Ultra-Low Contrast Angiography in AKI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Angiography.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Controlled Trial of Ultra-Low Contrast Coronary Angiography During Acute Kidney Injury (AKI)
Overview
The aim of this study is to evaluate the safety of ultra-low contrast coronary angiography in patients with pre-existing acute kidney injury.
Detailed description
The study is a non-inferiority open-label randomized controlled trial. Hospitalized patients who have AKI at admission or who develop AKI during admission and require invasive coronary angiography will be included in the trial. Once indication for invasive coronary angiography is determined, patients will be randomized to immediate angiography or to delayed angiography after renal function stabilizes. Immediate angiography will be performed within 24 of enrollment. Serum creatinine will be collected on enrollment, within 6 hours before coronary angiography, and at 24h, 48h and 1-week after the angiography, as expected in common practice. Pre- and post-hydration administration will be at the discretion of the treating physician. In case percutaneous coronary intervention is indicated it will be schedule for 7 days after angiography.
Definitions: AKI is defined as an increase in serum creatinine by ≥50% from baseline within 7 days or an increase in serum creatinine by ≥0.3 mg/dl within 2 days. CIN is defined as an increase in serum creatinine by 0.5mg/dl or a relative rise of 25% from the baseline value.
Interventions
- Procedure Angiography
Coronary angiography with less than 20cc of contrast materials
Primary outcome measures
- Change in incidence of Contrast Induced Nephropathy (CIN) [Time frame: Within 7 days]
Secondary outcome measures (2)
- Incidence of earlier occurrence of CIN [Time frame: Within 7 days]
- Incidence of renal replacement therapy at up to 7 days post-angiography [Time frame: Within 7 days]
Eligibility criteria
Inclusion criteria
- Hospitalized patients who have AKI at admission or who develop AKI during admission and require invasive coronary angiography will be included in the trial.
Exclusion criteria
- Stabilized renal function manifested by unchanged or downtrending serum creatinine during a 24-hour period prior to enrollment.
- Contraindication for invasive coronary angiography other than AKI.
- Percutaneous coronary intervention is indicated and cannot be postponed by 7 days.
- Need for renal replacement therapy before coronary angiography or planned renal replacement therapy after coronary angiography (if premeditated before coronary angiography).
- Administration of intravascular contrast media during 7 days prior to the coronary angiography or within 6 days after coronary angiography.
- Pregnant patients, prisoners, cognitively impaired subjects, age below 18 years, unable or unwilling to provide informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Tulane University Medical Center — New Orleans
- University Medical Center — New Orleans
Identifiers
NCT: NCT05906758 · 2023-874