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NCT ID: NCT05428423 Recruiting - Sepsis Clinical Trials

Reliability of PVI Changes During Tidal Volume Challenge in ICU Patients

Start date: June 6, 2022
Phase:
Study type: Observational

The aim of this study is to assess whether changes in the plethysmography variability index, during a tidal volume challenge, can reliably detect simultaneous changes in arterial blood pressure pulsatility, in patients hospitalized in intensive care unit. If results will be positive, this will allow the test to be performed even in the absence of an invasive arterial catheter.

NCT ID: NCT05426083 Recruiting - Clinical trials for Acute Coronary Syndrome

Left Ventricular Physiological Effects of Veno-Arterial Extracorporeal Membrane Oxygenation Support During Cardiogenic Shock

Start date: August 4, 2022
Phase:
Study type: Observational

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.

NCT ID: NCT05415332 Recruiting - Cardiogenic Shock Clinical Trials

The Current Status and Clinical OUTcomes of Cardiogenic Shock Patients And the Role of Specialist in Cardiovascular Critical Care Unit

SCOUT SPARC
Start date: June 1, 2020
Phase:
Study type: Observational

In the case of cardiogenic shock, the early mortality rate is the highest compared to other types of shock, but it is characterized by a good prognosis and quality of life after recovery, so monitoring the treatment progress is very important to identify the patient's prognosis. However, there are few studies specifically reported on hemodynamic monitoring and prognosis of cardiogenic shock. In addition, as mechanical circulatory support devices are in the spotlight, studies on their effects and safety are starting, but studies on cardiogenic shock are often limited to patients with myocardial infarction. This study is a prospective and retrospective cohort observational study, we aim to identify factors that can improve prognosis, including various drug treatments, diagnostic techniques, and mechanical circulatory support device by investigating the treatment status and clinical outcomes of patients with cardiogenic shock hospitalized in cardiovascular critical care unit. In addition, the purpose of this study is to investigate the association between the prognosis of patients with cardiogenic shock and the presence of a specialist resident during regular work hours to clarify the role and necessity of a resident specialist in the cardiovascular intensive care unit. Furthermore, by predicting and treating the clinical course of patients with cardiogenic shock at an early stage, the aim is to reduce the mortality rate and improve the patients' ability to perform daily activities.

NCT ID: NCT05402553 Recruiting - Sepsis Clinical Trials

The Efficacy of Adjunctive Use of Ondansetron in Patients With Sepsis and Septic Shock

Start date: April 24, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Sepsis is a systemic inflammatory response that has deleterious effects and considered the leading cause of death in critically ill patients 1 . One of the hallmarks of severe sepsis is the progressive, injurious inflammatory response to infection, mediated by the excessive release of inflammatory mediators and consequently, associated with multiple organs damage 2 . Various studies have demonstrated that adverse outcomes in sepsis patients are closely related to the development of myocardial dysfunction 3 . The mortality of sepsis combined with cardiac functional insufficiency has increased significantly to 70%-90% 4 . Therefore, targeting cardiac insufficiency and heart injury may represent a novel treatment strategy. Several reports documented critical involvement of serotonin 5-hydroxytryptamine in the pathogenesis of sepsis. The aim of the current study is to evaluate the efficacy of ondansetron adjuvant use in patients with sepsis and septic shock.

NCT ID: NCT05383963 Recruiting - Sepsis Clinical Trials

Evaluation of Parameters Collected From Routine Data for the Diagnosis of Sepsis and Septic Shock and Their Influence on Time to Diagnosis and Patient Outcome

Start date: July 15, 2022
Phase:
Study type: Observational

Retrospective observational study to develop a Machine Learning Algorithm to evaluate parameters collected from routine data for the diagnosis of sepsis and septic shock and their influence on time to diagnosis and patient outcome.

NCT ID: NCT05366452 Recruiting - Cardiogenic Shock Clinical Trials

Evaluation of the Efficacy of Early Implantation of a Percutaneous Left Ventricular Assist Devices in Acute Coronary Syndrome Complicated by Cardiogenic Shock Compared to Conventional Therapy: a Prospective, Multicenter, Randomized, Controlled and Open-label Clinical Trial

ULYSS
Start date: December 19, 2022
Phase: N/A
Study type: Interventional

The ULYSS study is a randomized, multicenter, interventional and prospective open-label clinical trial. It aims to evaluate the efficacy of the addition of an early IMPELLA CP support on top of optimal medical therapy and culprit lesion PCI compared to optimal medical care and culprit PCI in patients with an ACS complicated by a CS. A transthoracic echography is required to exclude some non-inclusion criteria as soon as possible and before randomization. Randomization will be performed after an informed consent is signed by the patient, a family member if he is unable to consent or thanks to the emergent consent procedure if all inclusion criteria are met and there are no non-inclusion criteria. A computer-generated randomization list will be drawn-up using a permuted block design (stratified on center). Each center will have a specific list. Randomization 1:1 to one of the 2 groups In all patients, emergent PCI of the culprit lesion will be performed. - Control group: patients will receive IV inotropes associated or not with vasopressors according to the attached protocol and based on the current guidelines (annex 1) (2, 4) in addition to emergent culprit lesion PCI - Experimental group: patients will receive IMPELLA CP before PCI on top of conventional therapy based on the same protocol as the control group and emergent culprit PCI

NCT ID: NCT05357339 Recruiting - Sepsis Clinical Trials

Microcirculation Properties of Albumin for Fluid Resuscitation in Septic Shock

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The sublingual microcirculation is impaired in sepsis and septic shock. Sidestream dark field imaging technology has been developed into a clinical tool to help the clinician assess the microcirculation at the bedside. The ideal resuscitation fluid has not been identified. The investigators aim to use this new bedside technology to establish the microcirculation properties of two popular resuscitation fluids.

NCT ID: NCT05350592 Recruiting - Clinical trials for Acute Myocardial Infarction

Low-Dose Dobutamine and Single-Dose Tocilizumab in Acute Myocardial Infarction With High Risk of Cardiogenic Shock

DOBERMANN
Start date: March 7, 2022
Phase: Phase 2
Study type: Interventional

In the present study, we aim to investigate the effects of dobutamine infusion and/or a single intravenous (IV) dose of the IL-6 antagonist Tocilizumab administered after percutaneous coronary intervention (PCI) to patients with acute myocardial infarction (AMI) presenting < 24 hours from onset of chest pain and an intermediate to high risk of cardiogenic shock (CS) by assessment with the ORBI risk score (≥10 - not in overt shock at hospital admission). Plasma concentrations of pro-B-type natriuretic peptide (proBNP) as a proxy for development of cardiogenic shock (CS) and hemodynamic instability will be sampled for primary endpoint analysis. Effects on clinical parameters, mortality, morbidity as well as specific indicators of inflammation, cardiac function, and infarct size will secondarily be assessed noninvasively. The rationale behind the current study is that inflammatory and neurohormonal responses are associated with subclinical hemodynamic instability in patients with AMI with high risk of CS have worse outcomes. The potentially unstable condition may be targeted pharmacologically as an add-on to existing therapy. This is investigated in patients at elevated risk of CS by sampling biomarkers reflecting the inflammatory and neurohormonal responses, as well as determining effects on patient outcomes and infarct size.

NCT ID: NCT05349370 Recruiting - Sepsis Clinical Trials

Lactate Kinetics in Septic Shock

LKISS
Start date: December 28, 2022
Phase: N/A
Study type: Interventional

Lactate kinetics will be studied in hospitalized septic patients using a bolus injection of stable isotopically labeled lactate.

NCT ID: NCT05336357 Recruiting - Clinical trials for Acute Kidney Injury Due to Circulatory Failure

Non-invasive Goal-directed thErapy oN cIrcUlatory Shock

GENIUS
Start date: May 1, 2022
Phase: N/A
Study type: Interventional

Circulatory shock occurs when the supply of oxygen in the tissues decreases, which leads to cell damage and affects about one third of patients admitted to Intensive Care Units (ICU). Cardiac Output (CO) can be defined as the volume of blood ejected by the left ventricle per minute and is a very useful hemodynamic parameter in the monitoring of patients with signs of circulatory shock, since it can help define the etiology and management of such patients. Nevertheless, this parameter is underused in patients treated in Emergency Units, as its measurement usually involves invasive methods and few are available in this scenario. The pulmonary artery catheter is considered the gold standard method for determining the cardiac output, however, since it is an invasive method, in recent decades other devices capable of providing this hemodynamic variable in a less invasive way have been developed. Any method capable of providing CO without the need for pulmonary artery catheter insertion is called minimally invasive CO monitoring. The potential advantages of using these methods include the simplicity of measurements, faster acquisition of hemodynamic parameters and the possibility of implementing a monitoring strategy in places such as emergencies and emergency rooms. The evaluation of these parameters allows a faster determination of the etiology of circulatory shock, which enables the early initiation of goal-guided therapy. It is known that the use of goal-guided therapy proved to be effective in reducing peri- and postoperative morbidity and mortality in patients with high surgical risk; this strategy is also associated with reduced mortality, length of stay in the ICU and on mechanical ventilation in patients admitted to the ICU who are fluid responsive. To date, there is no data regarding the impact of a hemodynamic optimization strategy on patients in the first hours of shock. The investigators aim to assess whether goal-based hemodynamic therapy, through non-invasive hemodynamic monitoring, reduces the incidence of acute renal failure in patients with circulatory shock. A multicenter, randomized, open-label study will be carried out. The study will include patients over 18 years of age with signs of shock (systolic blood pressure less than 90 mmHg and/or mean arterial pressure less than 70 mmHg plus at least one of the following changes: lactate greater than 15 mg/dL, oliguria, neurological changes, and capillary refill time greater than 3 seconds) and who have signed an informed consent form (ICF). Included patients will be randomized in a 1:1 ratio into two groups. The Goal-Directed Therapy Group will be the one in which patients will be monitored by the ClearSightâ„¢ System (Edwards Life Sciences, Irvine, CA, USA) in the first 24 hours after randomization, where the parameters cardiac index (CI), systolic volume (SV), systolic blood pressure (SBP) and mean arterial pressure (MAP) will be used to determine medical management; if the CI is less than 2.2 L/min/m² and the SV less than 35 mL/beat, an aliquot of 500 mL of crystalloid solution will be administered; if the patient presents with CI less than 2.2 L/min/m², associated with SV greater than 35 mL/beat, dobutamine will be initiated; in patients with SBP less than 90 mmHg and/or MAP less than 70 mmHg, associated with SV greater than or equal to 35 mL/beat, norepinephrine will be initiated. In the Conventional Therapy group, the allocated patients will be treated according to the assistant team, where the following parameters will be evaluated: blood pressure, peripheral oximetry, heart rate, respiratory rate, and urine output; patients showing signs of hypovolemia will receive crystalloid solution; those who remain with hypotension refractory to volume replacement will be given vasoactive drugs; those with suggestive of cardiogenic shock will be given inotropic drugs; these procedures will be determined according to the clinical judgment of the assistant team.