Table 1.
Day number in relation to surgery day | −1 | 0 | 1 | 2 | 3 | 4 | 1 month telephone call |
---|---|---|---|---|---|---|---|
Informed consent | X | ||||||
Inclusion/exclusion criteria | X | X | |||||
Randomisation | X | ||||||
Study drug | X | ||||||
AE and SAE registration and report | X | X | X | X | X | X | |
Blood ciclosporin concentration | X | X | |||||
Blood tests efficacy: P-cystatin C, P-creatinine | X | X | X | X | X | ||
Analysis U-TIMP-2, U-IGFBP7, U-albumin/creatinine | X | X | |||||
Blood tests safety: Mg, K, urea, myoglobin, ASAT, ALAT, bilirubin, ALP, GT, leucocytes, CRP, CK, Hb, Trc | X | X | X | X | X | ||
Exploratory immunological tests | X | X | |||||
Blood tests cardiac: troponin T, CK MB | X | X | X | X | X | ||
Blood test cerebral: S-S100B | X | X | X | ||||
Documentation of: hourly diuresis, bleeding at 12 hours and total, time to extubation, time in ICU, fluid balance | X | X | |||||
Temperature, blood pressure | X | X | X | X | X | ||
Scoring leg wound infection. | X |
Day −1 illustrates the day before surgery, usually the same as admission day, day 0 surgery day, day 1 the day after surgery, etc.
AE, adverse event; ALAT, alanine aminotransferase; ALP, alkaline phosphatase; ASAT, aspartate aminotransferase; CK, creatine kinase; CRP, C reactive protein; GT, γ-glutamyl transferase; Hb, haemoglobin; ICU, intensive care unit; IGFBP7, insulin-like growth factor binding protein 7; K, potassium; Mg, magnesium; SAE, serious adverse event; TIMP-2, tissue inhibitor of metalloproteinase 2; Trc, thrombocytes.