Status
Unknown
Phase
Phase 2
Enrollment
36
Locations
1
Results
Not posted
Publications
0
Study summary
A randomized, prospective study comparing methylene blue versus terlipressin in treatment of catecholamines resistant shock in preterm neonate
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
DRUG
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
First posted
Oct 1, 2019
Study start
Feb 19, 2019
Primary completion
Feb 19, 2020
Study completion
Feb 19, 2020
Results posted
Not reported
Registry updated
Oct 1, 2019
Outcomes
to assess the efficancy of each intervention in improving hemodymaic status: time taken to reach adequate mean blood pressure
Time frame · 24hours
The time taken to reach adequate mean blood pressure Reduction in the dosage of the standard inotropic support
to assess the effect of intervention on survival
Time frame · 4 days
mortality rate
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
Study locations
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Neonatal Intensive Care Units (NICUs), Ain Shams University
Cairo, Abbasia, Egypt
Publications
No PMID-linked publications were present in this registry snapshot.
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