Septic ShockPhase 2NCT06592547
Intravenous Metoprolol in Septic Shock
A Phase 2 study testing Intravenous metoprolol tartrate in people with Septic Shock and Ventilator Acquired Pneumonia, run by Alexandria University at 1 site in Egypt.
Trial summary
A RCT designed to assess the effect of giving intravenous beta-blockers in patients with septic shock after achieving hemodynamic stability. The principle of this study is to control heart rate allowing for better diastolic filling and thus better perfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Ventilator Acquired Pneumonia
- What is being tested?
- Intravenous metoprolol tartrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 10 Nov 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study population included adult patients (≥ 18 years) diagnosed with septic shock secondary to VAP with sinus tachycardia, from April 1, 2022, to April 31, 2023. Septic shock was defined according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). VAP was identified as per the guidelines provided by the American Thoracic Society and Infectious Diseases Society of America.
Who cannot join
- Patients were excluded if they had contraindications to beta-blockers, had a history of heart failure, or had been receiving beta-blockers prior to the septic shock. Patients were also excluded if they developed complications from beta- blockers administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECT of INTRAVENOUS METOPROLOL TARTRATE on MORTALITY in PATIENTS with SEPTIC SHOCK DUE to VENTILATOR-ASSOCIATED PNEUMONIA Thesis
A RCT designed to assess the effect of giving intravenous beta-blockers in patients with septic shock after achieving hemodynamic stability. The principle of this study is to control heart rate allowing for better diastolic filling and thus better perfusion.
Read the detailed description
A RCT, conducted at alexandria main university hospital, patients were divided into 2 groups, Control group which received the standard care for septic shock and metoprolol group which recieved intravenous metoprolol then patients were assessed for Blood pressure, heart rate, iv fluids needed, vasopressor doses and 28 days mortality
- Conditions
- Septic Shock, Ventilator Acquired Pneumonia
- Being tested
- Intravenous metoprolol tartrate, Standard Care (in control arm)
- Keywords
- Beta blockers, septic shock, Rate control, mortality
- Medical subject headings
- Shock, Septic, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous metoprolol tartrateDrug
An intravenous beta-blockers, recieved FDA approval
Standard Care (in control arm)Other
Standard care according to surviving sepsis campaign
| Study group | Role | What they receive |
|---|---|---|
| Metoprolol group | Active comparator | The group that received intravenous metoprolol Receives: Drug: Intravenous metoprolol tartrate |
| Control group | Placebo comparator | The group that received standard care Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day Mortality
Measured: 28 days
Secondary outcomes (3)
ICU stay
Measured: 28 days
ventilator days
Measured: 28 days
iv fluids
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Apr 2022
- Primary completion1 Dec 2023
- Study completion10 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherouk Rafik, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592547
- Sponsor's protocol ID
- 0106979
- Status last verified
- Jan 2025
- First submitted
- 10 Sep 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT of INTRAVENOUS METOPROLOL TARTRATE on MORTALITY in PATIENTS with SEPTIC SHOCK DUE to VENTILATOR-ASSOCIATED PNEUMONIA Thesis
- ClinicalTrials.gov ID
- NCT06592547
- Acronym / sponsor ID
- 0106979
- Conditions
- Septic Shock, Ventilator Acquired Pneumonia
- Keywords
- Beta blockers, septic shock, Rate control, mortality
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 10 Nov 2024 (actual)
- First posted
- 19 Sep 2024 (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 RCT designed to assess the effect of giving intravenous beta-blockers in patients with septic shock after achieving hemodynamic stability. The principle of this study is to control heart rate allowing for better diastolic filling and thus better perfusion.
Detailed description
A RCT, conducted at alexandria main university hospital, patients were divided into 2 groups, Control group which received the standard care for septic shock and metoprolol group which recieved intravenous metoprolol then patients were assessed for Blood pressure, heart rate, iv fluids needed, vasopressor doses and 28 days mortality
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metoprolol group | Active comparator | Drug: Intravenous metoprolol tartrateThe group that received intravenous metoprolol |
| Control group | Placebo comparator | Other: Standard Care (in control arm)The group that received standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study population included adult patients (≥ 18 years) diagnosed with septic shock secondary to VAP with sinus tachycardia, from April 1, 2022, to April 31, 2023. Septic shock was defined according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). VAP was identified as per the guidelines provided by the American Thoracic Society and Infectious Diseases Society of America.
Key exclusion criteria (1 listed)
- Patients were excluded if they had contraindications to beta-blockers, had a history of heart failure, or had been receiving beta-blockers prior to the septic shock. Patients were also excluded if they developed complications from beta- blockers administration.
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 |
|---|---|---|
| Intravenous metoprolol tartrateAn intravenous beta-blockers, recieved FDA approval | Drug | Metoprolol group |
| Standard Care (in control arm)Standard care according to surviving sepsis campaign | Other | Control group |
Primary outcome
28-day Mortality
Time frame: 28 days
3 secondary outcomes
ICU stay
Time frame: 28 days
ventilator days
Time frame: 28 days
iv fluids
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intravenous metoprolol tartrate in people with Septic Shock and Ventilator Acquired Pneumonia, run by Alexandria 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 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: finished, as of the sponsor's last update on 29 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day Mortality (time frame: 28 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 29 Jan 2025.