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

NCT ID: NCT04110418

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-19
• Study Completion Date: 2020-02-19

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

Conditions

Neonatal Sepsis; Refractory Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Methylene Blue group (Group MB)

Methylene Blue is supplied in 1 ml or 10 mL single-dose ampules. Each 1 mL ampule contains 10 mg of methylene blue as a clear dark blue solution

• Any unused product or waste material should be disposed of in accordance with local practice,
• For administration to be diluted before use in a solution of 50 mL 5% Dextrose in Water (D5W) in order to avoid local pain, particularly in the paediatric population. Use the diluted solution immediately after preparation.
• Do not mix with sodium chloride 9 mg/mL (0.9%) solution for injection, because it has been demonstrated that chloride reduces the solubility of methylene blue.

Group Type: ACTIVE_COMPARATOR

Methylene Blue

Intervention Type: 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

Terlipressin Group (Group TP )

The active substance is terlipressin acetate. Each ampoule contains

1 mg of terlipressin acetate in 8.5 ml solution for injection. This is equivalent to 0.12 mg terlipressin acetate per ml.

• The powder is to be dissolved in the enclosed solvent and slowly administered intravenously. Further dilution up to 10 ml with sterile isotonic sodium chloride solution is possible.
• Store in a refrigerator at 2-8˚C.
• Keep the ampoules in the outer carton in order to protect from light

Group Type: PLACEBO_COMPARATOR

Methylene Blue

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

terlipressin acetate

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Rabab Gameel Abd EL hamid allam

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

rabab allam, physician

Role: PRINCIPAL_INVESTIGATOR

ain shams university faculty of medicine

Locations

Neonatal Intensive Care Units (NICUs), Ain Shams University

Cairo, Abbasia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

rabab allam, physician

Role: CONTACT

dr_rabab_asu@hotmail.com

01119069425 ext. 202

Facility Contacts

rabab allam, physician

Role: primary

dr_rabab_asu@hotmail.com

01119069425 ext. 202

Other Identifiers

FWA000017586

Identifier Type: -

Identifier Source: org_study_id