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Shock, Cardiogenic clinical trials

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NCT ID: NCT06369818 Not yet 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: April 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: 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: NCT06080074 Not yet recruiting - Heart Failure Clinical Trials

Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System

Start date: July 1, 2024
Phase:
Study type: Observational

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)

NCT ID: NCT05975021 Not yet recruiting - Cardiogenic Shock Clinical Trials

A Safety and Efficacy Trial of Istaroxime for Cardiogenic Shock Stage C

SEISMiC-C
Start date: December 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

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.

NCT ID: NCT05879276 Not yet recruiting - Cardiogenic Shock Clinical Trials

Effect at 3 Months of Early Empagliflozin Initiation in Cardiogenic Shock Patients on Mortality, Rehospitalization, Left Ventricular Ejection Fraction and Renal Function.

EMPASHOCK
Start date: October 2023
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT05838937 Not yet recruiting - Cardiogenic Shock Clinical Trials

The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients

MIX-ECMO
Start date: June 1, 2024
Phase:
Study type: Observational [Patient Registry]

Investigation of the potential prognostic role of non-invasive myocardial work in patients receiving veno-arterial extracorporeal membrane oxygenation therapy.

NCT ID: NCT05782491 Not yet recruiting - Cardiogenic Shock Clinical Trials

Awake Axillary Impella 5.5 Placement - A Feasibility Trial

Start date: April 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05750576 Not yet recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Impact of ECMO Cannula Chlorhexidine-impregnated Dressings to Decrease Extracorporeal Membrane Oxygenation-cannula Related Infection Rate

DRESSING-ECMO
Start date: February 2023
Phase: N/A
Study type: Interventional

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

NCT ID: NCT05748860 Not yet recruiting - Cardiogenic Shock Clinical Trials

PRecision Ecmo in CardIogenic Shock Evaluation

PRECISE
Start date: April 3, 2023
Phase:
Study type: Observational

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.