Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05168462 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction

Study acronym: NORSHOCK
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jun 1, 2025 to Apr 1, 2027 Completion date: Jun 1, 2026 to Apr 1, 2028 · Eligibility criteria expanded, about 5 wordsv5 Show 2 more changesShow less
    • Completion date: Jun 1, 2026 to Apr 1, 2028
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  2. Enrollment target: 782 to 776 Eligibility criteria expanded, about 3 wordsv4 Show 1 more changeShow less
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 1, 2022 to Oct 1, 2022 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Jun 1, 2022 to Oct 1, 2022
    • Site details revised
  4. Start date: Jan 1, 2022 to Jun 1, 2022 Primary completion date: Jan 1, 2025 to Jun 1, 2025 · Completion date: Jan 1, 2026 to Jun 1, 2026v2 Show 2 more changesShow less
    • Primary completion date: Jan 1, 2025 to Jun 1, 2025
    • Completion date: Jan 1, 2026 to Jun 1, 2026
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Rationale: Pump failure due to acute myocardial infarction (AMI) can lead to cardiogenic shock (CS): a state of low blood flow to end-organs with subsequent multi-organ failure that is associated with high mortality rated. The first line pharmacologic treatment strategy in CS is noradrenaline. This vasopressor drug is used to maintain adequate blood pressures. The assumption is that a mean arterial blood pressure (MAP) ≥ 65 mmHg will improve flow and thereby tissue perfusion of myocardium and other tissues (e.g. renal). However, there is no evidence that an increase in MAP, if achieved by noradrenaline, leads to greater end-organ blood flow and better outcomes. Objective: With this study the investigators aim to investigate the (cost-)effectiveness of reduced noradrenaline in patients with CS by using a lower MAP target of ≥ 55 mmHg, compared to ≥ 65 mmHg. The investigators hypothesize that reduced use of noradrenaline will improve overall survival and decrease renal failure requiring renal replacement therapy. Study design: Open label, randomized controlled multicenter trial Study population: Adults patients with CS due to AMI Intervention: Treatment strategy of reduced noradrenaline, by using a lower MAP target ( ≥ 55 mmHg). Main study endpoint: composite of all-cause mortality and severe renal failure leading to renal replacement therapy within 30-days after randomization.
Trial Details
NCT Number NCT05168462
Lead Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions Cardiogenic Shock, Myocardial Infarction
Enrollment 776 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov