Shock

Researchers are evaluating the safety and effectiveness of VBI-S in raising blood pressure in patients suffering from septic shock with absolute or relative hypovolemia. Septic shock is a severe condition caused by infection leading to dangerously low blood pressure that does not improve with standard fluid treatments. This study is a Phase III, open-label, randomized controlled trial sponsored by Vivacelle Bio, aiming to address this urgent medical emergency. Participants will receive treatment with VBI-S, which consists of small particles of specific lipids called micelles and liposomes designed to treat hypotension. The study is randomized and controlled but open-label, meaning both participants and researchers know the treatment given. The Data Safety Monitoring Board will regularly review safety and study data to ensure participant well-being. During the study, participants will be closely monitored through various assessments including measurements of mean arterial pressure, doses of pressor drugs, organ function scores, oxygen levels, serum markers, and survival rates over a 12-month period. The primary outcome is the elevation in average mean arterial pressure. Assessments will help determine how VBI-S affects blood pressure and organ function while ensuring ongoing safety throughout the study duration.

The trial investigates the use of left ventricular LV unloading via intra-aortic balloon pumping IABP to improve weaning success from venoarterial extracorporeal membrane oxygenation VA ECMO in patients with cardiogenic shock. The study is part of the REMAP ECMO platform, which embeds multiple response adaptive randomized trials within a patient registry. This research aims to fill knowledge gaps about managing ECMO and related therapies, as current practices rely mostly on observational data and expert opinion. Patients are randomized to receive either VA ECMO support with LV unloading through IABP or VA ECMO alone without an unloading device. The IABP must be placed within 8 hours of ECMO initiation for those in the unloading arm. The study also includes a nested physiological substudy assessing the effects of IABP on respiratory and hemodynamic parameters, including microcirculation, macrocirculation, and the impact of positive end-expiratory pressure PEEP as an unloading method during decremental PEEP trials. Participants undergo a range of assessments including evaluation of ECMO weaning success at 30 days, mortality rates at 30 days, 90 days, and 1 year, and various clinical parameters during ECMO support such as bleeding events, mechanical ventilation duration, heart function, and quality of life at one year. The physiological substudy collects detailed measurements like heart rate, pulmonary artery catheter data, echocardiography, microcirculation, respiratory parameters, and biomarkers at 24 and 48 hours after ECMO initiation. The study involves long-term follow-up up to one year and tracks health care costs and hospital readmissions.

Researchers are evaluating the safety and efficacy of centhaquine citrate LYFAQUIN173, a new drug for treating hypovolemic shock, a serious condition caused by severe blood or fluid loss. This phase IV, prospective, multi-center, open-label study builds on previous findings that centhaquine can improve blood pressure, reduce blood lactate levels, increase cardiac output, and reduce death rates by acting on specific adrenergic receptors to improve blood flow. Participants with hypovolemic shock aged 18 years or older and a systolic blood pressure of 90 mmHg or lower at hospital admission will receive centhaquine in addition to standard shock care. Centhaquine is given intravenously at a dose of 0.01 mgkg body weight over one hour in saline. A second dose may be given if blood pressure remains low, with a maximum of three doses in 24 hours, and treatment can continue for up to two days after enrollment. During hospitalization, participants will be closely monitored and followed until discharge or seven days after enrollment. Researchers will measure safety by tracking adverse events and serious adverse events up to seven days. They will also assess blood pressure, blood lactate, base deficit, time in intensive care, ventilator use, urine output, mortality rates, and organ function scores. Statistical analyses will compare patient outcomes to evaluate centhaquines effects.

This observational study focuses on patients experiencing cardiogenic shock who require intensive care management with Impella support. The main goal is to develop algorithms that can determine cardiac output by synchronously acquiring hemodynamic data from devices like the pulmonary artery catheter or other pressure sensors alongside the Impella system. This approach aims to potentially replace invasive hemodynamic monitoring in the future. Participants in this study will be monitored while receiving Impella support, with data collected from continuous or discontinuous cardiac output measurements such as pulmonary catheters or echocardiography. The study collects hemodynamic parameters including cardiac output, blood pressure, pulmonary artery pressure, central venous pressure, pulmonary capillary wedge pressure, mixed venous saturation, and pulmonary vascular resistance during the period from Impella insertion until support is permanently weaned, which typically lasts around two days. During their participation, patients will have their hemodynamic data continuously recorded and analyzed to aid algorithm development. Researchers will also track patient survival after Impella support ends. The study involves no intervention beyond standard care, focusing on data acquisition and monitoring. Total participation duration aligns with the time the Impella device is in use, averaging about two days.

Researchers are evaluating the safety and effectiveness of early versus standard continuous renal replacement therapy CRRT in patients with advanced cardiogenic shock who develop acute kidney injury stage 2 or higher while on veno-arterial extracorporeal membrane oxygenation VA-ECMO. This trial aims to determine the best timing for starting CRRT to improve outcomes in this critically ill population, as previous observational studies have suggested benefits but no randomized trials have confirmed optimal timing. Participants will be randomly assigned to one of two groups an accelerated group where CRRT starts as soon as possible and within 6 hours after meeting eligibility, and a standard group where CRRT begins only if certain clinical criteria develop, such as severe potassium imbalance, metabolic acidosis, high blood urea nitrogen, or refractory fluid overload. These approaches will be compared to assess their impact on patient outcomes during the study period. During the trial, participants will be monitored for various clinical outcomes including mortality, dependence on renal replacement therapy at 90 days, successful weaning from VA-ECMO, bleeding events, duration of intensive care, and other complications. The study includes assessments up to 12 months after enrollment to track longer-term outcomes. Data collection involves clinical evaluations, laboratory tests, and monitoring of organ function over time to understand the effects of CRRT timing on recovery and survival.

Researchers are conducting a study called Acutelines, a large data and biobank project at the University Medical Center Groningen in the Netherlands. It focuses on patients with a wide range of acute medical conditions who present to the Emergency Department. The goal is to improve how acute diseases are recognized and treated, understand their outcomes, and support personalized medicine by collecting detailed clinical data, imaging, and biomaterials over time. Participants have their medical information, including demographics, health status, medical history, vital signs, diagnostic tests, and treatments, systematically collected. Biomaterials such as blood, urine, feces, and hair are gathered from patients who meet certain severity criteria. Data collection occurs during hospital admission, including continuous monitoring, and continues with follow-ups at 3 months, 1 year, 2 years, and 5 years after the initial emergency visit. Throughout the study, various assessments are performed, such as quality of life, physical functioning, mental health, symptoms, and hospital length of stay. Researchers collect data on mortality and other health outcomes for up to 50 years. The study uses digital tools to automate data capture and integrates information from multiple healthcare sources. Participants will be monitored closely during hospitalization and at scheduled intervals afterward to help improve understanding and treatment of acute diseases.

Sepsis is a serious condition caused by the bodys uncontrolled response to infection, which can lead to septic shock, a life-threatening state. This research evaluates whether adding fludrocortisone to the standard treatment with hydrocortisone might improve outcomes for critically ill patients in shock. The study is a Phase II pilot trial designed to test the feasibility of a larger international study that would confirm if this combination therapy can reduce mortality in septic shock. The trial is a randomized, double-blind, placebo-controlled study conducted in six intensive care units across Hong Kong, Australia, and Singapore. Participants will receive either 100 mcg of enteral fludrocortisone daily or a placebo for up to seven days, alongside standard intravenous hydrocortisone given every six hours. The treatment period lasts until discharge from the ICU or death, whichever occurs first. Participants will be critically ill adults who have septic shock and require mechanical ventilation. Researchers will monitor protocol adherence, recruitment rates, time to shock resolution, mortality at 28 days, days free of organ support, and severe electrolyte imbalances. The study includes detailed tracking of feasibility outcomes, data completeness, and safety over approximately 20 months, with the aim of informing a larger future trial.

Researchers are evaluating the effectiveness of two drugs, adrenaline and dopamine, for treating fluid refractory septic shock in children. This serious condition requires urgent treatment, and the study aims to compare how well these drugs work by measuring heart rate, Glasgow Coma Scale GCS, capillary refill time, peripheral pulse, urine output, and systolic blood pressure. This randomized control trial focuses on children diagnosed with this type of septic shock to determine which drug better corrects these vital parameters over time. Participants will be randomly assigned to receive either adrenaline at a dose of 0.1-0.3 micrograms per kilogram per minute or dopamine at a dose of 10-20 micrograms per kilogram per minute once diagnosed with fluid refractory septic shock. These drugs will be administered continuously during the trial period, and the treatment groups include Group A adrenaline and Group B dopamine. The study does not involve any masking or blinding, and treatments are given based on random assignment. During the study, researchers will monitor participants closely for changes in blood pressure, pulse, capillary refill time, urine output, and GCS over a 6-hour period. Additional assessments include the Sequential Organ Failure Assessment SOFA score at 6 hours to evaluate organ function. The trial will enroll children aged 1 month to 12 years, and their vital signs and clinical status will be tracked to compare the effects of the two drugs. The participation duration covers the critical early hours of treatment when fluid refractory septic shock is addressed.

Septic shock is a severe condition with high mortality worldwide. Researchers are evaluating whether giving albumin together with crystalloid fluids early in treatment improves survival compared to using crystalloid fluids alone. This study is a phase 4 randomized controlled trial designed to assess the benefits of albumin in initial fluid resuscitation for patients with septic shock. Participants are randomly assigned to one of two groups. The treatment group receives 200 cc of 20% human albumin plus 15 cc per kg of crystalloid fluid over 1 to 2 hours. The control group receives 30 cc per kg of crystalloid fluid alone, following usual care practices. Physicians can choose the type of crystalloid fluid used, such as balanced fluid or isotonic saline. During the study, participants survival is tracked with the primary outcome being 28-day all-cause mortality. Additional outcomes include 7-day, 90-day, ICU, and hospital mortality, organ failure scores, ICU stay length, ventilator and vasopressor-free days, fluid amounts given, kidney therapy needs, and safety parameters. The study monitors participants from enrollment and continues until final outcome assessments, ensuring comprehensive follow-up for up to 90 days.

Researchers are collecting detailed information on patients experiencing cardiogenic shock CS, a severe type of acute heart failure, who are admitted to Intensive Coronary Care Units. The study aims to better understand the profile, management, outcomes, and progression of these patients over time. It addresses the need for improved clinical classification and research on the varied causes and presentations of CS, especially given its high short-term mortality and the importance of specialized care centers. This observational registry includes all patients with cardiogenic shock admitted to Intensive Coronary Care Units from January 2020 through December 2030. The study tracks multiple clinical factors including the cause of shock, clinical presentation, current treatments, use of mechanical support devices, and patient outcomes. There are no interventions or treatments assigned by the study as it is focused on data collection and analysis. Participants will be followed for up to 10 years to monitor their clinical course, re-hospitalizations, and other outcomes. Researchers will collect information on clinical characteristics, management approaches, and patient evolution during their stay and long-term follow-up. The study involves reviewing medical data over this period to provide insights into how cardiogenic shock patients are treated and how they fare over time.