of all blood pressure medications, steroids and normal saline.
- Whether treatment with MB improves heart function as measured by echocardiography at 24 and 48 hours.
Detailed description
Preterm infants with definite or probable sepsis and fluid-refractory, catecholamine-resistant septic shock will be eligible for enrolment if they have no contraindication to receive MB. After obtaining parental consent, they will be stratified as per the first-line catecholamine used and randomly allocated to receive MB (bolus followed by infusion) or no MB for 24 hours. They will be observed for all-cause mortality (primary outcome), cause-specific mortality, time to achieve hemodynamic stability and adverse effects (secondary outcomes) over a 7-day period, all-cause mortality and cause-specific mortality hospital stay and duration of hospital stay.
The main questions it aims to answer are
- To determine whether treatment with intravenous MB therapy reduces all-cause mortality when compared to no MB treatment, among preterm neonates with catecholamine-resistant septic shock
- To compare the time to achieve therapeutic endpoints among preterm neonates with catecholamine-resistant septic shock treated with intravenous MB versus no MB
- To compare time to stoppage of all inotrope/vasopressor treatment among preterm neonates with catecholamine-resistant septic shock treated with intravenous MB versus no MB
- To compare echocardiographic parameters (at 24 hours after randomization) among preterm neonates with catecholamine-resistant septic shock treated with intravenous MB versus no MB
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomly allocated to an intervention arm and a placebo arm. The 2 arms of the trial will run concurrently.
| Arm | Type | Receives |
|---|---|---|
| Methylene blue | Experimental | Drug: Methylene BlueSubjects in the intervention arm will receive a 1 mg/kg bolus of methylene blue over 30 minutes, followed by an infusion of 0.15 mg/kg/h. The infusion rate may be increased in steps of 0.15 mg/kg/h every 30 minutes until a maximum of 0.5 mg/kg/h. |
| Placebo infusion | Placebo comparator | Other: PlaceboSubjects in the control arm will receive a placebo infusion (normal saline) at the same volumetric rate. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- G6PD deficient or family history of G6PD deficiency
- Potentially lethal malformation
- Congenital heart disease
- Severe acute kidney injury
- Family history of allergy to methylene blue or food dyes
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 |
|---|---|---|
| Methylene BlueAlso: MBSubjects in the intervention arm will receive a 1 mg/kg bolus of methylene blue over 30 minutes, followed by an infusion of 0.15 mg/kg/h. The infusion rate may be increased in steps of 0.15 mg/kg/h every 30 minutes until a maximum of 0.5 mg/kg/h. | Drug | Methylene blue |
| PlaceboAlso: Normal salineSubjects in the placebo arm will receive normal saline in the same volumetric dose as methylene blue in the intervention arm | Other | Placebo infusion |
Primary outcome
All-cause mortality within 7 days after randomization
Time frame: 7 days
Mortality due to any cause over 7 days after randomization
16 secondary outcomes
Time taken to achieve therapeutic end-points within 7 days after randomization
Time frame: 7 days
Time taken to stop all inotrope/vasopressor treatment within 7 days after randomisation
Time frame: 7 days
Echocardiographic fractional shortening at 24 hour after randomization
Time frame: 24 hour
Left ventricular end-diastolic diameter (LVEDD) by echocardiography at 24 hour after randomization
Time frame: 24 hour
Left ventricular end-systolic diameter (LVESD) by echocardiography at 24 hour after randomization
Time frame: 24 hour
Aortic diameter by echocardiography at 24 hour after randomization
Time frame: 24 hour
Velocity time integral (LVI) by echocardiography at 24 hours after randomization
Time frame: 24 hour
Echocardiographic fractional shortening at 48 hour after randomization
Time frame: 48 hour
Left ventricular end-diastolic diameter (LVEDD) on echocardiography at 48 hour after randomization
Time frame: 48 hour
Left ventricular end-systolic diameter (LVESD) by echocardiography at 48 hour after randomization
Time frame: 48 hour
Aortic diameter by echocardiography at 48 hour after randomization
Time frame: 48 hour
Velocity time integral (LVI) by echocardiography at 48 hours after randomization
Time frame: 48 hour
Time taken to stop vasopressor treatment
Time frame: 100 days
Mortality during hospital stay
Time frame: 100 days
Serious adverse effects
Time frame: 100 days
Septic shock-related mortality
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Results publication: PubMed 12519925Hotchkiss RS, Karl IE. The pathophysiology and treatment of sepsis. N Engl J Med. 2003 Jan 9;348(2):138-50. doi: 10.1056/NEJMra021333. No abstract available.
- Results publication: PubMed 32270211Stolk RF, Kox M, Pickkers P. Noradrenaline drives immunosuppression in sepsis: clinical consequences. Intensive Care Med. 2020 Jun;46(6):1246-1248. doi: 10.1007/s00134-020-06025-2. Epub 2020 Apr 8. No abstract available.
- Results publication: PubMed 32520577Stolk RF, van der Pasch E, Naumann F, Schouwstra J, Bressers S, van Herwaarden AE, Gerretsen J, Schambergen R, Ruth MM, van der Hoeven JG, van Leeuwen H, Pickkers P, Kox M. Norepinephrine Dysregulates the Immune Response and Compromises Host Defense during Sepsis. Am J Respir Crit Care Med. 2020 Sep 15;202(6):830-842. doi: 10.1164/rccm.202002-0339OC.
- Results publication: PubMed 14759425Levin RL, Degrange MA, Bruno GF, Del Mazo CD, Taborda DJ, Griotti JJ, Boullon FJ. Methylene blue reduces mortality and morbidity in vasoplegic patients after cardiac surgery. Ann Thorac Surg. 2004 Feb;77(2):496-9. doi: 10.1016/S0003-4975(03)01510-8.
- Results publication: PubMed 34719443Ismail R, Awad H, Allam R, Youssef O, Ibrahim M, Shehata B. Methylene blue versus vasopressin analog for refractory septic shock in the preterm neonate: A randomized controlled trial. J Neonatal Perinatal Med. 2022;15(2):265-273. doi: 10.3233/NPM-210824.
- Results publication: PubMed 32453920Otero Luna AV, Johnson R, Funaro M, Canarie MF, Pierce RW. Methylene Blue for Refractory Shock in Children: A Systematic Review and Survey Practice Analysis. Pediatr Crit Care Med. 2020 Jun;21(6):e378-e386. doi: 10.1097/PCC.0000000000002295.
- Results publication: PubMed 36705345Luis-Silva F, Menegueti MG, Sato L, Peres LM, Dos Reis Sepeda C, Petroski-Moraes BC, Donadel MD, Gallo GB, Jordani MC, Mestriner F, Becari C, Basile-Filho A, Evora PRB, Martins-Filho OA, Auxiliadora-Martins M. Effect of methylene blue on hemodynamic response in the early phase of septic shock: A case series. Medicine (Baltimore). 2023 Jan 27;102(4):e32743. doi: 10.1097/MD.0000000000032743.
- Results publication: PubMed 36915146Ibarra-Estrada M, Kattan E, Aguilera-Gonzalez P, Sandoval-Plascencia L, Rico-Jauregui U, Gomez-Partida CA, Ortiz-Macias IX, Lopez-Pulgarin JA, Chavez-Pena Q, Mijangos-Mendez JC, Aguirre-Avalos G, Hernandez G. Early adjunctive methylene blue in patients with septic shock: a randomized controlled trial. Crit Care. 2023 Mar 13;27(1):110. doi: 10.1186/s13054-023-04397-7.
- Results publication: PubMed 12500513Memis D, Karamanlioglu B, Yuksel M, Gemlik I, Pamukcu Z. The influence of methylene blue infusion on cytokine levels during severe sepsis. Anaesth Intensive Care. 2002 Dec;30(6):755-62. doi: 10.1177/0310057X0203000606.
- Results publication: PubMed 11588440Kirov MY, Evgenov OV, Evgenov NV, Egorina EM, Sovershaev MA, Sveinbjornsson B, Nedashkovsky EV, Bjertnaes LJ. Infusion of methylene blue in human septic shock: a pilot, randomized, controlled study. Crit Care Med. 2001 Oct;29(10):1860-7. doi: 10.1097/00003246-200110000-00002.
- Results publication: PubMed 29151412Zhang X, Gao Y, Pan P, Wang Y, Li W, Yu X. [Methylene blue in the treatment of vasodilatory shock: a Meta-analysis]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2017 Nov;29(11):982-987. doi: 10.3760/cma.j.issn.2095-4352.2017.11.005. Chinese.
- Results publication: PubMed 21246318Dumbarton TC, Minor S, Yeung CK, Green R. Prolonged methylene blue infusion in refractory septic shock: a case report. Can J Anaesth. 2011 Apr;58(4):401-5. doi: 10.1007/s12630-011-9458-x. Epub 2011 Jan 19.
- Global report on the epidemiology and burden of sepsis \[Internet\]. 2020Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized, individual patient data pertaining to publications from the study which are in the public domain will be shared with other researchers planning to conduct a study, upon reasonable written request
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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.
Sourabh Dutta, MD, PhD principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Methylene Blue in people with Neonatal Sepsis and Shock, Septic, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 0 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: opening soon, as of the sponsor's last update on 12 Mar 2024. 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 India. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sourabh Dutta, MD, PhD (+91-1722755313, sourabhdutta1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality within 7 days after randomization (time frame: 7 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 NCT06306001, which also lists 24 linked publications.
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 12 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.