Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate

Ain Shams University

Status and phase: Unknown; Phase 2

Conditions: Neonatal Sepsis; Refractory Shock

Treatments: Drug: Methylene Blue

Study type: Interventional

Funder types: Other

Identifiers

NCT04110418

FWA000017586

Details and patient eligibility

About

A randomized, prospective study comparing methylene blue versus terlipressin in treatment of catecholamines resistant shock in preterm neonate

Full description

The study will be an un-blinded, Phase 2, randomized, 1:1, prospective trial comparing methylene blue versus terlipressin in treatment of preterm neonate with catecholamines resistant septic shock the outcome as regard elevation of mean arterial blood pressure will be measured within 72 hours

Enrollment: 36 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Neonate with Gestational age at birth ≤ 36weeks

Inclusion Criteria:

• diagnosis of Septic shock according to clinical sepsis score of Tollner and Hematologic Scoring System of Rodwell
• Refractory septic shock defined as hypotension although adequate fluid resuscitate and high dose vasopressor(NE >0.5 mcg/kg/min)
• consent form

Exclusion Criteria:

• known case of G6pd deficiency
• Hx of drug allergy MB, NE, terlipressin
• Patients with severely impaired renal function.
• History of maternal drug intake of selective serotonin reuptake inhibitors,and Serotonin-Norepinephrine Reuptake Inhibitors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups, including a placebo group

Methylene Blue group (Group MB)

Active Comparator group

Description:

Methylene Blue is supplied in 1 ml or 10 mL single-dose ampules. Each 1 mL ampule contains 10 mg of methylene blue as a clear dark blue solution * Any unused product or waste material should be disposed of in accordance with local practice, * For administration to be diluted before use in a solution of 50 mL 5% Dextrose in Water (D5W) in order to avoid local pain, particularly in the paediatric population. Use the diluted solution immediately after preparation. * Do not mix with sodium chloride 9 mg/mL (0.9%) solution for injection, because it has been demonstrated that chloride reduces the solubility of methylene blue.

Treatment:

Drug: Methylene Blue

Terlipressin Group (Group TP )

Placebo Comparator group

Description:

The active substance is terlipressin acetate. Each ampoule contains 1 mg of terlipressin acetate in 8.5 ml solution for injection. This is equivalent to 0.12 mg terlipressin acetate per ml. * The powder is to be dissolved in the enclosed solvent and slowly administered intravenously. Further dilution up to 10 ml with sterile isotonic sodium chloride solution is possible. * Store in a refrigerator at 2-8˚C. * Keep the ampoules in the outer carton in order to protect from light

Treatment:

Drug: Methylene Blue