NCT04110418

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Neonatal Sepsis
• Refractory Shock

Interventions

Type	Name	Description
DRUG	Methylene Blue	Methylene Blue group (Group MB):will receive IV MB initiated with a first loading dose ( 1 mg/kg over 30 minutes ) then continuous IV infusion( 0.15 mg/kg per hour for up to 24 hours) Terlipressin Group (Group TP) Terlipressin will be initiated with a loading dose ( 2 μg/kg intravenous over 30 minutes ) followed by continuous IV infusion starting by 2 μg/kg/h escalating up every 15 minutes up to 20 μg/kg/h

Timeline

• Start date: 2019-02-19
• Primary completion: 2020-02-19
• Completion: 2020-02-19
• First posted: 2019-10-01
• Last updated: 2019-10-01

Locations

1 site across 1 country: Egypt