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Shock, Cardiogenic clinical trials

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NCT ID: NCT06414187 Not yet recruiting - Cardiogenic Shock Clinical Trials

Clinical Effects of Intra-aortic Balloon Support in Early Acute Coronary Syndrome and Non-Acute Coronary Syndrome Related Cardiogenic Shock

IABP ON-TIME
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06376318 Active, not recruiting - Sepsis Clinical Trials

Shock and Acute Conditions OutcOmes Platform

ShockCO-OP
Start date: January 1, 2024
Phase:
Study type: Observational

In-hospital mortality of patients admitted in the intensive care unit (ICU) for circulatory shock remains high (between 20 and 40%). Currently, there are no markers that allow us to classify patients with circulatory shock at higher risk of early and late bad outcomes, or who may better respond to a specific intervention. To understand the contribution of biological heterogeneity to circulatory shock independently from its etiology, the ShockCO-OP Research Program aims to use clustering approaches to re-analyze existing clinical and molecular data from several large European and North American prospective cohorts and clinical trials. This will enable an improvement in risk prediction and a better patient selection in future clinical trials to assess a personalized therapy (i.e., prospective enrollment based on a biological/molecular signature).

NCT ID: NCT06369818 Recruiting - Cardiogenic Shock Clinical Trials

Correlation of Cardiac Output Determined by Echocardiography and Indirect Calorimetry in Critically Ill Patients in Cardiogenic Shock on Extracorporeal Circulatory Life Support

Start date: January 18, 2024
Phase:
Study type: Observational

This observational study investigates whether the daily measured trend of cardiac output as evaluated by indirect calorimetry correlates with the same evaluated by transthoracic echocardiography.

NCT ID: NCT06338345 Not yet recruiting - Cardiac Arrest Clinical Trials

Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA Patients

KAMELOT
Start date: September 1, 2024
Phase: N/A
Study type: Interventional

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

NCT ID: NCT06336655 Recruiting - Cardiogenic Shock Clinical Trials

Physiology of Unloading VA ECMO Trial

Start date: April 15, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to compare the use of veno-arterial extracorporeal membrane oxygenation (VA ECMO) with and without left ventricular (LV) unloading in patients being treated for non-postoperative cardiogenic shock (CS). The main aims of the study are: 1. To determine the physiologic effects on cardiopulmonary congestion of adding LV unloading to VA ECMO 2. To determine the effects on myocardial function of adding LV unloading to ECMO 3. To test the effects on myocardial recovery of adding LV unloading to VA ECMO Participants who are being treated with VA ECMO will be randomized to receive or not receive LV unloading in the form of an intra-aortic balloon pump (IABP). Over the course of the study, the investigators will obtain measurements via lab work, echocardiography, and pulmonary artery catheter that will allow comparison of the two groups.

NCT ID: NCT06330597 Recruiting - Heart Failure Clinical Trials

NIVIA-Hemodynamics

Start date: July 17, 2021
Phase:
Study type: Observational

This is an investigator-initiated, single-center, single-arm prospective study to compare non-invasive hemodynamic assessment using transthoracic echocardiography (TTE) and lung ultrasound (LUS) and hemodynamic assessment using PAC. Patients who have been hemodynamically assessed using PAC will be invited to participate. Each patient will undergo TTE and LUS immediately after first invasive assessment, and again daily after PAC assessments.

NCT ID: NCT06308055 Not yet recruiting - Cardiogenic Shock Clinical Trials

Abiomed Impella RT-DAQ - Observational Study

Start date: April 1, 2024
Phase:
Study type: Observational [Patient Registry]

Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition

NCT ID: NCT06253104 Recruiting - Heart Failure Clinical Trials

Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure

Start date: February 19, 2024
Phase:
Study type: Observational

This study aims to determine, via skeletal muscle ultrasound (US), the extent, timing and relationship between skeletal muscle mass loss and outcomes after orthotropic heart transplantation (OHT) and left ventricular assist device (LVAD) implantation amongst patients with cardiogenic shock. Advanced therapies such as OHT and VADs in the heart failure (HF) population may promote skeletal muscle mass and subsequent quality of life, but there is a lack of literature assessing muscle mass changes in HF patients before and after advanced therapies using US imaging. Therefore this observational study will provide further insight into the 1) changes in lean body mass during critical illness and 2) the feasibility of using bedside US to assess lean body mass in the inpatient setting.

NCT ID: NCT06250439 Recruiting - Cardiogenic Shock Clinical Trials

Effect of Peripheral VA-ECMO Flow Variations on the Pulmonary Arterial Occlusion Pressure (PAPO) in Patients With Refractory Cardiogenic Shock.

PAPO-Flow
Start date: March 7, 2024
Phase: N/A
Study type: Interventional

This study focuses on a population of adult patients placed under peripheral Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO) for refractory cardiogenic shock. Cardiogenic shock, primarily caused by myocardial infarction, is associated with a high mortality rate that remains around 50%, despite advancements in the field of coronary reperfusion. VA-ECMO is a rapidly growing cardiac support technique worldwide. Its goal is to improve peripheral organ perfusion even as myocardial damage continues, thereby enhancing the prognosis of patients with severe multiorgan failure. VA-ECMO is a temporary cardio-respiratory support technique based on the principle of extracorporeal circulation. However, patients under VA-ECMO are at risk of experiencing various complications, including infectious, thromboembolic, hemorrhagic complications, or malfunctions of the ECMO machine itself, with the incidence increasing with the duration of assistance. Numerous authors and scientific reviews highlight the increased risk of Acute Pulmonary Edema (APE) in patients under peripheral VA-ECMO, attributing it to the elevation of afterload induced by retrograde arterial reinfusion against the residual native blood flow, hypothetically leading to an increase in Pulmonary Artery Occlusion Pressure (PAOP). This phenomenon is presumed to intensify as the VA-ECMO reinfusion rate increases. Furthermore, APE under ECMO-VA represents a turning point in the patient's course. Brechot et al. demonstrated that patients who developed APE under VA-ECMO had a prolonged ECMO duration, a higher reliance on mechanical ventilation, an extended stay in critical care, and a higher mortality rate compared to patients who had previously undergone a left ventricular unloading technique (aimed at reducing PAOP and the risk of APE). However, until now, no physiological study has assessed the specific effect of the variation in peripheral VA-ECMO flow on the change in PAOP during a dedicated protocol. It is with the aim of addressing this question that the investigators are considering the PAPO-Flow study.

NCT ID: NCT06162247 Recruiting - Clinical trials for Acute Coronary Syndrome

Naples Federico II Intensive Cardiac Care Unit Registry (Naples FED2-ICCU Registry)

Start date: November 20, 2023
Phase:
Study type: Observational

This protocol proposes to prospectively evaluate current epidemiology, pharmacologic and invasive management and clinical outcomes of patients with acute cardiovascular diseases admitted at our ICCU.