Prevention of contrast induced nephropathy with sodium bicarbonate (the PROMEC study)

Abstract

Prevention of contrast induced nephropathy with sodium bicarbonate (the PROMEC study)Prevenção de nefropatia por contraste com bicarbonato de sódio (o estudo PROMEC)

Bicarbonato de sodio versus solución salina isotónica para la prevención de la nefropatía inducida por medio de contraste: Revisión sistemática y meta-análisis

“…Among the studies that included SB administration, 18 administered SB diluted with 5% dextrose in distilled water (D5%DW), and 4 did not specify the dilution of bicarbonate used 16 - 19 ; however, stabilized bicarbonate is only achieved with the addition of dextrose, so it can be assumed that this dilution was performed. The quantity of D5%DW for dilution differed among the studies; in 16 studies, 154 mL of bicarbonate (1,000 mEq/L) was diluted in 846 mL of D5%DW (studies 8 , 15 , 20 - 32 , 33 ); in the remaining studies, different mixtures of bicarbonate and D5%DW were used; the infusion speed was 1 to 3 mL/k/h within 1 to 12 h before the radiological procedure was performed and then between 6 and 12 h post-procedure ( Table 1 ). In six studies 20 , 21 , 23 , 27 , 29 , 32 , NAC was used along with the sodium bicarbonate.…”

“…The primary outcome evaluated in 13 studies was the presence of CIN, defined as a 25% elevation in serum creatinine above the baseline or a 0.5-mg/dL increase during the first 48 hours after the contrast medium was administered 8 , 15 , 16 , 17 , 19 - 22 , 27 , 29 - 32 ; in seven studies, the same definition was used, but CIN was diagnosed up to 5 days post-contrast medium administration 23 , 25 , 26 , 28 , 33 - 35 ; the other two studies used the maximum increase in serum creatinine as an outcome measure 18 , 24 .…”

“…The need for RRT was evaluated in 15 studies and was defined across the board as the need for hemodialysis 48-72 h after exposure to contrast media secondary to acute renal failure 18 - 23 , 28 , 30 - 34 ; in one study, the need for hemodialysis up to 30 days after contrast medium exposure was considered 27 . In 15 studies, mortality was defined as death by any cause within 28 days post procedure 15 , 16 - 19 , 21 - 23 , 26 - 29 , 31 , 32 , 34 . The difference in creatinine was assessed in 8 studies, which reported the mean differences in the creatinine level before and after exposure to contrast media in both groups.…”

“…While randomization was effectively reported in 6 studies (27.3%), they failed to specify how they were conducted 17 , 18 , 21 , 28 , 32 , 35 ; in other studies, randomization was deemed adequate. In relation to the concealment of the random sequence, it was deemed adequate in 8 studies (36%) 15 , 18 , 22 - 24 , 28 , 31 , 34 ; in 11(50.0%) it was deemed uncertain given that the type of concealment was not defined and three (13.7%) of the concealments were equally not conducted 8 , 29 , 30 .…”

“…Contrast-induced nephropathy is defined as a glomerular filtration rate (GFR) decrease greater than 25% calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula or as an increase in serum creatinine greater than 0.5 mg/dL compared to the baseline within 48 h of the procedure or an absolute increase of 25% compared to the baseline 4 , 15 . Additionally, some secondary outcomes were evaluated, including the need for renal replacement therapy (RRT), the exchange difference with basal serum creatinine, and mortality.…”