Amsterdam UMC, location AMC
Amsterdam, 1105AZ, Netherlands
Location status: Recruiting
NCT Number: NCT05168462
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Amsterdam, 1105AZ, Netherlands
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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:
III. Clinical signs of pulmonary congestion
Exclusion criteria
Reduced noradrenaline by using a lower MAP target
Time frame: 30-days
Composite of all-cause mortality and severe renal failure leading to renal replacement therapy
Time frame: The first 24 hours
Blood pressure measured hourly during the first 24 hours of ICU/CCU admission
Time frame: The first 24 hours
Heart rate, measured hourly during the first 24 hours of ICU/CCU admission
Time frame: 0, 6, 12, 24, 36 and 72 hours
Size of myocardial infarction, measured by hs-Troponin T
Time frame: 0, 6, 12, 24, 36 and 72 hours
Size of myocardial infarction, measured by CK-MB
Time frame: Recorded after ICU/CCU discharge, assessed up to 60 days
Type of mechanical circulatory support device
Time frame: Recorded after ICU/CCU discharge, assessed up to 60 days
Duration of mechanical ventilation, expressed in days
Time frame: Recorded after ICU/CCU discharge, assessed up to 60 days
The type of vasopressors / inotropes that were administrered
Time frame: 72 hours and 1 year
As measured by echocardiography and/or MRI
Time frame: 1 year
Renal function, measured by serum creatinin
Time frame: 1-year
Cost per patients alive without severe renal failure and costs per QALY (quality-adjusted life year)
Contact information is provided by the study sponsor or research team.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Other
Acronym: NORSHOCK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06955936
Cardiogenic Shock, Cardiovascular Diseases
Tomsk, Russia
View Trial DetailsNCT00324766
Cardiogenic Shock, Cardiovascular Diseases
Oslo, Norway
View Trial DetailsNCT00469248
Cardiogenic Shock, Cardiovascular Diseases
Halle, Saxony-Anhalt, Germany
View Trial DetailsNCT07643610
Acute Decompensated Heart Failure, Cardiogenic Shock
Basel, Canton of Basel-City, Switzerland
View Trial Details