Septic ShockPhase 2NCT05778838
Midodrine Effect on the Mortality Rates in Septic Shock Patients
A Phase 2 study testing Midodrine Oral Tablet in people with Septic Shock, run by Noha Mansour at 1 site in Egypt.
Trial summary
Assessing the safety and efficacy of the adjunctive use of midodrine as a vasopressor in septic shock patients by measuring the difference in the mortality rates between control and intervention groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Midodrine Oral Tablet
- Type of treatment
- Pill or oral medicine, 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
- 7 Nov 2022to 24 Jan 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
- Adult aged 18 years or older diagnosed with septic shock.
- Hypotensive and require IV vasopressor for more than 24 hours.
Who cannot join
- Hypovolemic shock.
- Severe organic heart disease (ejection fraction <30 percent).
- Bradycardia (HR<50 b/m).
- Chronic kidney disease (serum creatinine >2mg/dl).
- Thyrotoxicosis.
- Pheochromocytoma.
- Known allergy to midodrine.
- Unable to administer an oral medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study Evaluating the Efficacy and Safety of Adjunctive Use of Midodrine in Septic Shock Patients
Assessing the safety and efficacy of the adjunctive use of midodrine as a vasopressor in septic shock patients by measuring the difference in the mortality rates between control and intervention groups.
- Conditions
- Septic Shock
- Being tested
- Midodrine Oral Tablet
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midodrine Oral TabletDrug
Patients will receive standard treatment in accordance to surviving sepsis campaign guidelines plus oral midodrine 10 mg/ 8 hours till the end of treatment (subject remaining vasopressor-free for 24 consecutive hours) or death.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Will receive IV vasopressor infusion only Receives: Drug: Midodrine Oral Tablet |
| Midodrine | Active comparator | Will receive oral midodrine 10 mg/ 8 hours in addition to IV vasopressor infusion till the end of treatment (subject remaining vasopressor-free for 24 consecutive hours). Receives: Drug: Midodrine Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rates
The primary outcome is measuring the difference in ICU mortality rates between control and intervention group.
Measured: Time Frame: Starting from date of randomization till shock reversal or date of death from any cause, whichever came first,assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start7 Nov 2022
- Primary completion22 Dec 2023
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noha Mansour
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Noha Mansour, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778838
- Sponsor's protocol ID
- 2022-211
- Status last verified
- Feb 2025
- First submitted
- 10 Mar 2023
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El-Nagdy NK, Mansour NO, Diab AAA, Soliman MM. Efficacy of adjuvant use of midodrine in patients with septic shock: An open label randomized controlled trial. Pharmacotherapy. 2025 May;45(5):264-272. doi: 10.1002/phar.70018. Epub 2025 Apr 16.
PubMed 40241385
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Efficacy and Safety of Adjunctive Use of Midodrine in Septic Shock Patients
- ClinicalTrials.gov ID
- NCT05778838
- Acronym / sponsor ID
- 2022-211
- Conditions
- Septic Shock
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Noha MansourUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 21 Mar 2023 (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.
Assessing the safety and efficacy of the adjunctive use of midodrine as a vasopressor in septic shock patients by measuring the difference in the mortality rates between control and intervention groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Midodrine Oral TabletWill receive IV vasopressor infusion only |
| Midodrine | Active comparator | Drug: Midodrine Oral TabletWill receive oral midodrine 10 mg/ 8 hours in addition to IV vasopressor infusion till the end of treatment (subject remaining vasopressor-free for 24 consecutive hours). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult aged 18 years or older diagnosed with septic shock.
- Hypotensive and require IV vasopressor for more than 24 hours.
Key exclusion criteria (8 listed)
- Hypovolemic shock.
- Severe organic heart disease (ejection fraction <30 percent).
- Bradycardia (HR<50 b/m).
- Chronic kidney disease (serum creatinine >2mg/dl).
- Thyrotoxicosis.
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 |
|---|---|---|
| Midodrine Oral TabletPatients will receive standard treatment in accordance to surviving sepsis campaign guidelines plus oral midodrine 10 mg/ 8 hours till the end of treatment (subject remaining vasopressor-free for 24 consecutive hours) or death. | Drug | Control, Midodrine |
Primary outcome
Mortality rates
Time frame: Time Frame: Starting from date of randomization till shock reversal or date of death from any cause, whichever came first,assessed up to 30 days
The primary outcome is measuring the difference in ICU mortality rates between control and intervention group.
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 3 Mar 2025.
- Derived from this study: PubMed 40241385El-Nagdy NK, Mansour NO, Diab AAA, Soliman MM. Efficacy of adjuvant use of midodrine in patients with septic shock: An open label randomized controlled trial. Pharmacotherapy. 2025 May;45(5):264-272. doi: 10.1002/phar.70018. Epub 2025 Apr 16.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
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Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
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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 Midodrine Oral Tablet in people with Septic Shock, run by Noha Mansour 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 2 inclusion and 8 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 3 Mar 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?
Mortality rates (time frame: Time Frame: Starting from date of randomization till shock reversal or date of death from any cause, whichever came first,assessed up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05778838, which also lists 1 linked publication.
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 3 Mar 2025.