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

Last updated: September 30, 2019
Sponsor: Ain Shams University
Overall Status: Active - Recruiting

Phase

2

Condition

Low Blood Pressure (Hypotension)

Treatment

N/A

Clinical Study ID

NCT04110418
FWA000017586
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Neonate with Gestational age at birth ≤ 36weeks Inclusion Criteria:

  • diagnosis of Septic shock according to clinical sepsis score of Tollner andHematologic Scoring System of Rodwell

  • Refractory septic shock defined as hypotension although adequate fluid resuscitate andhigh dose vasopressor(NE >0.5 mcg/kg/min)

  • consent form

Exclusion

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,andSerotonin-Norepinephrine Reuptake Inhibitors

Study Design

Total Participants: 36
Study Start date:
February 19, 2019
Estimated Completion Date:
February 19, 2020

Study 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

Connect with a study center

  • Neonatal Intensive Care Units (NICUs), Ain Shams University

    Cairo, Abbasia 1234
    Egypt

    Active - Recruiting

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