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

Neonatal Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04110418
• Other study ID #: FWA000017586
• Status: Recruiting
• Phase: Phase 2
• Start date: February 19, 2019
• Est. completion date: February 19, 2020

Study information

• Verified date: September 2019
• Source: Ain Shams University
• Contact: rabab allam, physician
• Phone: 01119069425
• Email: dr_rabab_asu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: February 19, 2020
• Est. primary completion date: February 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Sepsis
• Refractory Shock
• Shock
• Shock, Septic

Intervention

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

Locations

Country	Name	City	State
Egypt	Neonatal Intensive Care Units (NICUs), Ain Shams University	Cairo	Abbasia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to assess the efficancy of each intervention in improving hemodymaic status: time taken to reach adequate mean blood pressure	The time taken to reach adequate mean blood pressure; Reduction in the dosage of the standard inotropic support	24hours
Secondary	to assess the effect of intervention on survival	mortality rate	4 days