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

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

Study Overview

• Status: Unknown
• Conditions: Neonatal Sepsis; Refractory Shock
• Intervention / Treatment: Drug: Methylene Blue

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

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: rabab allam, physician; Phone Number: 202 01119069425; Email: dr_rabab_asu@hotmail.com

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt, 1234
      • Recruiting
      • Neonatal Intensive Care Units (NICUs), Ain Shams University
      • Contact: rabab allam, physician; Phone Number: 202 01119069425; Email: dr_rabab_asu@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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; Other Names: terlipressin acetate
Placebo Comparator: 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	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; Other Names: terlipressin acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: rabab allam, physician, Ain Shams University Faculty Of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2019
• Primary Completion (Anticipated): February 19, 2020
• Study Completion (Anticipated): February 19, 2020

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: septic shock; terlipressin; methylene blue; preterm neonate
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Shock, Septic; Shock; Neonatal Sepsis; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Vasoconstrictor Agents; Methylene Blue; Terlipressin
• Other Study ID Numbers: FWA000017586

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No