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Maastricht Investigation of Renal function in Absence of- and post- Contrast in patients with estimated glomerular filtration rate LEss than 30mL/min/1.73m2 (MIRACLE)

Maastricht Investigation of Renal function in Absence of- and post- Contrast in patients with estimated glomerular filtration rate LEss than 30mL/min/1.73m2 (MIRACLE) - MIRACLE

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54949
Enrollment
72
Registered
2021-05-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-09

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

Conditions

post-contrast acute kidney injury

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with eGFR

Exclusion criteria

Exclusion criteria: age

Design outcomes

Primary

MeasureTime frame
In the context of post-contrast acute kidney injury, change in serum creatinine is the gold standard recommended in all (inter)national guidelines on safe use of iodinated contrast material. The primary outcome of the current study is peak changes in serum creatinine within 5 days from a baseline measurement, determined within prespecified periods (see Section J, Table 1). The effect of contrast administration will be expressed as the mean intra-patient difference in peak changes in serum creatinine between 5-day pre- and post-contrast periods.

Secondary

MeasureTime frame
Other outcomes are peak changes in serum creatinine occurring at 1 month post-contrast compared to those occurring in absence of contrast; time to post-contrast peak change in serum creatinine; incidences of classic and KDIGO definitions of acute kidney injury in absence of contrast compared to post-contrast; changes in eGFR within 5 days from baseline in absence of and post-contrast; change in eGFR at 1-month post-contrast; incidences of eGFR decline >=5 mL/min/1.73m2, dialysis and mortality at 1-month post-contrast; and time to naturally excreted contrast-free urine. Finally, samples will be stored in order to determine serum contrast (patients with retention or

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)