SepsisPhase 4NCT02910765
Methylene Blue and Ozone in Early Sepsis
A Phase 4 study testing methylene blue, ozone and saline infusion in people with Sepsis, run by Assiut University.
Trial summary
effects of methylene blue and ozone O3 therapy effects in early sepsis management , and their implications upon outcome Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Sepsis
- What is being tested?
- methylene blue, ozone and saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Apr 2017
- Phase
- Phase 4
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- early sepsis Adults patients
Who cannot join
- cardiac problems Glucose-6-Phosphate-Dehydrogenase Insufficiency Ozone Allergy Recent Myocardial Infarction Active Hyperthyroidism Thrombocytopenia Pregnancy Contraindications
Trial locations and contacts
No sites are listed yet.
Abdelraheem Elawamy, MD contact
About this study
Official title: Methylene Blue and Ozone in Early Sepsis , a Randomized Double Blind Trial
effects of methylene blue and ozone O3 therapy effects in early sepsis management , and their implications upon outcome
Read the detailed description
effects of methylene blue on inducible nitric oxide messenger RNA transcription and protein expression are well evident in vasoplegia ,and septic shock . In the same time , ozone O3 therapy is also valuable in immune-modulation in multiple pathologies . our study collaborate both methylene blue and Ozone in early sepsis management , and we will evaluate the global medical progress , ICU stay , Morbidity and mortality
- Conditions
- Sepsis
- Being tested
- methylene blue, ozone, saline infusion, oxygen
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylene blueDrug
ozoneDrug
saline infusionOther
oxygenOther
| Study group | Role | What they receive |
|---|---|---|
| M methylene blue and ozone | Active comparator | intravenous methylene blue and blood mixed with ozone ozone injection in early sepsis patients Receives: Drug: methylene blue; Drug: ozone |
| P Placebo | Placebo comparator | saline and oxygen mixed blood injection in early sepsis patients Receives: Other: saline infusion; Other: oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
APACHE score
Measured: 7 days
Secondary outcomes (1)
ICU stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Zarief , MD, Assiut University
- Investigators
- Emad Zarief K Said, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910765
- Sponsor's protocol ID
- IRB00009906
- Status last verified
- Sep 2016
- First submitted
- 20 Sep 2016
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylene Blue and Ozone in Early Sepsis , a Randomized Double Blind Trial
- ClinicalTrials.gov ID
- NCT02910765
- Acronym / sponsor ID
- IRB00009906
- Conditions
- Sepsis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 22 Sep 2016 (estimated)
- 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.
effects of methylene blue and ozone O3 therapy effects in early sepsis management , and their implications upon outcome
Detailed description
effects of methylene blue on inducible nitric oxide messenger RNA transcription and protein expression are well evident in vasoplegia ,and septic shock . In the same time , ozone O3 therapy is also valuable in immune-modulation in multiple pathologies . our study collaborate both methylene blue and Ozone in early sepsis management , and we will evaluate the global medical progress , ICU stay , Morbidity and mortality
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M methylene blue and ozone | Active comparator | Drug: methylene blue, Drug: ozoneintravenous methylene blue and blood mixed with ozone ozone injection in early sepsis patients |
| P Placebo | Placebo comparator | Other: saline infusion, Other: oxygensaline and oxygen mixed blood injection in early sepsis patients |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- early sepsis Adults patients
Key exclusion criteria (1 listed)
- cardiac problems Glucose-6-Phosphate-Dehydrogenase Insufficiency Ozone Allergy Recent Myocardial Infarction Active Hyperthyroidism Thrombocytopenia Pregnancy Contraindications
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 blue | Drug | M methylene blue and ozone |
| ozone | Drug | M methylene blue and ozone |
| saline infusion | Other | P Placebo |
| oxygen | Other | P Placebo |
Primary outcome
APACHE score
Time frame: 7 days
1 secondary outcome
ICU stay
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Abdelraheem Elawamy, MD contact
Emad Zarief K Said, MD principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing methylene blue, ozone and saline infusion in people with Sepsis, run by Assiut University.
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 1 inclusion and 1 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 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Emad Zarief K. Said, MD (00201007046058, emadzarief@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
APACHE score (time frame: 7 days). 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 22 Sep 2016.