Prophylactic Intravenous Hydration to Protect Renal Function From Intravascular Iodinated Contrast Material (AMACING): Long-term Results of a Prospective, Randomised, Controlled Trial

Abstract

Background: The aim of A MAastricht Contrast-Induced Nephropathy Guideline (AMACING) trial was to evaluate non-inferiority of no prophylaxis compared to guideline-recommended prophylaxis in preventing contrast induced nephropathy (CIN), and to explore the effect on long-term post-contrast adverse outcomes. The current paper presents the long-term results.

Methods: AMACING is a single-centre, randomised, parallel-group, open-label, phase 3, non-inferiority trial in patients with estimated glomerular filtration rate [eGFR] 30-59 mL/min/1.73 m2 combined with risk factors, undergoing elective procedures requiring intravenous or intra-arterial iodinated contrast material. Exclusion criteria were eGFR < 30 mL/min/1.73 m2, dialysis, no referral for prophylaxis. The outcomes dialysis, mortality, and change in renal function at 1 year post-contrast were secondary outcomes of the trial. Subgroup analyses were performed based on pre-defined stratification risk factors. AMACING is registered with ClinicalTrials.gov: NCT02106234.

Findings: From 28,803 referrals, 1120 at-risk patients were identified. 660 consecutive patients agreed to participate and were randomly assigned (1:1) to no prophylaxis (n = 332) or standard prophylactic intravenous hydration (n = 328). Dialysis and mortality data were available for all patients. At 365 days post-contrast dialysis was recorded in two no prophylaxis (2/332, 0.60%), and two prophylaxis patients (2/328, 0.61%; p = 0.9909); mortality was recorded for 36/332 (10.84%) no prophylaxis, and 32/328 (9.76%) prophylaxis patients (p = 0.6490). The hazard ratio was 1.118 (no prophylaxis vs prophylaxis) for one-year risk of death (95% CI: 0.695 to 1.801, p = 0.6449). The differences in long-term changes in serum creatinine were small between groups, and gave no indication of a disadvantage for the no-prophylaxis group.

Interpretation: Assuming optimal contrast administration, not giving prophylaxis to elective patients with eGFR 30-59 mL/min/1.73 m2 is safe, even in the long-term.

Funding: Stichting de Weijerhorst.

Keywords: Clinical practice guidelines; Contrast-associated acute kidney injury; Contrast-induced nephropathy; Intravascular iodinated contrast administration; Prophylactic intravenous hydration.

Figures

Fig. 1

Trial profile. MUMC + = Maastricht University Medical Centre; eGFR = estimated glomerular filtration rate. H + group = received standard 0.9% NaCl prophylactic intravenous hydration. H − group = received no prophylaxis. *Our institution follows the screening guidelines that propose renal function needs only be assessed if one of the following risk factors is present: age > 60 years, diabetes mellitus, use of nephrotoxic medication, urologic or nephrologic history, hypertension, peripheral vascular/cardiac disease, multiple myeloma/lymphoplasmacytic lymphoma.

Fig. 2

Kaplan–Meier Survival Plot for the standard prophylactic treatment (H +) and no prophylactic treatment (H −) groups. Hazard ratio for 1-year risk of death 1.118 (95% CI 0.695 to 1.801, n = 660, p = 0.6449).

Fig. 3

Observed mean serum creatinine and changes in serum creatinine in the standard prophylactic treatment (H +) and no prophylactic treatment (H −) groups. Error bars show standard deviations.