Stephen J Traub1, Alice M Mitchell2, Alan E Jones3, Aimee Tang4, Jennifer O'Connor4, Teresa Nelson5, John Kellum4, Nathan I Shapiro6. 1. Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Department of Emergency Medicine, Mayo Clinic Arizona, Phoenix, AZ; Mayo Clinic College of Medicine, Rochester, MN; Department of Emergency Medicine, Mayo Clinic Arizona, Phoenix, AZ. Electronic address: traub.stephen@mayo.edu. 2. Indiana University School of Medicine, Indianapolis, IN. 3. University of Mississippi Medical Center, Jackson, MS. 4. Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA. 5. Center for Vascular Biology, Beth Israel Deaconess Medical Center, Boston, MA. 6. Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Technomics Research, Minneapolis, Minnesota; Department of Critical Care, University of Pittsburgh School of Medicine, Pittsburgh, PA; Harvard Medical School, Boston, MA.
Abstract
STUDY OBJECTIVE: We test the hypothesis that N-acetylcysteine plus normal saline solution is more effective than normal saline solution alone in the prevention of contrast-induced nephropathy. METHODS: The design was a randomized, double blind, 2-center, placebo-controlled interventional trial. Inclusion criteria were patients undergoing chest, abdominal, or pelvic computed tomography (CT) scan with intravenous contrast, older than 18 years, and at least one contrast-induced nephropathy risk factor. Exclusion criteria were end-stage renal disease, pregnancy, N-acetylcysteine allergy, or clinical instability. Intervention for the treatment group was N-acetylcysteine 3 g in 500 mL normal saline solution as an intravenous bolus and then 200 mg/hour (67 mL/hour) for up to 24 hours; and for the placebo group was 500 mL normal saline solution and then 67 mL/hour for up to 24 hours. The primary outcome was contrast-induced nephropathy, defined as an increase in creatinine level of 25% or 0.5 mg/dL, measured 48 to 72 hours after CT. RESULTS: The data safety and monitoring board terminated the study early for futility. Of 399 patients enrolled, 357 (89%) completed follow-up and were included. The N-acetylcysteine plus saline solution group contrast-induced nephropathy rate was 14 of 185 (7.6%) versus 12 of 172 (7.0%) in the normal saline solution only group (absolute risk difference 0.6%; 95% confidence interval -4.8% to 6.0%). The contrast-induced nephropathy rate in patients receiving less than 1 L intravenous fluids in the emergency department (ED) was 19 of 147 (12.9%) versus 7 of 210 (3.3%) for greater than 1 L intravenous fluids (difference 9.6%; 95% confidence interval 3.7% to 15.5%), a 69% risk reduction (odds ratio 0.41; 95% confidence interval 0.21 to 0.80) per liter of intravenous fluids. CONCLUSION: We did not find evidence of a benefit for N-acetylcysteine administration to our ED patients undergoing contrast-enhanced CT. However, we did find a significant association between volume of intravenous fluids administered and reduction in contrast-induced nephropathy.
RCT Entities:
STUDY OBJECTIVE: We test the hypothesis that N-acetylcysteine plus normal saline solution is more effective than normal saline solution alone in the prevention of contrast-induced nephropathy. METHODS: The design was a randomized, double blind, 2-center, placebo-controlled interventional trial. Inclusion criteria were patients undergoing chest, abdominal, or pelvic computed tomography (CT) scan with intravenous contrast, older than 18 years, and at least one contrast-induced nephropathy risk factor. Exclusion criteria were end-stage renal disease, pregnancy, N-acetylcysteine allergy, or clinical instability. Intervention for the treatment group was N-acetylcysteine 3 g in 500 mL normal saline solution as an intravenous bolus and then 200 mg/hour (67 mL/hour) for up to 24 hours; and for the placebo group was 500 mL normal saline solution and then 67 mL/hour for up to 24 hours. The primary outcome was contrast-induced nephropathy, defined as an increase in creatinine level of 25% or 0.5 mg/dL, measured 48 to 72 hours after CT. RESULTS: The data safety and monitoring board terminated the study early for futility. Of 399 patients enrolled, 357 (89%) completed follow-up and were included. The N-acetylcysteine plus saline solution group contrast-induced nephropathy rate was 14 of 185 (7.6%) versus 12 of 172 (7.0%) in the normal saline solution only group (absolute risk difference 0.6%; 95% confidence interval -4.8% to 6.0%). The contrast-induced nephropathy rate in patients receiving less than 1 L intravenous fluids in the emergency department (ED) was 19 of 147 (12.9%) versus 7 of 210 (3.3%) for greater than 1 L intravenous fluids (difference 9.6%; 95% confidence interval 3.7% to 15.5%), a 69% risk reduction (odds ratio 0.41; 95% confidence interval 0.21 to 0.80) per liter of intravenous fluids. CONCLUSION: We did not find evidence of a benefit for N-acetylcysteine administration to our ED patients undergoing contrast-enhanced CT. However, we did find a significant association between volume of intravenous fluids administered and reduction in contrast-induced nephropathy.
Authors: Shu Min Tao; Julian L Wichmann; U Joseph Schoepf; Stephen R Fuller; Guang Ming Lu; Long Jiang Zhang Journal: Eur Radiol Date: 2015-12-18 Impact factor: 5.315
Authors: Aart J van der Molen; Peter Reimer; Ilona A Dekkers; Georg Bongartz; Marie-France Bellin; Michele Bertolotto; Olivier Clement; Gertraud Heinz-Peer; Fulvio Stacul; Judith A W Webb; Henrik S Thomsen Journal: Eur Radiol Date: 2018-02-07 Impact factor: 5.315