PUBLICADO EM 12/11/2017

Metodos Trial: duplo cego, placebo e controlado (comparativo) : Fevereiro 2013 – Março de 2017. Pacientes submetidos a angiografia coronária ou não com RFGe de 15 a 44.9 ml/ min/ 1.73 m2 e 45 to 59.9 ml/ min/ 1.73 m2 (diabéticos) Excluídos pacientes submetidos a angiografia de urgência ou niveis instaveis de creatinina 4993 PACIENTES INCLUÍDOS From February 2013 through March 2017, patients were enrolled at 53 medical centers in the United States (35 Veterans Affairs sites), Australia (13 sites), Malaysia (3 sites), and New Zealand (2 sites0 We excluded patients who were undergoing emergency angiography and those with unstable baseline levels of blood creatinine (which was defined as an increase or decrease of ≥25% within 3 days before angiography)

We restricted our study population to patients with stage 3 or 4 chronic kidney disease (eGFR of 30 to 59.9 ml per minute per 1.73 m2 for stage 3 and 15 to 29.9 ml per minute per 1.73 m2 for stage 4); those with stage 3A (eGFR of 45 to 59.9 ml per minute per 1.73 m2) were required to have diabetes mellitus, a condition that increases the risk of contrast-associated acute kidney injury in patients with impaired kidney function.25

METODOS Cr: baseline, 3 a 5 dias e 90 a 104 dias após o exame Bic de Sódio IV 1.26% (150 mmo/L) NaCl IV 0.9% (154 mmol/L) NAC oral/placebo 1200mg 1h antes e após angiografia 2 x dia nos próximos 4 dias 1 a 3 ml/ kg/h 1 – 12h (volume total de 3 a 12 ml/kg ) antes 1 a 1.5 ml/Kg /h durante a angiografia 1 to 3 ml/Kg/h 2 a 12h (volume total de 6 a 12 ml/Kg) após a angiografia Cr: baseline, 3 a 5 dias e 90 a 104 dias após o exame Urina : Alb/Cr e pH urinário. 2 a 24h h após exame We administered 1200 mg of oral acetylcysteine or matched placebo approximately 1 hour before angiography and again 1 hour after angiography. Patients were instructed to continue to take 1200 mg of acetylcysteine or matched placebo twice daily for the following 4 days for a total of 10 doses.

DESFECHOS PRIMÁRIO ÓBITO NECESSIDADE DE DIÁLISE AUMENTO PERSISTENTE DA Cr (de ao menos 50% em relação a basal em 90 dias). SECUNDÁRIO IRA

DESFECHOS PRIMÁRIOS 110 pacientes (4.4%) Bic de Sódio vs. 116 (4.7%) NaCl (odds ratio, 0.93; 95% confidence interval [CI], 0.72 to 1.22; P = 0.62), 114 patients (4.6%) no grupo de NAC vs. 12 (4.5%) no placebo (odds ratio, 1.02; 95% CI, 0.78 to 1.33; P = 0.88) The primary composite end point occurred in 110 patients (4.4%) in the sodium bicarbonate group as compared with 116 patients (4.7%) in the sodium chloride group (odds ratio, 0.93; 95% confidence interval [CI], 0.72 to 1.22; P = 0.62), and in 114 patients (4.6%) in the acetylcysteine group as compared with 112 (4.5%) in the placebo group (odds ratio, 1.02; 95% CI, 0.78 to 1.33; P = 0.88) There were no significant differences in the primary composite end point in the comparison of treatment combination groups (Table S8 in the Supplementary Appendix)

DESFECHOS SECUNDÁRIOS

Conclusão do Estudo PRESERVE “ Em pacientes, com alto risco de complicações renais, que foram submetidos a angiografia, não houve beneficio do uso endovenoso de bicarbonato de sódio sobre o cloreto de sódio ou da NAC sobre o placebo, em relação: a necessidade de diálise, óbito, persistente declinio da função renal no periodo de 90 dias ou na prevenção da IRA relacionada ao uso de contraste” (Financiado : U.S. Department of Veterans Affairs Office of Research and Development and the National Health and Medical Research Council of Australia; PRESERVE ClinicalTrials.gov number, NCT01467466.)

LIMITAÇÕES PERIODO DE 90 DIAS DOSAGEM ÚNICA DE CREATININA PACIENTES COM MENOS COMORBIDADES (CR BASAL média DE 1,5MG/dL) HOMENS SOMENTE INVESTIGADOS PEQUENO VOLUME DE CONTRASTE SEM INTERVENÇÃO Our trial has certain limitations. First, the use of a primary end point that was assessed at 90 days created the possibility that any benefit of the interventions might have been masked by intervening events (e.g., coronary-artery bypass surgery). However, this possibility was markedly diminished by the absence of benefit with respect to contrast-associated acute kidney injury for either study intervention. Second, to assess contrast-associated acute kidney injury, we measured serum creatinine at a single time point after angiography

LEMBRAR DOS FATORES DE RISCO Desidratação Estado hemodinâmico alterado Idade >70 anos Uso concomitante de droga nefrotóxica Altas e multiplas doses de contraste VISCOSIDADE -RFGe <45 ml/min/1.73 m2 ou <60 ml/min/1.73 m2) -IRA ou DRC prévia -ND -ANEMIA Michael Fähling, Erdmann Seeliger, Andreas Patzak , Pontus B. Persson NATURE REVIEWS | NEPHROLOGY VOLUME 13 | MARCH 2017

COMENTÁRIOS PACIENTES INTERNADOS VS. AMBULATORIAIS (PROFILAXIA DEVE LEVAR EM CONSIDERAÇÃO O VOLUME DE CONTRASTE E FATORES DE RISCO). -Procedimentos de emergência e intervenções coronarianas complexas que necessitem de altas doses de contraste-MANTER -Risco menor em pacientes com FR estável ou discretamente alterada. A reidratação oral parece ser uma boa alternativa FATORES PREDITORES VOLUME DE CONTRASTE(TIPO DE PROCEDIMENTO)