Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-24 @ 2:47 PM
NCT ID:
NCT04668859
Eligibility Criteria:
Inclusion Criteria:
* post-cardiopulmonary bypass surgery
* vasoplegic syndrome criteria
1. MAP \< 65mmHg
2. Cardiac index\>/=2.4 L/min/m\^2, as determined by Swan-
3. systemic vascular resistance index \</=1400 dynes s/cm\^5/m\^2
4. adequate fluid resuscitation as determined by treating critical care team
* vasopressor requirement
1. norepinephrine 0.05-0.5 mcg/kg/min WITH/WITHOUT
2. vasopressin any dose
Exclusion Criteria:
* allergy to midodrine
* pregnancy
* midodrine or cardiac glycoside as preadmission medication
* history of orthostatic hypotension, thyrotoxicosis, or pheochromocytoma
* severe organic heart disease (endocarditis, untreated congenital or rheumatic heart disease)
* liver failure/cirrhosis
* chronic kidney disease (GFR \<30mL/hr)
* ventricular assist device implantation procedure, intra-aortic balloon pump placement, or heart transplantion
* unresolved post-operative acute kidney injury (rise in serum creatinine by \>/= 0.5mg/dl from baseline
* inadequate tissue oxygenation (lactate \> 2 mmol/L)
* inability to take oral medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04668859
Study Brief:
Protocol Section:
NCT04668859