Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock

Launched by POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH · Mar 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medicine called Methylene Blue (MB) on preterm infants (babies born before 37 weeks of pregnancy) who are suffering from a serious condition known as septic shock, which is a severe blood infection that causes dangerously low blood pressure. The main goal is to find out if MB can help these babies recover better than if they do not receive this treatment. The researchers will look at whether MB reduces the risk of death, helps restore normal blood pressure faster, allows for quicker discontinuation of other medications, and improves heart function within the first two days of treatment.

To participate in this study, infants must be diagnosed with septic shock and not responding to standard treatments, including certain fluids and medications to raise blood pressure. Eligible infants are those who are less than 28 days old and were born preterm. However, some conditions, such as certain genetic disorders or severe heart issues, may prevent a baby from being included in the trial. Families should know that this study is not yet recruiting participants, but it aims to provide important insights that could help improve treatment for these vulnerable infants in the future.

Gender

ALL

Eligibility criteria

• • Screening Criteria: preterm infants (\<37 weeks, \<28 days) clinically diagnosed to have septic shock will be screened for inclusion Inclusion criteria: Subjects must fulfill all the following
• • 1. Definite/probable sepsis :Clinical syndrome of sepsis for which bedside neonatologist starts intravenous antibiotics AND either a positive culture of otherwise sterile body fluid OR presence of any 2 or more of the following five markers of sepsis: (a) C-reactive protein \>10 mg/dL; (b) procalcitonin as per age-appropriate cut-off (c) total leukocyte count and absolute neutrophilic count beyond acceptable range (d) chest X-ray adjudged as pneumonia by two independent Neonatologists.
• • 2. Shock: adapted from the definition given by Davis et al 2017
• • 1. Either SBP \< age and gestation appropriate cut-off OR
• • 2. Presence of any 2 of the following 6 parameters i. HR \>205/min ii. Central pulses either week OR bounding iii. CRT \>3 sec OR flash refill (\<1 sec) iv. skin mottled/cool OR flushed v. urine output \<0.5 ml/kg/h in the preceding 6 hours vi. DBP \< age and gestation appropriate cut-off
• • 3. Fluid and catecholamine-resistant shock: received fluid boluses up to a maximum of 40 ml/kg followed by catecholamine infusion titrated up to the maximum dose. The catecholamine infusion could be either dopamine (maximum dose 20 µg/kg/min) or epinephrine (maximum dose 0.4 µg/kg/min) or norepinephrine (maximum dose 0.4 µg/kg/min).
• Exclusion Criteria:
• excluded if ≥1 criterion positive:
• • 1. G6PD deficient or family history of G6PD deficiency
• • 2. Potentially lethal malformation
• • 3. Congenital heart disease
• • 4. Severe acute kidney injury
• • 5. Family history of allergy to methylene blue or food dyes