AMACING
Trial question
Is no prophylaxis noninferior to intravenous prophylactic hydration treatment in patients at high risk of contrast-induced nephropathy?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 660
660 patients (253 female, 407 male).
Inclusion criteria: high-risk patients aged ≥ 18 years undergoing an elective procedure requiring iodinated contrast material administration.
Key exclusion criteria: eGFR < 30 mL/min/1.73 m²; previous dialysis; no referral for intravenous hydration.
Interventions
N=332 no prophylaxis (no intravenous prophylactic hydration).
N=328 prophylactic hydration (prophylactic intravenous hydration with normal saline).
Primary outcome
Contrast-induced nephropathy
2.6%
2.7%
2.7 %
2.0 %
1.4 %
0.7 %
0.0 %
No
prophylaxis
Prophylactic
hydration
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in contrast-induced nephropathy (2.6% vs. 2.7%; ARD -0.1, 95% CI -2.25 to 2.06).
Secondary outcomes
Significant decrease in cost-effectiveness (792 EUR vs. 1455 EUR; AD -663 EUR, 95% CI -1234 to -191).
No significant difference in renal function decline of > 10 eGFR at 26-35 days (4.2% vs. 2.7%; AD 1.5%, 95% CI -1.6 to 4.68).
No significant difference in renal function decline to eGFR < 30 ml/min/1.73 m² at 26-35 days (2.3% vs. 2.7%; AD -0.4%, 95% CI -3.07 to 2.3).
Safety outcomes
No significant differences in death, hyponatremia, and arrhythmia.
Significant difference in symptomatic HF (0% vs. 4%).
Conclusion
In high-risk patients aged ≥ 18 years undergoing an elective procedure requiring iodinated contrast material administration, no prophylaxis was noninferior to prophylactic hydration with respect to a contrast-induced nephropathy.
Reference
Estelle C Nijssen, Roger J Rennenberg, Patty J Nelemans et al. Prophylactic hydration to protect renal function from intravascular iodinated contrast material in patients at high risk of contrast-induced nephropathy (AMACING): a prospective, randomised, phase 3, controlled, open-label, non-inferiority trial. Lancet. 2017 Apr 1;389(10076):1312-1322.
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