5 Clinical Trials for Various Conditions
The investigators objective is to assess the utility of renal biomarkers in predicting renal recovery following institution of Venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO). Tissue biomarkers of renal injury may provide a real-time indication of renal function and the likelihood of renal recovery in patients having cardiogenic shock and requiring VA-ECMO. In these patients, traditional markers of kidney function (urine output and serum Creatinine level) do not accurately represent renal function.
This study is to test the usefulness of ultrasound dilution measurements in patients on extracorporeal membrane oxygenation. Measurements may include; efficiency of support (recirculation), amount of clotting in the oxygenator (oxygenator blood volume), and how well the heart is working (cardiac output). At the present time there are no devices available to perform these functions.
Acute compartment syndrome (ACS) is a surgical emergency that can develop in patients on extracorporeal membrane oxygenation (ECMO). ACS is a type of limb ischemia, which means that the limb, such as the arm or leg, loses blood flow. Patients on ECMO can develop this condition for many reasons, but most commonly from the ECMO procedure itself. This most commonly involves the leg. Key symptoms of ACS include severe pain, loss of pulses, loss of feeling, and inability to move the limb. However, because patients on ECMO are often sedated, ACS is difficult to diagnose as patients can not report symptoms. As a result, the only available tool for diagnosing ACS may be measurement of pressures in the limb. This is normally done with a needle-device, which is inserted into the leg for a single measurement. However, a recently developed device, called the MY01 Continuous Compartment Pressure Monitor, allows for continuous pressure readings instead of a single measurement. Multiple measurements may allow for much greater accuracy in diagnosing ACS, which may result in faster time to surgery and potentially save more limbs than single measurements. This device may also be less invasive than an older method of continuous pressure measuring, which uses a needle and tubing that is 14-gauge in size. Therefore, this study aims to compare 3 different types of methods for diagnosing ACS in patients on ECMO, which are 1) Standard of Care, 2) Standard of Care and MY01, and 3)Standard of Care and 14-gauge slit catheter.
A Clinical Events Committee (CEC) will include Cardiac Surgery Professor and chief of cardiac surgery Rose Kelly MD, Professor of Medicine Ganesh Raveendran MD at the University of Minnesota who is the direction of Interventional Cardiology and Professor of Medicine at the University of Minnesota David Benditt. They will review and adjudicate serious and unexpected adverse events independently from the PI and co investigators.
There is limited data on the respiratory system mechanics and ideal mode of ventilation for patients on veno-arterial extra-corporeal membrane oxygenation (VA ECMO) post cardiac arrest. In this observational study, the investigators will review and/or obtain laboratory, hemodynamic, respiratory system mechanical, and clinical data from patients on VA ECMO. The specific aims of this study are as follows: Aim 1: To characterize the lung ventilation strategy employed in patients on VA ECMO and its success. Aim 2: To characterize respiratory system mechanics while on ECMO using esophageal manometry and Electrical Impedance Tomography (EIT). Aim 3: To characterize right heart function and pulmonary vascular hemodynamics on the employed ventilation strategy. The overarching hypothesis is that fine-tuned individualized ventilation might be superior to an algorithm that does not account for cardiac and pulmonary functions. Therefore, the aims of this study are to identify areas in which the ventilation strategy may theoretically be suboptimal, which will guide future interventional studies investigating alternatives methods of ventilation which may reduce time on the ventilator after cardiac arrest, time in the intensive care unit, and need for veno-venous ECMO.