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 @ 10:49 PM
Ignite Modification Date:
2025-12-24 @ 10:49 PM
NCT ID:
NCT04901169
Eligibility Criteria:
Inclusion Criteria:
* Age \> or = 18 years
* Liver transplantation from a deceased donor
* Model for End-stage Liver Disease Sodium (MELD-Na) score \> or = 25 at the time of transplant (not counting MELD exception points)
* Patient requiring \> 0.05 mcg/kg/min of norepinephrine (NE) during LT
Exclusion Criteria:
* Living-donor liver transplantation (LDLT)
* Split liver transplantation (isolated right or left lobe)
* Donation after cardiac death (DCD) without normothermic machine perfusion (NMP)
* Acute liver failure (ALF)
* Listed for or receiving simultaneous liver-kidney transplantation (SLKT)
* Liver re-transplantation (patient who has previously received a liver transplant)
* Preoperative treatment with angiotensin II receptor blocker or angiotensin converting enzyme inhibitor (within 48 h)
* Portopulmonary hypertension
* Left ventricular systolic dysfunction (defined as ejection fraction \< 45%)
* Active bronchospasm at time of LT
* History of thrombotic or embolic disease, inherited hypercoagulable disorder, or therapeutic anticoagulation
* Portal vein thrombosis
* Celiac stenosis
* End-stage renal disease (chronic eGFR \< 15 mL/min/1.73 m2 or chronic RRT - not including AKI requiring RRT)
* History of Raynaud's disease
* Known history of allergy to synthetic human angiotensin II
* Subject intubated and/or mechanically ventilated prior to entering OR for LT
* Presence of other condition or abnormality that would compromise the safety of the patient or quality of the data
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04901169
Study Brief:
Protocol Section:
NCT04901169