A MAstricht Contrast-Induced Nephropathy Guideline - AMACING

Apr 11, 2017
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Stichting de Weijerhorst
Date Published:
02/20/2017
Original Posted Date:
04/11/2017
References

Contribution To Literature:

The AMACING trial showed that no prophylactic hydration was noninferior to hydration at preventing contrast-induced nephropathy.

Description:

The goal of the trial was to evaluate prophylactic intravenous hydration compared with no hydration among patients at risk for contrast-induced nephropathy.

Study Design

  • Randomized
  • Parallel
  • Stratified

Patients with chronic kidney disease undergoing intravascular iodinated contrast administration were randomized to prophylactic hydration (n = 328) versus no hydration (n = 332). Patients in the hydration group could receive either 0.9% sodium chloride (NaCl) 3-4 cc/kg 4 hours before and 4 hours after contrast administration or 0.9% NaCl 1 cc/kg 12 hours before and 12 hours after contrast administration. All patients received iopromide (low osmolar contrast).

  • Total number of enrollees: 660
  • Duration of follow-up: 35 days
  • Mean patient age: 43% were >75 years
  • Percentage female: 41%
  • Percentage with diabetes: 32%

Inclusion criteria:

  • Patients with chronic kidney disease undergoing intravascular iodinated contrast administration
  • Estimated glomerular filtration rate (eGFR) 45-59 ml/min/1.73 m2, and diabetes or at least two risk factors (age >75 years; anemia; cardiovascular disease; current nonsteroidal anti-inflammatory drugs or diuretics), or eGFR 30-45 ml/min/1.73 m2, or multiple myeloma or lymphoplasmacytic lymphoma with small chain proteinuria

Exclusion criteria:

  • eGFR <30 ml/min/1.73 m2
  • Renal replacement therapy
  • Emergency procedures or intensive care patients
  • No referral for prophylactic hydration
  • Participation in another randomized trial
  • Isolation for an infectious disease

Other salient features/characteristics:

  • Inpatient: 9%
  • Mean eGFR: 47 ml/min/1.73 m2
  • Intra-arterial contrast: 48%
  • Mean contrast volume: 92 cc
  • Total intravenous hydration (includes pre- and post-administration): 1637 cc

Principal Findings:

The primary outcome, incidence of contrast-induced nephropathy, occurred in 2.7% of the hydration group versus 2.6% in the no hydration group (p = 0.47). The outcomes were the same among various tested subgroups.

Secondary outcomes:

  • No hydration was cost-effective vs. hydration
  • Renal failure: 0 vs. 0, for hydration vs. no hydration
  • All-cause mortality: 0 vs. 0.9%, for hydration vs. no hydration (p = 0.13)
  • Symptomatic heart failure: 4.0% vs. 0, for hydration vs. no hydration (p = 0.0001)

Interpretation:

Among patients with chronic kidney disease undergoing intravascular contrast administration, no hydration was noninferior to prophylactic hydration. Although not designed as a superiority trial, hydration did not appear to be effective at preventing contrast-induced nephropathy among high-risk patients. No hydration was cost-effective by preventing hospitalizations that otherwise would have occurred. Prophylactic hydration was associated with a higher frequency of symptomatic heart failure episodes versus no hydration. These findings apply to hemodynamically stable outpatients who received a relatively small amount of contrast (<100 cc). This important trial challenges current practice recommendations for such patients, but should not be extrapolated to unstable patients, emergency procedures, or administration of larger volumes of intravascular contrast (>100 cc).

References:

Nijssen EC, Rennenberg RJ, Nelemans PJ, 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, randomized, phase 3, controlled, open-label, non-inferiority trial. Lancet 2017;389:1312-22.

Keywords: Anemia, Contrast Media, Diabetes Mellitus, Diuretics, Glomerular Filtration Rate, Heart Failure, Kidney Failure, Chronic, Lymphoma, Multiple Myeloma, Proteinuria, Renal Insufficiency, Renal Insufficiency, Chronic, Primary Prevention, Risk Factors, Sodium Chloride


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