Septic ShockPhase 4NCT03911817
Impact of Midodrine Administration on the Clinical Outcome of Septic Shock Patients
A Phase 4 study testing Midodrine in people with Septic Shock, run by Ain Shams University at 1 site in Egypt.
Trial summary
1. Assess the impact of midodrine administration on weaning of IV vasopressors 2. Assess the cost effectiveness of using midodrine in critically ill patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Midodrine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2017to 30 Jul 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18-80)years
- Hypotensive (systolic blood pressure<90mm Hg)and require IV vasopressor for more than 24 hours
- Require IV vasopressor at rate < 8mcg/min and unable to wean for >24 hours
Who cannot join
- Severe organic heart disease (ejection fraction <30 percent due to higher risk of arrythmia)
- Bradycardia (HR<50 b/m)due to higher likelihood of symptomatic bradycardia
- Chronic kidney disease (serum creatinine >2mg/dl) as midodrine and its active metabolites are almost completely execreated in urine
- Thyrotoxicosis
- Known allergy to midodrine
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Critical Care Medicine Department - Cairo University Hospitals
Cairo
About this study
- Assess the impact of midodrine administration on weaning of IV vasopressors
- Assess the cost effectiveness of using midodrine in critically ill patients
Read the detailed description
A prospective randomized controlled clinical trial on total 60 critically ill patients admitted to critical care medicine department with indication to IV vasopressor due to septic shock on admission or during intensive care unit stay and they are randomly assigned to either of 2 groups as follows
- Group 1(n=30):will receive IV vasopressor infusion only
- Group 2(n=30):will receive midodrine in addition to IV vasopressor infusion
- Conditions
- Septic Shock
- Being tested
- Midodrine
- Keywords
- Midodrine, Septic shock, Norepinephrine, Weaning
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidodrineDrug
The oral vasoactive drug (Midodrine) at a dose of 10-20 mg every 8 hours will be used in one arm .After the blood pressure goal is met for more than 24 hours without IV vasopressor ,midodrine will be discontinued prior to discharge
| Study group | Role | What they receive |
|---|---|---|
| IV vasopressor | No intervention | Will receive IV vasopressor infusion only |
| Midodrine | Active comparator | Will receive midodrine in addition to IV vasopressor infusion Receives: Drug: Midodrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of weaning of IV vasopressor in both groups
measure duration needed to completely stop IV vasopressor in both groups and the impact of adding midodrine on that duration
Measured: Starting from date of randomization till stop of IV vasopressor completely or date of death from any cause,whichever came first,assessed up to 30 days
Secondary outcomes (4)
ICU length of stay
total duration of patient stay in ICU
Measured: Starting from date of randomization until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days
Time to ICU discharge after IV vasopressor discontinuation
measure duration from IV vasopressor stop till ICU discharge or death
Measured: Starting from discontinuation of IV vasopressor until time to ICU discharge or date of death from any cause ,whichever came first,assessed up to 30 days
Time to ICU discharge after midodrine initiation
measure duration from midodrine start till ICU discharge or death
Measured: Starting from midodrine initiation until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days
Mortality
measure if patient die or discharge from the ICU
Measured: 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 posted11 Apr 2019
- Study start15 Nov 2017
- Primary completion30 Jun 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina hussein ahmed eladly, Ain Shams University
- Investigators
- Lamiaa ELwakeel, PhD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911817
- Sponsor's protocol ID
- 169
- Status last verified
- Jan 2020
- First submitted
- 9 Apr 2019
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anstey MH, Wibrow B, Thevathasan T, Roberts B, Chhangani K, Ng PY, Levine A, DiBiasio A, Sarge T, Eikermann M. Midodrine as adjunctive support for treatment of refractory hypotension in the intensive care unit: a multicenter, randomized, placebo controlled trial (the MIDAS trial). BMC Anesthesiol. 2017 Mar 21;17(1):47. doi: 10.1186/s12871-017-0339-x.
PubMed 28327122Whitson MR, Mo E, Nabi T, Healy L, Koenig S, Narasimhan M, Mayo PH. Feasibility, Utility, and Safety of Midodrine During Recovery Phase From Septic Shock. Chest. 2016 Jun;149(6):1380-3. doi: 10.1016/j.chest.2016.02.657. Epub 2016 Mar 4.
PubMed 26953217
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Midodrine Administration on the Clinical Outcome of Septic Shock Patients
- ClinicalTrials.gov ID
- NCT03911817
- Acronym / sponsor ID
- 169
- Conditions
- Septic Shock
- Keywords
- Midodrine, Septic shock, Norepinephrine, Weaning
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 11 Apr 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.
- Assess the impact of midodrine administration on weaning of IV vasopressors
- Assess the cost effectiveness of using midodrine in critically ill patients
Detailed description
A prospective randomized controlled clinical trial on total 60 critically ill patients admitted to critical care medicine department with indication to IV vasopressor due to septic shock on admission or during intensive care unit stay and they are randomly assigned to either of 2 groups as follows
- Group 1(n=30):will receive IV vasopressor infusion only
- Group 2(n=30):will receive midodrine in addition to IV vasopressor infusion
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| IV vasopressor | No intervention | –Will receive IV vasopressor infusion only |
| Midodrine | Active comparator | Drug: MidodrineWill receive midodrine in addition to IV vasopressor infusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (18-80)years
- Hypotensive (systolic blood pressure<90mm Hg)and require IV vasopressor for more than 24 hours
- Require IV vasopressor at rate < 8mcg/min and unable to wean for >24 hours
Key exclusion criteria (5 listed)
- Severe organic heart disease (ejection fraction <30 percent due to higher risk of arrythmia)
- Bradycardia (HR<50 b/m)due to higher likelihood of symptomatic bradycardia
- Chronic kidney disease (serum creatinine >2mg/dl) as midodrine and its active metabolites are almost completely execreated in urine
- Thyrotoxicosis
- Known allergy to midodrine
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 |
|---|---|---|
| MidodrineThe oral vasoactive drug (Midodrine) at a dose of 10-20 mg every 8 hours will be used in one arm .After the blood pressure goal is met for more than 24 hours without IV vasopressor ,midodrine will be discontinued prior to discharge | Drug | Midodrine |
Primary outcome
Time of weaning of IV vasopressor in both groups
Time frame: Starting from date of randomization till stop of IV vasopressor completely or date of death from any cause,whichever came first,assessed up to 30 days
measure duration needed to completely stop IV vasopressor in both groups and the impact of adding midodrine on that duration
4 secondary outcomes
ICU length of stay
Time frame: Starting from date of randomization until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days
Time to ICU discharge after IV vasopressor discontinuation
Time frame: Starting from discontinuation of IV vasopressor until time to ICU discharge or date of death from any cause ,whichever came first,assessed up to 30 days
Time to ICU discharge after midodrine initiation
Time frame: Starting from midodrine initiation until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days
Mortality
Time frame: Up to 30 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 9 Jan 2020.
- Background: PubMed 28327122Anstey MH, Wibrow B, Thevathasan T, Roberts B, Chhangani K, Ng PY, Levine A, DiBiasio A, Sarge T, Eikermann M. Midodrine as adjunctive support for treatment of refractory hypotension in the intensive care unit: a multicenter, randomized, placebo controlled trial (the MIDAS trial). BMC Anesthesiol. 2017 Mar 21;17(1):47. doi: 10.1186/s12871-017-0339-x.
- Background: PubMed 26953217Whitson MR, Mo E, Nabi T, Healy L, Koenig S, Narasimhan M, Mayo PH. Feasibility, Utility, and Safety of Midodrine During Recovery Phase From Septic Shock. Chest. 2016 Jun;149(6):1380-3. doi: 10.1016/j.chest.2016.02.657. Epub 2016 Mar 4.
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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Septic Shock
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.
Lamiaa ELwakeel, PhD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Midodrine in people with Septic 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 5 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 9 Jan 2020. 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. 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?
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?
Time of weaning of IV vasopressor in both groups (time frame: Starting from date of randomization till stop of IV vasopressor completely 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 NCT03911817, which also lists 2 linked publications.
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 9 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.