Acute Kidney Injury in Patients Undergoing Contrast Exposure: VQ vs. CT
A legfontosabb adatok
- Ki végzi
- Indiana University
- Hol
- Dallas, Indianapolis, Murray, Royal Oak és Salt Lake City (Egyesült Államok)Mind a 5 helyszín megnézése
- Azonosító
- Állapot
- Leállítva
- Résztvevők
- 253 fő vett részt
- Kezdés
- 2017. júl. 20.
- Befejezés
- 2024. márc. 27.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- V/Q imaging
- Computed tomography scan
- A regiszteradat frissítve
- 2026. március 23.
- Miért állt le
- Study funding ended prior to planned study accrual and prior to planned completion of all enrolled subjects.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 11 feltétel megnézéseKevesebb
Ki vehet részt
- Age≥18 years
- CTPA ordered by the treating provider to evaluate PE
- Pre-test probability of PE ≤20% (defined using the PE Pretest Consult Score)
- For Randomization to CTPA or VQ imaging: Pre-imaging CIN risk ≥25% (CINRisk Score ≥2 points) • A lower-risk subset of 100 patients (CINRisk Score <2) will be enrolled and followed. These patients will complete the CTPA as ordered by their provider (not randomized). Data from this lower-risk subset, along with high-risk patients randomized to CTPA will be used will be used to validate the CINRisk Score, alone and in combination with NGAL and eGFRCYS (Study Aims 1 and 3)
Ki nem vehet részt
- Active renal replacement therapy (hemodialysis or peritoneal dialysis) within 30-days of enrollment or previous physician-directed plans to initiate dialysis within 30-days of the index visit
- Prior renal transplant or planned within 30-days of enrollment
- Intravascular contrast administration within 14 days prior to enrollment or planned within 7 days of enrollment
- History of pulmonary surgery or pulmonary infiltrate, mass or effusion on chest radiograph
- Subject unavailability for reasonable follow-up including biological sample collection, serum creatinine measurement, and interview, such as an insecure residence, planned travel or absence, personal or professional obligations, incarceration, and/or other reason preventing follow-up, identified at enrollment
- Clinical instability preventing randomization to CTPA or VQ imaging
- Pregnancy or ≤48 hours post-partum
Helyszínek itt: Egyesült Államok
- Baylor Scott & White HealthDallas, Egyesült Államok
- Indiana University HealthIndianapolis, Egyesült Államok
- Intermountain HealthcareMurray, Egyesült Államok
- Corewell HealthRoyal Oak, Egyesült Államok
- University of UtahSalt Lake City, Egyesült Államok
A vizsgálatról
Mit akar kideríteni a vizsgálat
Both, CT scans and VQ scans, are used by doctors to look for pulmonary embolism. The most common reason to order a VQ scan is to avoid the IV dye. The IV dye used for CT scans can cause kidney problems in some patients, called contrast-induced nephropathy or "CIN." This is a kidney problem that usually does not make patients feel any differently or change how they urinate. Most of the time, it can only be found by testing blood several days later. This kind of kidney problem can be very mild and some patients will never have any symptoms, rarely these problems can be severe. Some patients can also have similar kidney problems for many other reasons (reactions to medications, blood pressure problems, etc.) and can even happen in patients that do not get IV dye. That is why doctors are not sure exactly who will have these problems or if using a test that does not use IV dye can prevent this kidney problem. The VQ scan uses a different medication through the IV that is not IV dye and has not been linked to kidney problems. The purpose of this study is to learn if using the test that does not use IV dye (the "VQ scan") instead of a CT scan in some patients can help to prevent kidney problems.
A vizsgálat 2 csoportja
- Randomized to V/QMár használt kezelés, összehasonlításként
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control)
Kezelés: V/Q imaging
- Randomized to CTMár használt kezelés, összehasonlításként
Patients with \> 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Kezelés: Computed tomography scan
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- 1 R01 HL132358: The Contribution of Contrast Media Exposure to Acute Kidney Injury in Patients Evaluated for Pulmonary Embolism in the Emergency Care Setting: a Prospective, Randomized Trial
- A regiszteradat frissítve
- 2026. március 23.