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

NCT04110418 | Unknown Phase 2

• 1 other identifier: FWA000017586
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neonatal Sepsis; Refractory Shock

Keywords

methylene blue; terlipressin; septic shock; preterm neonate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• to assess the effect of intervention on survival

  4 days

Study Arms (2)

Methylene Blue group (Group MB)

ACTIVE COMPARATOR

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

Terlipressin Group (Group TP )

PLACEBO COMPARATOR

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

Interventions

Methylene Blue 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

Also known as: terlipressin acetate

Methylene Blue group (Group MB); Terlipressin Group (Group TP )

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Neonatal Intensive Care Units (NICUs), Ain Shams University

Cairo, Abbasia, 1234, Egypt

RECRUITING

MeSH Terms

Conditions

Neonatal Sepsis; Shock; Shock, Septic

Interventions

Methylene Blue; Terlipressin

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• rabab allam, physician

  ain shams university faculty of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

rabab allam, physician

CONTACT

01119069425; dr_rabab_asu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 1, 2019
• Study Start: February 19, 2019
• Primary Completion: February 19, 2020
• Study Completion: February 19, 2020
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

EG (1)