Aspect | Definition |
---|---|
Target population | Patients ≥ 50 years old who undergo emergency bowel surgery |
Endpoint | Days alive and out of hospital within 90 days of randomisation (DAOH-90 = count of days alive and out of hospital within 90 days of randomisation where DAOH-90 = 0 if patient dies within 90 days and DAOH-90 = 90 − (days in hospital within 90 days of randomisation) if patient alive 90 days after randomisation) |
Treatment conditions | Intervention group—Protocolised cardiac output-guided haemodynamic therapy during surgery, and for 6 h after, regardless of whether the haemodynamic protocol has been followed correctly Usual care group—Intravenous fluid administration without the use of cardiac output monitoring or protocol |
Summary measure | Ratio of means (Intervention vs. usual care group) |
Intercurrent events | Strategy |
Surgery not received (applies to both treatment arms) | Principal stratum (of participants who would undergo surgery regardless of treatment allocation) |
Procedure modified after surgery begins such that no longer eligible for NELA (applies to both treatment arms) | Treatment policy |
Receipt of cardiac output monitoring (control arm only) | Treatment policy |
Failure to initiate cardiac output monitoring during/after surgery (intervention arm only) | Treatment policy |
Cardiac output monitoring initiated but intervention algorithm not followed | Treatment policy |