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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110418
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Rabab Gameel Abd EL hamid allam, Ain Shams University

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

Condition or disease Intervention/treatment Phase
Neonatal Sepsis Refractory Shock Drug: Methylene Blue Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : February 19, 2020
Estimated Study Completion Date : February 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

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 Name: 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 Name: terlipressin acetate




Primary Outcome Measures :
  1. to assess the efficancy of each intervention in improving hemodymaic status: time taken to reach adequate mean blood pressure [ Time Frame: 24hours ]

    The time taken to reach adequate mean blood pressure

    Reduction in the dosage of the standard inotropic support



Secondary Outcome Measures :
  1. to assess the effect of intervention on survival [ Time Frame: 4 days ]
    mortality rate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110418


Contacts
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Contact: rabab allam, physician 01119069425 ext 202 dr_rabab_asu@hotmail.com

Locations
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Egypt
Neonatal Intensive Care Units (NICUs), Ain Shams University Recruiting
Cairo, Abbasia, Egypt, 1234
Contact: rabab allam, physician    01119069425 ext 202    dr_rabab_asu@hotmail.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: rabab allam, physician ain shams university faculty of medicine
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Responsible Party: Rabab Gameel Abd EL hamid allam, Assistant lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT04110418    
Other Study ID Numbers: FWA000017586
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rabab Gameel Abd EL hamid allam, Ain Shams University:
methylene blue
terlipressin
septic shock
preterm neonate
Additional relevant MeSH terms:
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Shock, Septic
Neonatal Sepsis
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Infant, Newborn, Diseases
Terlipressin
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Vasoconstrictor Agents