NCT05642273Completed
The Effects of oXiris in Cardiogenic Shock Requiring VA-ECMO
The Effects of extraCorporeal bLood Purification (oXiris ®) in patiEnts With cArdiogeNic Shock Requiring VA-ECMO: A Prospective, Open-label, Randomized Controlled Pilot Study
Source: ClinicalTrials.gov · Last updated 29 Mar 2024
Brief summary (registry, in English)
Cardiogenic shock (CS) defines a state of systemic hypo-perfusion leading to end-organ dysfunction related to cardiac pump failure and with mortality rates in the range of 27-50% according to recent reviews. Patients with CS often received mechanical circulatory support, and venoarterial extracorporeal membrane oxygenator (V-A ECMO) is an effective tool to support refractory CS while ensuring continuous organ perfusion. Patients with CS present clinical signs of systemic inflammation and elevated plasma levels of prototypical inflammatory and vasoactive mediators, including C-reactive protein (CRP), Interleukin-6 (IL-6) and tumor necrosis factor alpha (TNFα). As data is scarce in this field, we decided to perform a prospective randomized controlled pilot study to investigate the efficacy of extracorporeal cytokine and lipopolysaccharide adsorption using Oxiris on humoral inflammation parameters, hemodynamics, and clinical outcomes in patients with CS requiring VA ECMO.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 28 Nov 2022
- Start date
- 25 Nov 2022
- Primary completion date
- 8 Jan 2024
- Lead sponsor
- Samsung Medical Center
- NCT number
- NCT05642273
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 25 Nov 2022 to the primary completion date, 8 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Other causes except for CS: septic shock, cardiac arrest by serious ventricular arrhythmia mot related to the myocardial ischemia or heart failure.
- Shock with unwitnessed cardiac arrest outside the hospital
- Severe non-cardiac morbidity with expected survival less than 6 months (malignancy, respiratory failure)
- Heparin allergy
Other
- Suspicious of brain death
- Those who refused active treatment
- Body weight under 30 kg
- Pregnancy
Who the study is looking for
- Patients with more than 18 years old
- CS is defined as the presence of the following:
- 2-1) Systolic blood pressure is less than 90 mmHg for more than 30 minutes despite the fluid therapy, or the use of pressure boosting agents to maintain the systolic blood pressure more than 90 mmHg.
- 2-2) Peripheral hypoperfusion (cold skin, urine less than 30 cc per hour, impaired consciousness, lactate ≥2.0 mmol/l) or a person with pulmonary edema.
- 2-3) Causes of CS include ischemic (acute myocardial infarction or ischemic cardiomyopathy, shock during percutaneous coronary intervention), myocardial (end-stage heart failure, myocarditis), post-cardiotomy shock, cardiac tamponade, or pulmonary thromboembolism.
- Patients receiving VA ECMO owing related to the causes listed in 2-1, 2-2, 2-3.
- Written informed consent from patient or legal surrogates
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.