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Time to Excretion of Contrast, a Maastricht Prospective Observational Study

Time to Excretion of Contrast, a Maastricht Prospective Observational Study - TEMPOS

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50819
Enrollment
144
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: In order to be eligible to participate in this study, a subject must meet all of the following criteria - referred for an elective procedure with intravascular administration of iodinated contrast material at Maastricht UMC+ - age, sex and contrast procedure type match the age, sex and contrast procedure type of an eGFR =60 mL/min/1.73m2

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: age

Design outcomes

Primary

MeasureTime frame
The primary outcome is time to contrast-free urine, i.e., time to the first contrast-free urine sample from the time of intravascular iodinated contrast administration.

Secondary

MeasureTime frame
A secondary outcome is the percentage of contrast eliminated, i.e., percentage of total contrast administered excreted in urine within 5 days. Relevant characteristics of patients and procedures will be recorded to identify patients at increased risk of delayed contrast elimination. 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. To evaluate the relationship between elimination time and adverse post-contrast outcomes therefore, post-contrast incidences of classic and KDIGO definitions of acute kidney injury will be determined. The following definitions for acute kidney injury will be used, based on baseline serum creatinine values (visit 1.0) and peak serum creatinine changes from baseline (visits 1.1-1.5; see Table 1): - an increase in serum creatinine greater than 44umol/l or 25% from baseline (classic) - an increase in serum creatinine greater than 26.5 umol/L from baseline or more than 1.5 times the baseline value (KDIGO) In addition, post-contrast changes in eGFR within 5 days from baseline; 1-month post-contrast change in eGFR; and 1-month post-contrast incidences of eGFR decline >=5 mL/min/1.73m2, dialysis and mortality will be recorded. Time to peak change in serum creatinine within 5 days post-contrast will also be determined. 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)