Идёт набор NCT07402018

Intra-aortic Balloon Counterpulsation (IABC) Compliance

— Наблюдательное Cardiogenic Shock IABC Procedure Intraaortic Balloon Counterpulsation (IABC)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Cardiogenic Shock, IABC Procedure, Intraaortic Balloon Counterpulsation (IABC). Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Arterial Compliance as a Predictor of Clinical Outcomes With Intra-aortic Balloon Counterpulsation: A Prospective Observational Pilot Study

Обзор

The investigators intend to study how baseline arterial compliance (as defined by stroke volume/pulse pressure) influences the clinical success of intraaortic balloon counterpulsation (IABC) in patients with cardiogenic shock (CS). The investigators aim to compare clinical outcomes in CS patients requiring IABC with normal compliance versus low compliance. The study will enroll patients undergoing IABC that are clinically indicated. Baseline hemodynamic measurements will be obtained and then patients would be stratified based on their compliance. Post IABC, serial hemodynamic measurements will be obtained and compared between groups. Patients will continue to be followed longitudinally until the IABC has been discontinued for any reason. The proposed study will yield results that will aid in developing a larger clinical trial and ultimately assist clinicians in determining if IABC is appropriate therapy for patients in cardiogenic shock.

Подробное описание

This study will focus on patients in cardiogenic shock (CS) that will be undergoing clinically indicated intraaortic balloon counterpulsation (IABC) insertion and right heart catheterization. Prior to IABC insertion a patient will have their clinically indicated right heart catheterization. The investigators will record these baseline hemodynamic parameters, including (but not limited to) stroke volume and arterial pulse pressure.

After IABC insertion is completed, repeat hemodynamic measurements will be obtained approximately 30 minutes later. Repeat hemodynamic measurements will be recorded at approximately 3-6 hours following the procedure, and 24 hours following the procedure. The act of recording hemodynamic measurements is part of the usual clinical management of patients with IABC.

The patients will continue be followed longitudinally until their IABC course has completed, either due to resolution of CS, exchange for a separate device, heart transplantation, durable Left Ventricular Assist Device (LVAD) implant, or patient death.

The investigators hypothesize that patients with low arterial compliance will have greater improvements in cardiac output and cardiac filling pressures compared to patients with normal compliance. The specific aims are to (1) compare hemodynamic changes with IABC in cardiogenic shock patients with low compliance vs those with normal compliance and (2) to determine a cutoff value of compliance that can be used for future larger clinical trials.

The proposed study will yield results that will aid in developing a larger clinical trial and ultimately assist clinicians in determining if IABC is appropriate therapy for patients in cardiogenic shock.

Первичные конечные точки

Cardiac Output (L/min) [Срок оценки: 24 hours]

Вторичные конечные точки (12)

Systolic Blood Pressure (mmHg) [Срок оценки: 30 minutes]
Pulmonary Artery Oxygen Saturation (%) [Срок оценки: 24 hours]
Ultimate Disposition [Срок оценки: Longitudinal Follow-Up (approximately 3 months)]
Total Bilirubin (mg/dL) [Срок оценки: 24 hours]
ALT (U/L) [Срок оценки: 24 hours]
AST (U/L) [Срок оценки: 24 hours]
Creatine Clearance/GFR [Срок оценки: 24 hours]
Creatine (mg/dL) [Срок оценки: 24 hours]
Lactate millimoles per liter (mmol/L) [Срок оценки: 24 hours]
Pulmonary Artery Compliance (mmHg) [Срок оценки: 24 hours]
Right Ventricular Stroke Work Index (g·m-²·beat-¹) [Срок оценки: 24 hours]
Pulmonary Artery Pulsatility Index (PAPi) [Срок оценки: 24 hours]

Критерии участия

Критерии включения

Age ≥18 years old
Cardiogenic shock
Undergoing Intra-aortic Balloon Counterpulsation (IABC) as part of clinical care
Able to provide consent or have power of attorney or next of kin provide consent