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

Who is this study for? Patients with Cardiogenic Shock, Myocardial Infarction
What treatments are being studied? Reduced Noradrenaline Use
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Acute myocardial infarction, STEMI or NSTEMI

• Early revascularization by PCI

• Cardiogenic shock, characterized by:

⁃ I. a. Systolic blood pressure (SBP) ≤ 90 mmHg for \> 30 minutes, OR b. Use of drugs to maintain SBP \> 90 mmHg at randomization.

⁃ II. Clinical signs of impaired organ perfusion with at least one of the following criteria:

• Altered mental status

• Cold, clammy skin and extremities

• Oliguria with urine output \< 30ml/hour

• Serum lactate \> 2.0 mmol/L

⁃ III. Clinical signs of pulmonary congestion

Locations
Other Locations
Netherlands
Amsterdam UMC, location AMC
RECRUITING
Amsterdam
Contact Information
Primary
Elma Peters
e.j.peters@amsterdamumc.nl
0205668380
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 776
Treatments
Experimental: Reduced noradrenaline (MAP ≥ 55 mmHg)
No_intervention: Usual care (MAP ≥ 65 mmHg)
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov