Renal Insufficiency Following Contrast Media Administration Trial (REMEDIAL): a randomized comparison of 3 preventive strategies.
BACKGROUND
Volume supplementation by saline infusion combined with N-acetylcysteine (NAC) represents an effective strategy to prevent contrast agent-induced nephrotoxicity (CIN). Preliminary data support the concept that sodium bicarbonate and ascorbic acid also may be effective in preventing CIN.


RESULTS
Three hundred twenty-six consecutive patients with chronic kidney disease, referred to our institutions for coronary and/or peripheral procedures, were randomly assigned to prophylactic administration of 0.9% saline infusion plus NAC (n=111), sodium bicarbonate infusion plus NAC (n=108), and 0.9% saline plus ascorbic acid plus NAC (n=107). All enrolled patients had serum creatinine > or = 2.0 mg/dL and/or estimated glomerular filtration rate < 40 mL x min(-1) x 1.73 m(-2). Contrast nephropathy risk score was calculated in each patient. In all cases, iodixanol (an iso-osmolar, nonionic contrast agent) was administered. The primary end point was an increase of > or = 25% in the creatinine concentration 48 hours after the procedure (CIN). The amount of contrast media administered (179+/-102, 169+/-92, and 169+/-94 mL, respectively; P=0.69) and risk scores (9.1+/-3.4, 9.5+/-3.6, and 9.3+/-3.6; P=0.21) were similar in the 3 groups. CIN occurred in 11 of 111 patients (9.9%) in the saline plus NAC group, in 2 of 108 (1.9%) in the bicarbonate plus NAC group (P=0.019 by Fisher exact test versus saline plus NAC group), and in 11 of 107 (10.3%) in the saline plus ascorbic acid plus NAC group (P=1.00 versus saline plus NAC group).


CONCLUSIONS
The strategy of volume supplementation by sodium bicarbonate plus NAC seems to be superior to the combination of normal saline with NAC alone or with the addition of ascorbic acid in preventing CIN in patients at medium to high risk.
Briguori
Carlo
C
Laboratory of Interventional Cardiology, Clinica Mediterranea, Via Orazio, 2, I-80121, Naples, Italy. briguori.carlo@hsr.it
Airoldi
Flavio
F
D'Andrea
Davide
D
Bonizzoni
Erminio
E
Morici
Nuccia
N
Focaccio
Amelia
A
Michev
Iassen
I
Montorfano
Matteo
M
Carlino
Mauro
M
Cosgrave
John
J
Ricciardelli
Bruno
B
Colombo
Antonio
A
D000111:Acetylcysteine / Q000627:therapeutic use*; D000284:Administration, Oral; D000368:Aged; D001205:Ascorbic Acid / Q000008:administration & dosage; D002318:Cardiovascular Diseases / Q000150:complications / Q000175:diagnosis; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects*; D003404:Creatinine / Q000097:blood; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006801:Humans; D007262:Infusions, Intravenous; D007674:Kidney Diseases / Q000150:complications / Q000503:physiopathology*; D008297:Male; D051437:Renal Insufficiency / Q000097:blood / Q000139:chemically induced* / Q000517:prevention & control*; D012307:Risk Factors; D017693:Sodium Bicarbonate / Q000008:administration & dosage; D012965:Sodium Chloride / Q000008:administration & dosage; D016896:Treatment Outcome; D014283:Triiodobenzoic Acids / Q000008:administration & dosage / Q000009:adverse effects*
D003287:Contrast Media; D014283:Triiodobenzoic Acids; D012965:Sodium Chloride; D017693:Sodium Bicarbonate; D003404:Creatinine; C044834:iodixanol; D001205:Ascorbic Acid; D000111:Acetylcysteine