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Effect of methylene blue(drug used in very low blood pressure) in critically ill patients

EFFECT OF EARLY USE OF METHYLENE BLUE AND VASOPRESSIN ON THE DOSE OF NORADRENALINE FOR MANAGEMENT OF SEPTIC SHOCK: A RANDOMIZED CONTROL STUDY - BLUE SHOCK

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038542
Enrollment
74
Registered
2021-12-09
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z00-Z99- Factors influencing health status and contact with health services

Interventions

Intervention1: Methylene blue: Methylene blue (MB) is a reduction agent traditionally used in the treatment of methemoglobinaemia, however, it has been increasingly used in the management of refractor

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients older than 18 years diagnosed with septic shock during their ICU stay whose relatives give informed consent for the study will be considered for enrolment. Within 24hrs of septic shock

Exclusion criteria

Exclusion criteria: Patients whose relatives refuse to give consent for the study. Unstable coronary artery syndrome (acute myocardial infarction during this episode of shock based on the combination of history, electrocardiogram and enzyme changes) or underlying cardiac dysfunction [cardiac index (CI) Stroke or head injury. Chronic renal failure on maintenance dialysis. Malignancy or other irreversible disease or condition for which mortality was estimated to be very high (defined by investigator), Acute mesenteric ischemia either proven or suspected Raynaudâ??s phenomenon Pregnancy Organ transplantation. Known hypersensitivity to norepinephrine or methylene blue -G 6PD deficiency.

Design outcomes

Primary

MeasureTime frame
To study the dose of Norepinephrine required to achieve target MAP(65-70mm of Hg) after 6,12 and 24 hours of starting the infusion.Timepoint: To study the dose of Norepinephrine required to achieve target MAP(65-70mm of Hg) after 6,12 and 24 hours of starting the infusion.

Secondary

MeasureTime frame
Duration of vasopressor requirement. Changes in lactate level at 6,12 and 24 hours after starting the infusion. Urine output in ml per hour at 6,12 and 24 hours after starting of infusion. Mortality during the ICU stay after starting Methylene blue or Vasopressin. Changes in the Sequential Organ Failure Assessment (SOFA) score after 6,12 and 24 hours of starting vasopressor infusion.Timepoint: Duration of vasopressor requirement. Changes in lactate level at 6,12 and 24 hours after starting the infusion. Urine output in ml per hour at 6,12 and 24 hours after starting of infusion. Mortality during the ICU stay after starting Methylene blue or Vasopressin. Changes in the Sequential Organ Failure Assessment (SOFA) score after 6,12 and 24 hours of starting vasopressor infusion.

Countries

India

Contacts

Public ContactHarshavardhan R KURI

AIIMS JODHPUR

ankuranaesthesia@gmail.com9654045653

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026