ABSTRACT
BACKGROUND: Despite an often favorable risk/benefit ratio, patients with severe chronic kidney disease are sometimes declined for interventional coronary procedures, due to the risk of acute kidney injury post-contrast (AKI-PC). A large preventive supply of intravenous fluid may be problematic in this population. The RenalGuard® system allows hyperhydration by maintaining a stable volemia through an enhanced diuresis. METHODS AND RESULTS: This work reports the evaluation of the RenalGuard® system in 25 consecutive patients with chronic kidney disease (glomerular filtration rate < 40 mL/min/1.73 m²) requiring an interventional coronary procedure (coronary angiography and/or percutaneous coronary intervention) and at high risk of IRA-PC. An increase in serum creatinine ≥ 26.5 µmol/L at 48-72 hours (AKI-PC definition) was observed in 4 patients (16%). The mean glomerular filtration rate was 26 ± 8 mL/min/1.73 m² at 48-72 hours versus 25 ± 8 mL/min/1.73 m² at baseline. No patient presented with an increase in serum creatinine ≥ 1.5 from baseline, stage 2 or 3 AKI, or acute pulmonary edema. No renal replacement therapy was necessary. One death unrelated to AKI-PC occurred during hospital stay. CONCLUSIONS: This single-center observational study suggests that the RenalGuard® system, allowing diuresis-adjusted hyperhydration, is safe and useful for patients at high risk of AKI-PC after an interventional coronary procedure.
Subject(s)
Acute Kidney Injury , Percutaneous Coronary Intervention , Renal Insufficiency, Chronic , Humans , Creatinine , Contrast Media/adverse effects , Risk Factors , Acute Kidney Injury/chemically induced , Acute Kidney Injury/prevention & control , Percutaneous Coronary Intervention/adverse effects , Coronary Angiography/adverse effectsABSTRACT
BACKGROUND: Neutrophil gelatinase-associated lipocalin (NGAL) is a recognised biomarker for acute kidney injury (AKI).This study investigated the impact of balanced forced-diuresis using RenalGuard® system (RG), in reducing acute kidney injury (AKI) rates and the associated NGAL levels (6-h post-CPB plasma level) post adult cardiac surgery with cardiopulmonary bypass (CPB). METHODS: Patients included in the study were at high-risk for AKI post cardiac surgery, namely history of diabetes and/or anaemia, e-GFR 20-60 ml/min/1.73 m2, Logistic EuroScore > 5, anticipated CPB time > 120 min. Patients were randomized to either RG (n = 110) or managed as per current practice (control = 110). RIFLE-defined AKI rate (based on serum creatinine level increase) within first 3 days of surgery and 6-h post CPB NGAL levels were the primary and secondary end-points. RESULTS: Pre and intra-operative characteristics between the two groups were similar (p > 0.05) including the pre-op NGAL levels, the oxygen delivery (ecDO2i) and the carbon dioxide production (ecVCO2i) during CPB. Patients in the RG group had a significantly lower post-operative RIFLE-defined AKI rate compared to control (10% (11/110) v/s 20.9% (23/110), p = 0.03). Overall, median 6-h post CPB NGAL levels in patients with AKI were significantly higher than those who did not develop AKI (211 vs 150 ng/ml, p < 0.001). Patients managed by balanced forced-diuresis had lower post-operative NGAL levels (146 vs 178 ng/ml, p = 0.09). Using previously reported NGAL cut-off level for AKI (142 ng/ml), binary logistic regression analysis confirmed a beneficial effect of the RG system, with an increased risk of AKI of 2.2 times in the control group (OR 2.2, 95% CI 1.14-4.27, p = 0.02). CONCLUSIONS: Overall, the 6-h post-CPB plasma NGAL levels were significantly higher in patients who developed AKI. Patients managed with the novel approach of balanced forced-diuresis, provided by the RenalGuard® system, had a lower AKI rate and lower NGAL levels indicating a lesser degree of renal tissue injury. Trial registration ClinicalTrials.gov website, NCT02974946, https://clinicaltrials.gov/ct2/show/NCT02974946 .
Subject(s)
Acute Kidney Injury , Cardiac Surgical Procedures , Acute Kidney Injury/diagnosis , Acute Kidney Injury/etiology , Acute Kidney Injury/prevention & control , Acute-Phase Proteins , Adult , Biomarkers , Cardiac Surgical Procedures/adverse effects , Creatinine , Diuresis , Humans , Lipocalin-2 , Lipocalins , Predictive Value of Tests , Proto-Oncogene ProteinsABSTRACT
BACKGROUND: Contrast-associated acute kidney injury (CA-AKI) can increase the mortality of patients undergoing transcatheter aortic valve replacement (TAVR) or percutaneous coronary intervention (PCI). The purpose of this paper was to compare the efficacy of the RenalGuard System and conventional hydration regimen in preventing CA-AKI in patients with TAVR or PCI. METHODS: We searched PubMed, Embase, Web of Science, and the Cochrane Central Register of Clinical Trials (last updated July 11, 2020) for suitable reports. The primary outcome was the occurrence of CA-AKI. The secondary outcomes were renal replacement therapy (RRT), major cardiovascular events (MACEs), and other adverse complications. RESULTS: The search strategy yielded 270 studies (with data for 2067 participants). In the subgroup of PCI, low incidence of CA-AKI (6.7% vs 15.7%; 95%CI: 0.27 to 0.54; I2 = 8%; P < 0.00001) associate with RenalGuard group (RG) rather than control group (CG). Similarly, in the subgroup of TAVR, a low incidence of CA-AKI (15.6% vs 26.9%; 95%CI: 0.35 to 0.82; I2 = 88%; P = 0.004) relates to RG. However, this result is highly heterogeneous. Compare with conventional hydration, RenalGuard significantly reduce the incidence of pulmonary edema (1.5%vs4.1%; 95%CI: 0.18 to 0.72; I2 = 0%; P = 0.004). CONCLUSIONS: RenalGuard System can lessen the risk of CA-AKI and RRT in patients undergoing PCI. But for patients experiencing TAVR, due to unique hemodynamic effects, the role of RenalGuard remains questionable. RenalGuard is more secure than conventional hydration. Future work should elucidate the feasibility and safety of this prophylactic intervention in cardiac interventional therapy.