Clinical Trial Outcomes

Preliminary benefit outcomes include body composition, circumferences, diet quality, alcohol and smoking, and physical activity. Successful liberation is defined as disconnection from mechanical ventilation without re-intubation in the next seven days, or until ICU or live hospital discharge. A successful therapeutic outcome requires limited PPI intake and willingness to continue the current treatment strategy. Secondary failures and drop-outs are counted as unsuccessful outcomes. Primary-outcome MACE includes death, heart failure, cardiac arrest, acute myocardial infarction, cardiogenic shock, malignant arrhythmia, acute kidney injury, and acute stroke. Patients must meet both positive indicators at every 3-month follow-up assessment to count as successful. Taking PPI more than 2 to 3 times per month is treated as active PPI use and failure. The primary trial outcome is HAPI incidence across the three study groups. The hierarchical co-primary endpoints are complete biochemical cure and complete clinical cure at 6 months after intervention. Complete clinical cure is normotension without antihypertensive medication. Secondary outcomes include pressure injury stage, patient particip…