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Prevention guidelines for contrast-induced nephropathy in contrast-enhanced CT: Appropriate and cost-effective? The Amsterdam, Maastricht, Alkmaar, Contrast Induced Nephropathy-Guideline study (the AMACING study)

Prevention guidelines for contrast-induced nephropathy in contrast-enhanced CT: Appropriate and cost-effective? The Amsterdam, Maastricht, Alkmaar, Contrast Induced Nephropathy-Guideline study (the AMACING study) - The AMACING study

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38644
Enrollment
2000
Registered
2013-07-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute kidney injury acute renal failure

Interventions

In the randomized controlled trial patients will be randomized to receive standard care, i.e. prophylactic intravenous hydration before and after intravenous iodinated contrast medium administration

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All patients aged 18 years and above, scheduled to undergo elective contrast enhanced computed tomography (no emergency department or intensive care unit) with intravenous iodinated contrast material administration. Patients with an indication for prophylactic intravenous hydration according to one of the Dutch CIN prevention guidelines will be eligible for randomization. Indication is defined as: eGFR 30-44 ml/min/1.73m2; eGFR 45-59 ml/min/1.73m2 & diabetes mellitus or * 2 risk factors; Kahler*s disease (multiple myeloma) / Waldenström*s macroglobulinemia with small chain proteinuria. Risk factors include: age >75, anaemia, use of nephrotoxic medication, cardiac or peripheral vascular disease.

Exclusion criteria

Exclusion criteria: Patients will only be included once in the RCT; no repeat inclusion for additional contrast enhanced CT examinations will occur.

Design outcomes

Primary

MeasureTime frame
The primary endpoint of the cohort study and randomized trial is the net number of CIN cases prevented.

Secondary

MeasureTime frame
The secondary endpoints are: cost effectiveness of screening and prevention. Health-related quality of life, complications of intravenous hydration and morbidity and mortality up to 30 days after iodinated contrast material administration.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)