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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Will receive IV vasopressor infusion only |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midodrine Oral Tablet | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rates | The primary outcome is measuring the difference in ICU mortality rates between control and intervention group. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University | Al Mansurah | 35516 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40241385 | Derived | 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. |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D008879 | Midodrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D000588 |
| Amines |