Clinical Research Directory

Transorbital Ultrasound and Other Markers for Prognosis Prediction After Cardiac Arrest

In sudden cardiac arrest patients with return of spontaneous circulation, brain damage is one of the main determinants of short-term mortality and poor prognosis (CPC 3-5). It is important to properly select group of patients in whom treatment is futile. According to current guidelines, multimodal approach is recommended. Optic nerve sheath diameter measured by ultrasound is non-invasive, fast, low-cost and readily available bed-side method, but evidence for its use as neuroprognostication modality is limited to only few small studies. The aim of this study is to evaluate validity of ONSD as neuroprognostication method at larger cohort of patients, compare it with other established methods and compare ultrasound and CT measurement of ONSD.

Post-CA Neuroprotection With Magnesium

The purpose of this pilot interventional study is to collect preliminary data on administering magnesium sulfate as a neuroprotective medication in patients who achieved Return of Spontaneous Circulation (ROSC) following Cardiac Arrest (CA). The primary aims are to assess the feasibility and safety of administering magnesium and measure serum markers of neuronal injury at prespecified time points in the post-cardiac arrest period. Because this is a pilot study with a limited sample size, the primary objective is to evaluate the precision and stability of the collected measures to inform the design and formal analysis in a larger trial.

AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)

WILLEM is a multi-center, prospective and retrospective cohort study. The study will assess the performance of a cloud-based and AI-powered ECG analysis platform, named Willem™, developed to detect arrhythmias and other abnormal cardiac patterns. The main questions it aims to answer are: 1. A new AI-powered ECG analysis platform can automatice the classification and prediction of cardiac arrhythmic episodes at a cardiologist level. 2. This AI-powered ECG analysis can delay or even avoid harmful therapies and severe cardiac adverse events such as sudden death. The prerequisites for inclusion of patients will be the availability of at least one ECG record in raw data, along with patient clinical data and evolution data after more than 1-year follow-up. Cardiac electrical signals from multiple medical devices will be collected by cardiology experts after obtaining the informed consent. Every cardiac electrical signal from every subject will be reviewed by a board-certified cardiologist to label the arrhythmias and patterns recorded in those tracings. In order to obtain tracings of relevant information, \>95% of the subjects enrolled will have rhythm disorders or abnormal ECG's patterns at the time of enrollment.

Study of the Occurrence of Cardiocirculatory Arrest as a Function of the Level of Hypoxemia During a Maastricht 3 Procedure

Evaluation of the level of hypoxemia during the occurrence of cardiocirculatory arrest during a Maastricht III organ donation procedure.

intErnet-based iNterventions FOR Cardiac arrEst suRvivors

This randomized clinical trial will test whether an internet-based lifestyle intervention administered through a web app can foster Health Related Quality of Life in patients who survived an out-of-hospital cardiac arrest and suffer from these symptoms

Plasma Biomarkers and Platelet Morphology of Extracorporeal CardioPulmonary Resuscitation

Extracorporeal cardiopulmonary resuscitation (ECPR) constitutes a pivotal emergency intervention for cardiac arrest (CA) patients. However, current eligibility criteria and prognostic assessment metrics remain substantially limited, relying predominantly on clinical symptoms and physical signs while lacking objective biomarker data. Integrating reproducible, highly sensitive, and specific proteinaceous and metabolic indicators with ultrastructural platelet alterations may hold significant implications for both ECPR administration and prognostication in CA. Therefore, the purpose of this study is to identify the plasma proteomic and metabolomic characteristics of patients with refractory cardiac arrest before and after ECPR treatment, as well as the characteristics of platelet morphological and structural changes, to search for potential specific markers that can predict CA patients who may benefit from ECPR so as to optimize treatment selection.

Optimizing Ventilation to Improve Survival From Out-of-hospital Cardiac Arrest: the OPTIVO Randomized Controlled Trial

When the heart stops pumping during cardiac arrest, cardiopulmonary resuscitation (CPR) is used to continue pushing blood and providing oxygen to vital organs. CPR involves a combination of chest compressions (to push the blood) and ventilations (to provide oxygen and gas exchange). There is a lot of research that has helped to optimize the provision of chest compressions, however there is considerably less research available to guide ventilations. The current guideline recommendations are based on limited data, and no data that is specific to cardiac arrest patients. There is a recognized need for research to better guide ventilation during CPR. This research will help to better define appropriate ventilation targets for cardiac arrest patients.

Emergency Resuscitative Endovascular Balloon Occlusion of the Aorta in Out of Hospital Cardiac Arrest

This study will assess the feasibility of performing pre-hospital resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct to conventional Advanced Life Support (ALS) in patients suffering from non-traumatic out of hospital cardiac arrest (OHCA). As well as providing valuable insights into the technical feasibility of performing this procedure as part of a resuscitation attempt, the study will also document the beneficial physiological effects of REBOA in this group of patients.

In-hospital Cardiopulmonary Resuscitation With Balloon Occlusion of the Descending Aorta

This study will test if a sustained Return of Spontaneous Circulation (ROSC) in patients with cardiac arrest is more frequent when patients receive advanced cardiac life support (ACLS) alone or when they receive ACLS plus a balloon occlusion of the thoracic aorta.

Bicarbonate for In-Hospital Cardiac Arrest

This is an investigator-initiated, multicenter, randomized, placebo-controlled, parallel group, double-blind, superiority trial of sodium bicarbonate during adult in-hospital cardiac arrest. There will be 22 enrolling sites in Denmark. 778 adult patients with in-hospital cardiac arrest receiving at least one dose of adrenaline will be enrolled. The primary outcome is return of spontaneous circulation and key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.

Targeted Temperature Management at 33°C Versus Controlled Normothermia for In-hospital Cardiac Arrest

The IH-TTM trial is designed to determine whether survival with a favorable neurological outcome is improved by induced hypothermia at 33°C in comatose critically ill patients admitted after resuscitated in-hospital cardiac arrest (IHCA). Recent evidence suggests that targeted temperature management (TTM) at 33°C may provide no survival benefits compared to controlled normothermia in unselected patients with out-of-hospital cardiac arrest (OHCA). However, this evidence is relevant only to OHCA of presumed cardiac origin, chiefly witnessed and immediately followed by resuscitation efforts. Only scant data are available for cardiac arrest (CA) of other origins and for IHCA. In a randomized clinical trial of patients with CA in an initial non-shockable rhythm, the subgroup with IHCA had significantly better outcomes when treated with TTM at 33°C versus controlled normothermia; nevertheless, the sample size was limited. Another randomized controlled trial done specifically in patients with IHCA failed to show benefits of TTM at 33°C compared to controlled normothermia but was underpowered. Thus, whether therapeutic hypothermia is indicated after IHCA remains unclear. IH-TTM will be the largest trial assessing TTM after IHCA.

Serious Game for Improving Targeted Temperature Management Knowledge and Situational Awareness in Critical Care Nurses

This randomized controlled trial aims to evaluate the effectiveness of a serious game in improving targeted temperature management (TTM) knowledge and situational awareness among critical care nurses. A total of 120 nurses from adult intensive care units will be randomly assigned to either a control group receiving traditional lecture-based teaching or an experimental group receiving lecture-based teaching combined with a digital serious game. Outcomes will be measured using a TTM knowledge test, a situational awareness scale, and a system usability scale. The findings will provide evidence for the use of serious games as an innovative educational strategy to enhance post-resuscitation care quality and patient safety.

Predictors for Survival and Good Neurological Outcome in E-CPR and Non CPR Treated Patients

In ECPR, where CPR times often range from 30 to 120 minutes, only patients with good circulation during CPR survive, while non-survivors commonly suffer from anoxic brain injury. The selection process during CPR is challenging causing a general survival rate of just 2 out of 10, and the urgent need for better selection criteria has been emphasized. It it crucial to keep cardiac arrest times as short as possible, pre primed-ECMO can facilitate this. The ECMO treatment and the long CPR times of ECPR can also affect the measurements of the neurologic prognostication guidelines after cardiac arrest, making its validity uncertain in this specific cohort. Further, the long-term neuropsychological follow-up is limited to a few patients, making it uncertain if ECPR gives the survivors good long-term life satisfaction or just a prolonged life. Our overall aim is to optimize and improve the care pathway for ECPR patients by refining patient selection, assessing pre-primed ECMO, validating neurological prognostication guidelines, and understanding long-term outcomes and challenges faced by survivors. Specific Aim 1: Evaluating predictors for good neurological outcomes in ECPR and to develop and validate (internally and externally) an evidence-based selection tool for ECPR. Specific aim 2: To assess the sterility and function of pre-primed ECMO. Specific aim 3: To evaluate the applicability of current guidelines for neurological prognostication after cardiac arrest in ECPR patients, and to assess the predictive value of individual and combined neurological tests in this specific patient population. Specific aim 4: To determine the long-term neuropsychological outcomes, identify the problems survivors experience in daily life, and assess life satisfaction - by comprehensive follow-up visits with validated questionnaires and neuropsychology testing up to 12 years after the ECMO-treated cardiac arrest.

Resuscitative TEE Collaborative Registry

The general objective of this study is to evaluate the clinical impact and safety of focused, point-of-care transesophageal echocardiography (TEE) used during the evaluation of critically-ill patients in the emergency and intensive care settings. The target population for this study are critically-ill patients over the age of 18 who as part of their routine clinical care are receiving a focused TEE. The primary objective of this study is to determine the clinical impact and safety of TEE performed during the evaluation of critically-ill patients in the emergency department and intensive care settings. The secondary objective(s) of this study are to characterize the use of this imaging modality in the subsets of critically-ill patients in shock and cardiac arrest; including but not limited to; description of the frequency of studies, clinical indications, clinician characteristics, echocardiography findings, timing of studies, procedure-related complications and patient outcomes.

Continuous Jugular Venous Oxygen Saturation (SjO2) Measurement After Cardiac Arrest

Patients successfully resuscitated from sudden cardiac arrest are often comatose, having suffered a period of low blood flow and oxygen delivery to the brain. They are also at risk of suffering further brain injury during the immediate period after resuscitation, in which the brain's normal regulatory functions are impaired. To diagnose and treat secondary brain injury in comatose patients after cardiac arrest, doctors use a variety of neurological monitoring techniques. One of these methods involves measuring the oxygen saturation of blood going into and out of the brain to determine whether the brain is receiving and utilizing oxygen in an optimal manner. The oxygen saturation of blood exiting the brain is called the jugular venous oxygen saturation (SjO2). It is measured by inserting a catheter into the jugular vein in the neck and sampling blood as it exits the skull. The blood sample is sent to the hospital laboratory and the oxygen saturation is measured on a blood gas machine. This method of SjO2 measurement has limitations, particularly that blood must be taken out of the patient and sent to the lab for analysis, which can only be done feasibly every few hours. Special catheters exist that can measure the oxygen saturation of blood passing by the tip of the catheter inside the patient on a second-by-second basis, without needing to withdraw blood and send it to the laboratory. With such rapidly available data, doctors may be able to better diagnose and treat brain oxygen abnormalities in post cardiac arrest patients. In this study, the investigators plan to determine the accuracy of an existing, Food and Drug Administration (FDA)-cleared catheter capable of continuous, indwelling measurement of venous blood oxygen saturation for SjO2 monitoring in comatose patients early after cardiac arrest. The SjO2 measurements from the study catheter will be compared with standard SjO2 measurements made by withdrawing blood and analyzing it in the laboratory to determine if the new catheter is accurate. The investigators will also collect blood samples using the study catheter to measure levels of specific proteins that indicate damage to brain tissue. The study will enroll 25 participants admitted to the intensive care unit at one hospital cared for by a group of doctors that specialize in the neurological care of patients after cardiac arrest. The investigators hypothesize that the study catheter will accurately measure SjO2 compared to the standard laboratory method.

Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock.

Among patients admitted after an out-of-hospital cardiac arrest (OHCA) in intensive care unit (ICU), almost two thirds of patients will develop in the first hours a post-cardiac arrest (CA) shock. This post-CA shock, combines cardiac and hemodynamic failure, generally resulting in multi-organ failure and early death in up to 35% of patients. Experimental data suggest that intravenous ascorbic acid (vitamin C) may attenuate inflammation and vascular injury related to sepsis or surgery. Preclinical and clinical studies also provide safety data of high dose intravenous vitamin C (\> 200mg/kg/day) with no significant adverse event reported and favorable impact on outcome. Experimental data also suggest beneficial effect of vitamin C in post-CA management with improvement of shock and multi-organ failure with potential benefit on neuroprotection and outcome. The study is a phase II multicenter prospective controlled open-label trial randomized in two parallel groups : * Expérimental group: Standard of care care for post-CA shock + Vitamin C (Vit-C) 200mg/kg/d IV (started as early as possible, no later than 1 h after randomization + thiamin (Vit B1) 200mg every 12 h during 3 days. * Control group: Standard of care care for post CA shock according international guidelines. Patient number to be enrolled : 234, Study duration :24 months and 28 days, Inclusion duration : 24 months, Patient participation : duration : 28 days

Neuroprognostication Bias: A Collaboration to Reduce the Impact of Self-fulfilling Prophecy in Cardiac ARrEst

Cardiovascular disease remains the leading cause of death in the United States. Mortality rates of cardiac arrest range from 60-85%, and approximately 80% of survivors are initially comatose. Of those who survive, 50% are left with a permanent neurological disability, and only 10% are able to resume their former lifestyle. Early prognosis of comatose patients after cardiac arrest is critical for management of these patients, yet predicting outcome for these patients remains quite challenging. The primary study objective of SPARE is to assess the value of using a systematic, multi-modal approach for neuroprognostication in the unconscious post-cardiac arrest population. We hypothesize that prognostication using this approach will be significantly improved compared to historical controls. This approach will be novel because: All patients who are unconscious at least 24 hours post-cardiac arrest, whereas previous studies on neurologic outcome tended to have restrictive inclusion criteria, such as no pre-existing neurologic impairment (e.g. dementia or prior cerebrovascular injury), or included an unduly restrictive population, such as patients with a strictly comatose state. The prognostic modalities used to assess patients will be applied at specific time points that will maximize their utility. Patients' families and clinicians will be encouraged to provide adequate time to allow for a delayed recovery, especially in cases of uncertain outcome, thus minimizing the self-fulfilling prophesy bias of early withdrawal of life-sustaining therapies (WLST). This will be particularly pertinent in the comparison of US and Brazil/Italy patients, as the Brazilian and Italian populations are not commonly exposed to premature WLST (as can be the case in the US), one of the major sources of biases in prognostication studies of cardiac arrest due to the self-fulfilling prophecy.

Early Amiodarone in Shockable Cardiac Arrest

The primary objective of this pilot, pragmatic stepped-wedge cluster randomized trial is to evaluate if a modified cardiac arrest treatment algorithm calling for the administration of the initial amiodarone dose one 2-minute cycle earlier than current guidelines (during the same cycle as the initial dose of epinephrine) improves the time to amiodarone delivery in those with out-of-hospital cardiac arrest due to refractory ventricular fibrillation or ventricular tachycardia compared to usual care.

Rehabilitation for Survivors of Out-of-hospital Cardiac Arrest

This study is a parallel group multicentre investigator-initiated clinical randomised controlled superiority trial that will include a total of 214 survivors of OHCA. Participants will to be randomized with a 1:1 allocation ratio to either a intervention consisting of a comprehensive initiated tailored rehabilitation intervention focusing on supporting RTW plus usual care compared to usual care alone.

Respiratory Parameters Using Advanced Airways During In-hospital Cardiac Arrest

The investigators aim to investigate the real life volumes of air delivered to the lungs when rescuers deliver these breaths by hand as part of resuscitation attempts during cardiac arrest. The study will compare the volumes achieved using different devices which are routinely used to provided an airway during routine cardiac arrest care. Volumes will be measured using a small non intrusive device which sits in the airway circuit and measures flow of air in real time. The patients chosen for this study will be those already recruited to an ongoing trial (AIRWAYS-3) assessing the outcomes for patients suffering in hospital cardiac arrest based on airway device used.

Hospital Airway Resuscitation Trial

The Hospital Airway Resuscitation Trial (HART) is a cluster-randomized, pragmatic trial of advanced airway management with a strategy of first choice supraglottic airway vs. first choice endotracheal intubation during in-hospital cardiac arrest.

The Effect of Prehospital Combination of Epinephrine, Vasopressin, and Steroid in OHCA

This project is a randomized controlled clinical research design, The hypothesis P-I-C-O of the study is: For adult patients in the Taipei City and New Taipei City communities who have suffered sudden non-traumatic death and have been resuscitated by advanced paramedics, the intervention group that receives combined drug treatment (epinephrine, vasopressin, methylprednisolone) has a better rate of sustained recovery of spontaneous circulation (ROSC) (primary outcome) and long-term survival status (secondary outcomes) compared to the control group that receives single drug treatment (epinephrine).

The Impact of Frailty on Cardiopulmonary Resuscitation Adverse Outcomes in Patients Requiring Code Blue Activation

The aim of this study was to determine the independent association of frailty with cardiopulmonary resuscitation and predictive factors in patients triggering code blue response

Neuroprotection Bundles For Comatose Survivors Following Cardiac Arrest

The investigators designed LAPTOPS to determine the effectiveness of a goal-directed neuroprotection bundles of active management including body temperature,PaCO2,PaO2,position,Blood glucose ,blood sodium,Blood pressure and Lactate vs. usual care in adult post-cardiac arrest care. LAPTOPS is a large-scale pragmatic clinical trial to provide reliable evidence over the effectiveness of a widely applicable goal-directed care bundle in acute phase of adult post-cardiac arrest care.