Primary, secondary and safety outcomes
| Outcome | Study group; no. (%) of patients* | p value | |
|---|---|---|---|
| Curcumin n = 304 | Placebo n = 302 | ||
| Primary† | |||
| Postoperative urine IL-18, pg/mL, median (IQR) | 13 (6 to 27) | 16 (7 to 30) | 0.2 |
| Perioperative rise (postoperative minus preoperative) | |||
| Serum creatinine, μmol/L, median (IQR) | 1 (−7 to 19) | 1 (−6 to 12) | 0.2 |
| Plasma NT-pro-BNP, mesoscale pg/mL, median (IQR) | 221 (67 to 511) | 184 (48 to 431) | 0.1 |
| Plasma high-sensitivity C-reactive protein, μg/mL, median (IQR) | 58 (28 to 95) | 58 (30 to 90) | 0.9 |
| Secondary‡ | |||
| Acute kidney injury | 51 (17) | 30 (10) | 0.01 |
| Hospital length of stay, d, median (IQR) | 5 (2 to 8) | 5 (2 to 7) | > 0.9 |
| Composite of clinical events | 28 (9) | 27 (9) | 0.9 |
| Outcomes to assess curcumin safety‡ | |||
| Change in hemoglobin (postoperative minus preoperative), g/L, median (IQR) | −33 (−46 to −23) | −32 (−43 to −24) | 0.6 |
| Clinically important bleeding | 7 (2) | 10 (3) | 0.4 |
| Peptic ulcer | 2 (1) | 1 (< 1) | 0.6 |
| Glucose 0–3 h after repair, mmol/L, median (IQR) | 7 (6 to 9) | 7 (6 to 9) | 0.3 |
| Hypoglycemic event | 9 (3) | 3 (1) | 0.1 |
| Diarrhea | 16 (5) | 20 (7) | 0.5 |
| Any nausea | 31 (10) | 25 (8) | 0.4 |
Note: IL-18 = interleukin-18, IQR = interquartile range, NT-pro-BNP = N-terminal pro–B-type natriuretic peptide.
↵* Except where indicated otherwise.
↵† Preoperative and postoperative values for serum creatinine, plasma NT-pro-BNP and plasma high-sensitivity C-reactive protein are presented in the table in section 10 of Appendix 1 (available at www.cmaj.ca/lookup/suppl/doi:10.1503/cmaj.180510/-/DC1). See Methods section for a description of the measurement schedule.
↵‡ Outcomes are defined in section 5 of Appendix 1 (available at www.cmaj.ca/lookup/suppl/doi:10.1503/cmaj.180510/-/DC1).