Table 2.
Key data collection points and procedures
| Preoperation | Operation day | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Discharge | 6 weeks | 3 months | |
| Eligibility | ✓ | |||||||||
| Written consent | ✓ | |||||||||
| Concomitant medication concomitant medication only in relation to infection apart from pre op | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Pregnancy testing | ✓ | |||||||||
| Randomisation | ✓ | |||||||||
| Operative details | ✓* | |||||||||
| MODSs | ✓ | (6–12 hours) | ✓ (24 hours) |
✓ (48 hours) |
✓ (72 hours) |
✓ (96 hours) |
||||
| Clinical outcomes | ✓ | ✓ | ✓ | ✓ | ✓ | ✓† | ✓‡ | |||
| Serious adverse event monitoring/adverse events | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓† | ✓ | |
| Bloods: serum biochemistry (creatinine, amylase, liver function tests) and full blood counts | ✓ | ✓ (CICU* and 6–12 hours) |
✓* | ✓* | ✓* | ✓* | ✓*§ | ✓§* | ✓ | |
| Organ injury markers; urine NGAL, serum troponin | Urine ✓ Troponin I | ✓ Troponin I (6–12 hours) | Urine ✓ | ✓ Troponin I (48 hours) | ||||||
| RH-PAT testing | ✓ | ✓ | ||||||||
| Bloods: citrated whole blood for flow cytometry | ✓ | ✓ (6–12 hours) | ✓ | |||||||
| Tracheal aspirate | ✓ (4–6 hours) | |||||||||
| Questionnaire | ✓ | ✓ |
*Indicates samples taken usually as part of normal care.
†4–6 week time point in accordance with normal postoperative care.
‡Indicates data collection via postal questionnaires.
§Final time point if patient is discharged.
CICU, cardiac intensive care unit; MODS, Multiple Organ Dysfunction Score; NGAL, Neutrophil Gelatinase Associated Lipocalin; RH-PAT, reactive hyperaemia peripheral arterial tonometry.