Table 1 Definition and assessment of key secondary endpoints
Secondary endpoint | Definition | Assessment |
|---|---|---|
Pneumonia | Presence of new infiltrate on chest x-ray OR CT scan | Yes/no (severity according to Clavien-Dindo classification) |
Mortality | Death before POD 30 during hospital stay as well as after discharge | Yes/no, cause of death, and date of death |
Hospital stay | Days from day of initial operation to day of hospital discharge | Days of inpatient treatment |
Fluids given intraoperatively | Amount of fluids given intraoperatively | Crystalloid fluids in milliliters Colloidal fluids in milliliters |
Vasopressor therapy intraoperatively | Amount of vasopressor during operation | Type of vasopressor, amount in milligrams |
Fluids given postoperatively | Amount of fluids given postoperatively until POD 4 or death | Crystalloid fluids in milliliters, colloidal fluids in milliliters |
Vasopressor therapy postoperatively | Amount of vasopressor after operation until POD 4 or death | Type of vasopressor, amount in milligrams |
Weight over time/weight changes | Patient’s weight on day of screening, POD 2, and POD 4 | Weight in kilograms |
Re-operation | Reoperation up to POD 30 or death | Date and cause of every reoperation |
Postoperative pain | Pain level on POD 2 and 4 during movement and at rest (NRS) | NRS |