Spinal ShockPhase 2NCT04586790
the Effect of Oral Vasopressors for Liberation From IV Vasopressors in Spinal Shock
A Phase 2 study testing Midodrine Oral Tablet, Minirin oral tablet and Nor-Adrenaline in people with Spinal Shock, run by Ahmed talaat ahmed aly at 1 site in Egypt.
Trial summary
the study is developed to evaluate the effect of use of oral vasopressors (midodrine versus minirin) on weaning ICU patients from IV vasopressors (noradrenaline) and compare between them for efficacy in shortage the duration of IV vasopressor and has low complications and side effects. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Shock
- What is being tested?
- Midodrine Oral Tablet, Minirin oral tablet and Nor-Adrenaline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2020to 28 Jan 2021
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age of 18 - 60 years.
- Patients of both genders.
- Patients diagnosed by spinal shock and they are in the recovery stage .
Who cannot join
- Patient refusal.
- Anuric or oliguric patients or patients with chronic kidney disease.
- Patients with allergy to medication included in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Talaat Ahmed
Asyut
Amal A Mohamed, 0102 175 9992, amalabdelnasser28@gmail.com
Ahmed T Ahmed, lecture, 01062716629, Ahmedtalaat_ahmed@yahoo.com
About this study
Official title: The Effect of Oral Midodrine Versus Oral Desmopressin Acetate Use for Liberation From IV Noradrenaline in Intensive Care Unit Patients Recovering From Spinal Shock .
the study is developed to evaluate the effect of use of oral vasopressors (midodrine versus minirin) on weaning ICU patients from IV vasopressors (noradrenaline) and compare between them for efficacy in shortage the duration of IV vasopressor and has low complications and side effects.
- Conditions
- Spinal Shock
- Being tested
- Midodrine Oral Tablet, Minirin oral tablet, Nor-Adrenaline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midodrine Oral TabletDrug
midodrine group will receive midodrine 10 mg PO q 8 hr with gradual weaning of IV nor-adrenaline after receiving 4 doses of oral midodrine .
Minirin oral tabletDrug
Minirin group will receive minirin 60 µg PO q 8 hr with gradual weaning of IV nor-adrenaline after receiving 4 doses of oral minirin .
Nor-AdrenalineDrug
control group will receive IV nor-adrenaline and is gradually weaning from it according to routine hospital care without adding oral midodrine or oral minirin .
| Study group | Role | What they receive |
|---|---|---|
| midodrine group | Experimental | midodrine group will receive midodrine 10 mg PO q8hr with gradual weaning of IV noradrenaline after receiving 4 doses of oral midodrine Receives: Drug: Midodrine Oral Tablet |
| minirin group | Experimental | the patients will receive minirin 60 µg PO q8hr with gradual weaning of IV noradrenaline after receiving 4 doses of oral minirin Receives: Drug: Minirin oral tablet |
| control group | Experimental | the patients will receive IV nor-adrenaline and are gradually weaning from it according to routine hospital care without adding oral midodrine or oral minirin . Receives: Drug: Nor-Adrenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
liberation the patient from IV vasopressors with maintaining hemodynamics.
Blood pressure will be assessed regularly every 15 minutes
Measured: 48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start15 Oct 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion28 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed talaat ahmed aly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed talaat ahmed aly, Assiut University
- Investigators
- Ahmed T Ahmed, lecture, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586790
- Sponsor's protocol ID
- oral vasopressors
- Status last verified
- Oct 2020
- First submitted
- 7 Oct 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Midodrine Versus Oral Desmopressin Acetate Use for Liberation From IV Noradrenaline in Intensive Care Unit Patients Recovering From Spinal Shock .
- ClinicalTrials.gov ID
- NCT04586790
- Acronym / sponsor ID
- oral vasopressors
- Conditions
- Spinal Shock
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ahmed talaat ahmed alyUniversity, hospital or other
- Study start
- 15 Oct 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 28 Jan 2021 (estimated)
- First posted
- 14 Oct 2020 (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.
the study is developed to evaluate the effect of use of oral vasopressors (midodrine versus minirin) on weaning ICU patients from IV vasopressors (noradrenaline) and compare between them for efficacy in shortage the duration of IV vasopressor and has low complications and side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| midodrine group | Experimental | Drug: Midodrine Oral Tabletmidodrine group will receive midodrine 10 mg PO q8hr with gradual weaning of IV noradrenaline after receiving 4 doses of oral midodrine |
| minirin group | Experimental | Drug: Minirin oral tabletthe patients will receive minirin 60 µg PO q8hr with gradual weaning of IV noradrenaline after receiving 4 doses of oral minirin |
| control group | Experimental | Drug: Nor-Adrenalinethe patients will receive IV nor-adrenaline and are gradually weaning from it according to routine hospital care without adding oral midodrine or oral minirin . |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age of 18 - 60 years.
- Patients of both genders.
- Patients diagnosed by spinal shock and they are in the recovery stage .
Key exclusion criteria (3 listed)
- Patient refusal.
- Anuric or oliguric patients or patients with chronic kidney disease.
- Patients with allergy to medication included in the study.
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 Tabletmidodrine group will receive midodrine 10 mg PO q 8 hr with gradual weaning of IV nor-adrenaline after receiving 4 doses of oral midodrine . | Drug | midodrine group |
| Minirin oral tabletMinirin group will receive minirin 60 µg PO q 8 hr with gradual weaning of IV nor-adrenaline after receiving 4 doses of oral minirin . | Drug | minirin group |
| Nor-Adrenalinecontrol group will receive IV nor-adrenaline and is gradually weaning from it according to routine hospital care without adding oral midodrine or oral minirin . | Drug | control group |
Primary outcome
liberation the patient from IV vasopressors with maintaining hemodynamics.
Time frame: 48 hrs
Blood pressure will be assessed regularly every 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- 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.
Ahmed T Ahmed, lecture principal investigator
Assiut University
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, Minirin oral tablet and Nor-Adrenaline in people with Spinal Shock, run by Ahmed talaat ahmed aly 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 3 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 14 Oct 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 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 Ahmed T Ahmed, lecture (01062716629, Ahmedtalaat_ahmed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
liberation the patient from IV vasopressors with maintaining hemodynamics. (time frame: 48 hrs). 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 14 Oct 2020.