Renal insufficiency following contrast media administration trial III: Urine flow rate‐guided versus left‐ventricular end‐diastolic pressure‐guided hydration in high‐risk patients for contrast‐induced acute kidney injury. Rationale and design. Issue 5 (8th July 2019)

• Record Type: Journal Article
• Authors: Briguori, Carlo; D'Amore, Carmen; De Micco, Francesca; Signore, Nicola; Esposito, Giovanni; Napolitano, Giovanni; Focaccio, Amelia
• Is Part Of: Catheterization and cardiovascular interventions. Volume 95:Issue 5(2020)
• Page Start: 895
• Page End: 903
• Publication Date: 2019-07-08
• Subjects: CLIN—clinical trials -- COMD—complications -- COMI—complications -- CONT—contrast agents -- diagnostic catheterization -- PCI; Heart -- Diseases -- Diagnosis -- Periodicals; Cardiac catheterization -- Periodicals; 616.1207572
• DOI: 10.1002/ccd.28386
• Languages: English
• ISSNs: 1522-1946

Abstract

Abstract : Background: Urine flow rate (UFR)‐guided and left‐ventricular end‐diastolic pressure (LVEDP)‐guided hydration regimens have been proposed to prevent contrast‐induced acute kidney injury (CIAKI). The REnal Insufficiency Following Contrast MEDIA Administration triaL III (REMEDIAL III) is a randomized, multicenter, investigator‐sponsored trial aiming to compare these two hydration strategies. Methods: Patients at high risk for CIAKI (that is, those with estimated glomerular filtration rate ≤ 45 mL/min/1.73 m 2 and/or with Mehran's score ≥11 and/or Gurm's score >7) will be enrolled. Patients will be randomly assigned to (a) LVEDP‐guided hydration with normal saline ( LVEDP‐guided group ) and (b) UFR‐guided hydration carried out by the RenalGuard system ( RenalGuard group ). Seven‐hundred patients (350 in each arm) will be enrolled. In the LVEDP‐guided group the fluid infusion rate will be adjusted according to the LVEDP as follows: 5 mL kg −1 hr −1 for LVEDP ≤12 mmHg, 3 mL kg −1 hr −1 for LVEDP 13–18 mmHg, and 1.5 mL kg −1 hr −1 for LVEDP >18 mmHg. In the RenalGuard group hydration with normal saline plus low‐dose of furosemide is controlled by the RenalGuard system, in order to reach and maintain a high (>300 mL/hr) UFR. In all cases, iobitridol (a low‐osmolar, nonionic contrast agent) will be administered. Results: The primary endpoint is the composite of CIAKI (i.e., serum creatinine increase ≥25% and/or ≥0.5 mg/dL from the baseline to 48 hr after contrast media exposure) and/or acute pulmonary edema. Conclusion: The REMEDIAL III will test the hypothesis that the UFR‐guided hydration is superior to the LVEDP‐guided hydration to prevent the composite of CIAKI and/or acute pulmonary edema.