Bioimpedance Analysis–Guided Volume Expansion for the Prevention of Contrast-Induced Acute Kidney Injury (the BELIEVE Pilot Randomized Controlled Trial)

Abstract

Introduction: Peri-procedural i.v. fluid administration is important for the prevention of contrast-induced acute kidney injury (CI-AKI). However, standardized fluid management protocols may not be suitable for all patients. We therefore wished to determine whether an individualized fluid administration protocol guided by measuring extracellular water (ECW) using bioimpedance analysis (BIA) would be safe and would reduce the incidence CI-AKI compared to a standardized fluid administration prescription. Methods: In this pilot, randomized, parallel-group, single-blind, controlled trial, we compared the effect of BIA-guided isotonic bicarbonate administration according to the ratio of ECW to total body water (ECW/ TBW) to our standard isotonic bicarbonate protocol in regard to the safety and efficacy of preventing CI-AKI in chronic kidney disease patients undergoing elective cardiac angiography. Our primary outcome was the incidence of CI-AKI, which was defined as a $0.3 mg/dl or 150% increase in serum creatinine concentration within 48 to 72 hours after cardiac angiography. Results: We studied 61 patients, 30 in the bioimpedance group and 31 in the control group. Age was similar (72.5 AE 7 vs. 71.4 AE 7.9 years), as were body mass index (25.5 vs. 25.8 kg/m 2) and baseline serum creatinine (1.3 AE 0.3 vs. 1.4 AE 0.4 mg/dl). The peri-procedural fluid volume administered was significantly greater in the BIA-guided hydration group (899.0 AE 252.7 ml vs. 594.4 AE 125.9 ml, P < .01). The incidence of CI-AKI was 3.3% in BIA-guided hydration group and 6.5% in the control group (relative risk ¼ 0.52, 95% confidence interval ¼ 0.05À5.40, P ¼ 1.00). Adverse events reported were comparable between groups (6.7% vs. 6.5%, P ¼ 1.00). Conclusions: The overall incidence of CI-AKI after cardiac angiography in our patients with mild-tomoderate renal insufficiency was lower than anticipated. Isotonic bicarbonate administration guided by bioimpedance measurements was safe, and probably led to a lower incidence of CI-AKI, although this not reach statistical significance.

Performance of contrast-associated acute kidney injury predictive risk models in Thai cardiac angiography or angioplasty patients

“…Baseline renal function as eGFR or CrCl of the patients were lower to our patients in three studies that included only patients with CKD [41][42][43] , not differ from our patients in two studies 13,39 , and better than our patients in one study 44 . Most studies included more patients with hypertension, diabetes mellitus, and dyslipidemia 13,[39][40][41][42][43][44] . Low osmolar contrast agents were mainly used in all studies 13,[39][40][41][42][43][44] , recommended and preferred by the Society for Cardiovascular Angiography and Interventions (SCAI) 6,46 .…”

“…Lastly, this was a single-center study, so generalizing our findings to the different populations should be done with caution. Compared to CA-AKI studies in Thai elective cardiac angiography or angioplasty patients, all the studies were small (n=61-305) and done in medical schools from 2008 to 2016 13,[39][40][41][42][43][44] . These studies usually selected high-risk groups as those with diabetes mellitus 44 or chronic kidney disease [41][42][43] , and aimed to investigate the effectiveness of preventive measures of CA-AKI 39,41,43 .…”

“…Compared to CA-AKI studies in Thai elective cardiac angiography or angioplasty patients, all the studies were small (n=61-305) and done in medical schools from 2008 to 2016 13,[39][40][41][42][43][44] . These studies usually selected high-risk groups as those with diabetes mellitus 44 or chronic kidney disease [41][42][43] , and aimed to investigate the effectiveness of preventive measures of CA-AKI 39,41,43 . One prospective study validated Mehran's risk score for CA-AKI after cardiac angiography or angioplasty 13 , the most well-known procedural risk model 45 .…”

“…It may be appropriate to use the predictive risk of CA-AKI in Thai patients after the procedure if Mehran's predictive risk model has highly discriminating capability in the large sample size and the standardized CA-AKI definitions used. Overall, patients in these studies were older than our patients, and there were male more than females 13,[39][40][41][42][43][44] . Baseline renal function as eGFR or CrCl of the patients were lower to our patients in three studies that included only patients with CKD [41][42][43] , not differ from our patients in two studies 13,39 , and better than our patients in one study 44 .…”

“…Overall, patients in these studies were older than our patients, and there were male more than females 13,[39][40][41][42][43][44] . Baseline renal function as eGFR or CrCl of the patients were lower to our patients in three studies that included only patients with CKD [41][42][43] , not differ from our patients in two studies 13,39 , and better than our patients in one study 44 . Most studies included more patients with hypertension, diabetes mellitus, and dyslipidemia 13,[39][40][41][42][43][44] .…”