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Individualized Versus Conventional Perioperative Blood Pressure Management

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Eligibility criteria expanded, about 15 words · Secondary endpoints: details revised at 1 of 9 entries · Site details revised at 5 of 5 sites · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 9 entries
    • Site details revised at 5 of 5 sites
    • Publications: details revised at 1 of 1 entry
  2. Re-verified, no change to tracked fieldsv8
  3. Primary completion date: Aug 31, 2026 to Nov 30, 2026 Completion date: Sep 30, 2026 to Dec 31, 2026v7 Show 1 more changeShow less
    • Completion date: Sep 30, 2026 to Dec 31, 2026
  4. Site contacts updated at 1 of 5 sitesv6
  5. Site details revised at 3 of 5 sitesv5
Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Eligibility criteria expanded, about 3 words Study description expanded, about 1 wordv3 Show 1 more changeShow less
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 5 · Start date changed from estimate of Mar 2, 2024 to Jan 29, 2024v2 Show 2 more changesShow less
    • Study sites: 1 to 5
    • Start date changed from estimate of Mar 2, 2024 to Jan 29, 2024
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Study objective: To compare the effect of different perioperative blood pressure management strategies on major postoperative adverse outcomes / Study design: a multicenter, randomized controlled trial / Participants: 1896 patients undergoing major non-cardiac surgery / Methods: Patients are randomized into two groups, the individualized strategy (maintaining perioperative mean arterial pressure and systolic blood pressure more than -20% of their baseline values) or the conventional strategy (maintaining perioperative mean arterial pressure ≥65 mmHg and systolic blood pressure ≥90 mmHg in all patients). Then, the frequency of major postoperative adverse outcomes occurring within 7 postoperative days or before discharge (whichever occurs first). / Primary outcome: a composite of all-cause death, stroke, myocardial infarction, new or worsening congestive heart failure, unplanned coronary revascularization, and acute kidney injury, occuring within 7 postoperative days or before discharge (whichever occurs first).
Trial Details
NCT Number NCT06225453
Lead Sponsor Seoul National University Hospital
Conditions Major Non-cardiac Surgery
Enrollment 1,896 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov