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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04110418

Enrollment

Registered

2019-10-01

Start date

2019-02-19

Completion date

2020-02-19

Last updated

2019-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Sepsis, Refractory Shock

Keywords

methylene blue, terlipressin, septic shock, preterm neonate

Brief 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

Interventions

DRUGMethylene 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
to assess the efficancy of each intervention in improving hemodymaic status: time taken to reach adequate mean blood pressure	24hours	The time taken to reach adequate mean blood pressure Reduction in the dosage of the standard inotropic support

Secondary

Measure	Time frame	Description
to assess the effect of intervention on survival	4 days	mortality rate

Countries

Egypt

Contacts

Primary Contactrabab allam, physician

dr_rabab_asu@hotmail.com01119069425

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026