Status:
UNKNOWN
Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate
Lead Sponsor:
Ain Shams University
Conditions:
Neonatal Sepsis
Refractory Shock
Eligibility:
All Genders
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Neonate with Gestational age at birth ≤ 36weeks
- 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
- 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
Key Trial Info
Start Date :
February 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 19 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04110418
Start Date
February 19 2019
End Date
February 19 2020
Last Update
October 1 2019
Active Locations (1)
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1
Neonatal Intensive Care Units (NICUs), Ain Shams University
Cairo, Abbasia, Egypt, 1234