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

Primary Purpose

Neonatal Sepsis, Refractory Shock

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Methylene Blue
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Sepsis focused on measuring methylene blue, terlipressin, septic shock, preterm neonate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neonatal Intensive Care Units (NICUs), Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Methylene Blue group (Group MB)

Terlipressin Group (Group TP )

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

to assess the effect of intervention on survival
mortality rate

Full Information

First Posted
September 26, 2019
Last Updated
September 30, 2019
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04110418
Brief Title
Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate
Official Title
Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 19, 2019 (Actual)
Primary Completion Date
February 19, 2020 (Anticipated)
Study Completion Date
February 19, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Sepsis, Refractory Shock
Keywords
methylene blue, terlipressin, septic shock, preterm neonate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methylene Blue group (Group MB)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Terlipressin Group (Group TP )
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Methylene Blue
Other Intervention Name(s)
terlipressin acetate
Intervention Description
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
Primary Outcome Measure Information:
Title
to assess the efficancy of each intervention in improving hemodymaic status: time taken to reach adequate mean blood pressure
Description
The time taken to reach adequate mean blood pressure Reduction in the dosage of the standard inotropic support
Time Frame
24hours
Secondary Outcome Measure Information:
Title
to assess the effect of intervention on survival
Description
mortality rate
Time Frame
4 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
rabab allam, physician
Phone
01119069425
Ext
202
Email
dr_rabab_asu@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
rabab allam, physician
Organizational Affiliation
ain shams university faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neonatal Intensive Care Units (NICUs), Ain Shams University
City
Cairo
State/Province
Abbasia
ZIP/Postal Code
1234
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
rabab allam, physician
Phone
01119069425
Ext
202
Email
dr_rabab_asu@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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