View clinical trials related to Shock, Cardiogenic.
Filter by:The goal of this randomized controlled trial is to appraise the impact of intra-aortic balloon pump (IABP) in the treatment of early stages of cardiogenic shock, irrespective of etiology. Findings of this randomized trial may enhance clinical decision making regarding the use of MCS in specific subsets of patients in early stages of cardiogenic shock. The main questions it aims to answer are: - What are the effects of IABP on a composite of clinical endpoints representing clinical deterioration at 30-days in patients presenting with SCAI stage B or C cardiogenic shock? - What is the 1-year clinical outcome (including mortality and hospital admissions for cardiovascular causes) of patients treated with vs. without IABP for early cardiogenic shock? - Is there a difference in efficacy of IABP within the treatment of early cardiogenic shock related to Acute Coronary Syndrome versus non-ischemic causes? - Is there a difference in efficacy of IABP within the treatment of SCAI stage B versus stage C cardiogenic shock? Participants will be 1:1 randomized to IABP support or standard of care (a treatment strategy including inotropes and/or vasopressors but no IABP insertion). Patients will be stratified for Acute Coronary Syndrome/non-ischemic etiology and stage B/stage C cardiogenic shock, following stratification to center. Researchers will compare the group who was randomized to IABP to the control group (i.e. standard of care) to see if there is a difference in the primary trial endpoint after 30-days, including 1) all-cause mortality, 2) escalation to invasive mechanical ventilation, 3) escalation of mechanical circulatory support strategy, 4) acute kidney injury and 5) stroke or transient ischemic attack.
The use of antibiotic therapy is common in intensive care units and primarily involves beta-lactams. Its optimal implementation is made difficult by the pharmacokinetic changes inherent in critically ill patients. Despite the current recommendations from the French Society of Anesthesiology and Intensive Care (SFAR) and the French Society of Pharmacology and Therapeutics (SFPT), there are no recommendations on prescription modalities for patients under veno-arterial extracorporeal membrane oxygenation (VA-ECMO). The use of antibiotic therapy is common in VA-ECMO patients and their pharmacokinetic variability factors are then exacerbated. We aim to conduct a prospective, multicenter, interventional study designed to identify predictive factors for failure to achieve therapeutic target circulating concentrations of beta-lactams in patients under VA-ECMO treated with one of the studied beta-lactams
Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition
The goal of this multicenter observational clinical trial is to evaluate the safety and effectiveness of the Cardiohelp System for VA-ECMO in children with cardiac failure. The main question[s] it aims to answer are: - What is the safety and effectiveness of the Cardiohelp device for pediatric ECMO? - What are the optimal performance specifications of the Cardiohelp device in children? Should the Cardiohelp device be FDA-cleared for children? Children who are receiving the Cardiohelp device will be approached and consented to participate if interested. Participants will undergo a standardized data collection to estimate survival to 30 days and the prevalence of serious adverse events like stroke, bleeding, and hemolysis. Outcomes will be compared to performance goals (PG) derived from the ECMO literature. Funding Source -- FDA OOPD (Office of Orphan Product Development)
The current trial aims to assess the effect of istaroxime in patients with SCAI Stage C Cardiogenic Shock (CS). These patients look unwell, frequently with a sudden change in mental status, mottled and cool extremities, and delayed capillary refill, as well as signs of congestion and relative low blood pressure and signs of hypoperfusion (reduced oxygen to organs) which frequently require support with rescue therapies including inotropes, vasopressors, or mechanical devices. Windtree Therapeutics, Inc. has been studying istaroxime, which has the potential to treat patients in this condition without some of the disadvantages of existing therapies being used to treat patients with acute heart failure and CS. Participants enrolled in this trial will receive standard of care (SoC) therapy for heart failure and CS. Additionally, half of the participants will be randomly chosen to receive istaroxime. Istaroxime has the potential to increase blood pressure and improve cardiac function.
Long term prognosis of cardiogenic shock is related to the resolution of haemodynamic failure, associated visceral failure and the recovery of an adequate myocardial function. In the immediate aftermath of cardiogenic shock, after catecholamines weaning, there are no recommendations on cardiovascular treatments that would improve this long term prognosis. Indeed, the standard cardiovascular treatments such as inhibitors of the renin-angiotensin and aldosterone system and beta-blockers have hypotensive and negative inotropic effects and may worsen the renal function. In practice, given their side effects, they are not prescribed in the immediate aftermath of cardiogenic shock. Sodium-glucose co-transporter 2 (iSGLT2) inhibitors are now an integral part of the drug management of chronic heart failure and the EMPULSE-HF trial has just demonstrated a benefit in acute heart failure (PMID: 35228754). Several pivotal clinical trials have demonstrated a significant effect of iSGLT2 on the survival and the risk of re hospitalisation for heart failure (PMID: 32865377, 31535829, 33200892). Our hypothesis is that, in patients in cardiogenic shock, early treatment with Empaglifozin in addition to the standard management could reduce mortality and morbidity (death, transplantation/LVAD and rehospitalisation for heart failure) and improve myocardial function at 12 weeks, compared with standard management alone.
Investigation of the potential prognostic role of non-invasive myocardial work in patients receiving veno-arterial extracorporeal membrane oxygenation therapy.
The Abiomed Impella 5.5 is a surgically placed temporary mechanical support device used in patients in cardiogenic shock. The investigators propose using regional anesthesia (3 separate peripheral nerve blocks) to facilitate Impella 5.5 placement, a procedure which has traditionally been performed under a general anesthetic. Regional anesthesia is a proven and widely used technique to facilitate upper extremity vascular surgery cases (i.e. arteriovenous fistula creation). The investigators believe that employing these blocks in conjunction with intravenous sedation or monitored anesthesia care (MAC anesthesia) - a technique used in all types of cases, even in sick hearts during thranscatheter aortic valve replacements (TAVR) - will avoid the need increased doses of medications to support the blood pressure and cardiac output, avoid the need for post operative mechanical ventilation and intravenous sedation, and speed up the time to participating in physical therapy, time to heart transplant/durable mechanical support/recovery, and time to hospital discharge.
The Dressing-ECMO trial is a prospective, open-label, multicenter, controlled trial randomizing patients who received percutaneous ECMO to cannula chlorhexidine-impregnated dressing vs standard dressing. The study goal is to determine if cannula chlorhexidine-impregnated dressings can reduce the number of cannula major-related infections with or without bloodstream infection
Venoarterial (VA) ECMO is a form of life support for patients with severe cardiogenic shock and cardiac arrest. Although it can be lifesaving, currently many patients still die or have long term disability, such as weakness, shortness of breath and cognitive impairments, and it remains extremely expensive. It is important that new ways of identifying which patients will gain the most benefit from ECMO are found, while also avoiding costly futile use when it there is no benefit. The PRECISE Study is an Australian-led, nation-wide observational study that will investigate whether biomarkers can better guide decisions around to whom and how ECMO is delivered. The study will involve the collection of a small amount of blood (which would normally be discarded) at up to 4 different time points, including just prior to ECMO initiation, and also at days 1, 3, and 7 of ECMO support. These results will then be linked to a national registry which includes the important patient centred outcomes, such as disability at 6 months. This study will lead to the better support of a highly vulnerable population, and improve the efficiency of one of the most complex and costly interventions available.