title: Systemic hypothermia to prevent radiocontrast nephropathy (from the COOL-RCN Randomized Trial).
abstract: Radiocontrast nephropathy (RCN) develops in a substantial proportion of patients with chronic kidney disease (CKD) after invasive cardiology procedures and is strongly associated with subsequent mortality and adverse outcomes. We sought to determine whether systemic hypothermia is effective in preventing RCN in patients with CKD. Patients at risk for RCN (baseline estimated creatinine clearance 20 to 50 ml/min) undergoing cardiac catheterization with iodinated contrast ≥50 ml were randomized 1:1 to hydration (control arm) versus hydration plus establishment of systemic hypothermia (33°C to 34°C) before first contrast injection and for 3 hours after the procedure. Serum creatinine levels at baseline, 24 hours, 48 hours, and 72 to 96 hours were measured at a central core laboratory. The primary efficacy end point was development of RCN, defined as an increase in serum creatinine by ≥25% from baseline. The primary safety end point was 30-day composite rate of adverse events consisting of death, myocardial infarction, dialysis, ventricular fibrillation, venous complication requiring surgery, major bleeding requiring transfusion ≥2 U, or rehospitalization. In total 128 evaluable patients (mean creatinine clearance 36.6 ml/min) were prospectively randomized at 25 medical centers. RCN developed in 18.6% of normothermic patients and in 22.4% of hypothermic patients (odds ratio 1.27, 95% confidence interval 0.53 to 3.00, p = 0.59). The primary 30-day safety end point occurred in 37.1% versus 37.9% of normothermic and hypothermic patients, respectively (odds ratio 0.97, 95% confidence interval 0.47 to 1.98, p = 0.93). In conclusion, in patients with CKD undergoing invasive cardiology procedures, systemic hypothermia is safe but is unlikely to prevent RCN.
authors.affiliation: Columbia University Medical Center/New York-Presbyterian Hospital, Cardiovascular Research Foundation, New York, USA. gs2184@columbia.edu
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Kishor
authors.initials: K
authors.lastname: Vora
authors.forename: John
authors.initials: J
authors.lastname: Schindler
authors.forename: Claro
authors.initials: C
authors.lastname: Diaz
authors.forename: Tift
authors.initials: T
authors.lastname: Mann
authors.forename: George
authors.initials: G
authors.lastname: Dangas
authors.forename: Patricia
authors.initials: P
authors.lastname: Best
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
mesh_terms: D000368:Aged; D006328:Cardiac Catheterization; D003287:Contrast Media / Q000009:adverse effects*; D003404:Creatinine / Q000097:blood; D005260:Female; D006801:Humans; D007036:Hypothermia, Induced; D007674:Kidney Diseases / Q000175:diagnosis* / Q000517:prevention & control*; D007676:Kidney Failure, Chronic / Q000150:complications*; D008297:Male; D016896:Treatment Outcome
chemical_list: D003287:Contrast Media; D003404:Creatinine