Neonatal SepsisPhase 2NCT04110418
Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate
A Phase 2 study testing Methylene Blue in people with Neonatal Sepsis and Refractory Shock, run by Ain Shams University at 1 site in Egypt.
Trial summary
A randomized, prospective study comparing methylene blue versus terlipressin in treatment of catecholamines resistant shock in preterm neonate Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neonatal Sepsis, Refractory Shock
- What is being tested?
- Methylene Blue
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Feb 2019to 19 Feb 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Neonatal Intensive Care Units (NICUs), Ain Shams University
Cairo, Abbasia, 1234
rabab allam, physician, 01119069425 ext. 202, dr_rabab_asu@hotmail.com
About this study
A randomized, prospective study comparing methylene blue versus terlipressin in treatment of catecholamines resistant shock in preterm neonate
Read the 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
- Being tested
- Methylene Blue
- Keywords
- methylene blue, terlipressin, septic shock, preterm neonate
- Medical subject headings
- Neonatal Sepsis, Shock, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene BlueDrug
Also called terlipressin acetate
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Methylene Blue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24hours
Secondary outcomes (1)
to assess the effect of intervention on survival
mortality rate
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start19 Feb 2019
- Primary completion19 Feb 2020 (estimated)
- Study completion19 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal SepsisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabab Gameel Abd EL hamid allam, Ain Shams University
- Investigators
- rabab allam, physician, Principal investigator, ain shams university faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110418
- Sponsor's protocol ID
- FWA000017586
- Status last verified
- Sep 2019
- First submitted
- 26 Sep 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate
- ClinicalTrials.gov ID
- NCT04110418
- Acronym / sponsor ID
- FWA000017586
- Conditions
- Neonatal Sepsis, Refractory Shock
- Keywords
- methylene blue, terlipressin, septic shock, preterm neonate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 19 Feb 2020 (estimated)
- Study completion
- 19 Feb 2020 (estimated)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylene Blue group (Group MB) | Active comparator | Drug: Methylene BlueMethylene 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. |
| Terlipressin Group (Group TP ) | Placebo comparator | Drug: Methylene BlueThe 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylene BlueAlso: terlipressin acetateMethylene 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 | Drug | Methylene Blue group (Group MB), Terlipressin Group (Group TP ) |
Primary outcome
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
1 secondary outcome
to assess the effect of intervention on survival
Time frame: 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
rabab allam, physician principal investigator
ain shams university faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylene Blue in people with Neonatal Sepsis and Refractory Shock, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rabab allam, physician (01119069425 ext. 202, dr_rabab_asu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to assess the efficancy of each intervention in improving hemodymaic status: time taken to reach adequate mean blood pressure (time frame: 24hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.