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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV vasopressor | No Intervention | Will receive IV vasopressor infusion only | |
| Midodrine | Active Comparator | Will receive midodrine in addition to IV vasopressor infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midodrine | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Description | Time Frame |
|---|---|---|
| ICU length of stay | total duration of patient stay in ICU | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lamiaa ELwakeel, PhD | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Critical Care Medicine Department - Cairo University Hospitals | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28327122 | Background | 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. | |
| 26953217 |
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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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Prospective randomized controlled clinical trial
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measure duration from IV vasopressor stop till ICU discharge or death
| 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 | 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 | Up to 30 days |
| Whitson 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. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D000588 |
| Amines |