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NO During CPB in Neonates to Reduce Risk of AKI

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jun 30, 2026 → Jun 30, 2027
See other at-risk trials from Children's Hospital Medical Center, Cincinnati

Record History

  1. Primary and study completion pushed from Jun 30, 2026 to Jun 30, 2027v12
  2. Primary and study completion dates: Jun 30, 2025 to Jun 30, 2026v11
  3. Primary completion date: Dec 31, 2024 to Jun 30, 2025 Completion date: Jun 1, 2025 to Jun 30, 2025 · Site contact updatedv10 Show 2 more changesShow less
    • Completion date: Jun 1, 2025 to Jun 30, 2025
    • Site contact updated
  4. Re-verified, no change to tracked fieldsv9
  5. Start date changed from estimate of Jan 30, 2023 to Jan 10, 2023v8
Show 6 earlier versionsHide 6 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting Start date: Sep 30, 2022 to Jan 30, 2023 · Site details revisedv7 Show 2 more changesShow less
    • Start date: Sep 30, 2022 to Jan 30, 2023
    • Site details revised
  2. Start date: Jul 1, 2022 to Sep 30, 2022 Trial status: Recruiting to Not Yet Recruiting · Site details revisedv6 Show 2 more changesShow less
    • Trial status: Recruiting to Not Yet Recruiting
    • Site details revised
  3. Primary completion date: Dec 31, 2021 to Dec 31, 2024 Start date: Jun 1, 2021 to Jul 1, 2022 · Completion date: Jun 1, 2022 to Jun 1, 2025v5 Show 2 more changesShow less
    • Start date: Jun 1, 2021 to Jul 1, 2022
    • Completion date: Jun 1, 2022 to Jun 1, 2025
  4. Start date changed from estimate of Jan 30, 2021 to Jun 1, 2021v4
  5. Primary completion date: Dec 31, 2020 to Dec 31, 2021 Start date: Jan 30, 2020 to Jan 30, 2021 · Completion date: Jun 1, 2021 to Jun 1, 2022 · Study title revisedv3 Show 3 more changesShow less
    • Start date: Jan 30, 2020 to Jan 30, 2021
    • Completion date: Jun 1, 2021 to Jun 1, 2022
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  6. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Acute kidney injury (AKI) following cardiac surgery for congenital heart defects (CHD) in children affects up to 60% of high risk-patients and is a major cause of both short- and long-term morbidity and mortality. Despite effort, to date, no successful therapeutic agent has gained widespread success in preventing this postoperative decline in renal function. Nitric oxide is an intricate regulator of acute inflammation and coagulation and is a potent vasodilator. The investigators hypothesize that nitric oxide, administered during cardiopulmonary bypass (CPB), may reduce the incidence of AKI.
Trial Details
NCT Number NCT04216927
Lead Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators: Mallinckrodt, Indiana University
Conditions AKI, CHD - Congenital Heart Disease, Surgery
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov