Acute Lung Injury

Researchers are evaluating the use of early near apneic ventilation compared to usual ultra-protective lung ventilation in patients with severe acute respiratory distress syndrome (ARDS) who are supported by venovenous extracorporeal membrane oxygenation (ECMO). The trial, named CALMDOWN, is a prospective, open-label, multicenter, randomized controlled study aiming to investigate whether early apneic ventilation can help reduce ventilator-induced lung injury, ECMO duration, and mortality by day 60 in this critically ill population. Participants are randomly assigned to one of two groups: one group receives near apneic ventilation during the first 3 days of ECMO using BIPAP/APRV or pressure-controlled ventilation with specific settings to maintain airway pressure and minimize ventilation rate. Neuromuscular blockade and sedation may be used as needed. After 3 days, apneic ventilation may continue or switch to ultra-protective lung ventilation at the physician's discretion. The other group receives standard ultra-protective lung ventilation throughout ECMO support with defined ventilator settings. Prone positioning is allowed in both groups based on physician judgment. During the study, participants will be monitored closely for outcomes including mortality at day 60, need for lung transplantation, persistence of ECMO support, and days alive without ECMO from day 0 to day 60. Additional assessments cover mortality and other clinical outcomes up to day 90, duration of ventilation, ICU stay, hospital stay, and complications such as pneumonia, pneumothorax, and right ventricular function. The trial is sponsored by Assistance Publique - Hôpitaux de Paris and runs until May 2030.

Researchers are studying lung mechanics during the early phase of mechanical ventilation in intensive care and during general anesthesia in surgical patients. The study aims to better understand lung compliance and transpulmonary driving pressures using a new, non-invasive PEEP-step method. This method could improve how ventilator settings are personalized to reduce lung injury and complications, addressing a gap in data collected during the critical first hours of ventilation. The study observes two groups: ICU patients receiving ventilator treatment and patients undergoing general anesthesia for surgery. In both groups, a PEEP-step method involves adjusting positive end-expiratory pressure (PEEP) up and down in one or two steps while measuring changes in lung volume and pressures. This is done directly after intubation and repeated during ventilation or surgery when clinical events occur, using specialized software that analyzes data from standard ventilator monitoring equipment. Participants will be monitored continuously during ventilator treatment or surgery. Measurements include lung elastance and transpulmonary driving pressure, collected before, during, and after respiratory care. Clinical data such as blood gases and ventilator settings are recorded without any invasive procedures. The study assesses lung function changes over time, ventilator duration, and postoperative complications, aiming to enhance ventilator therapy and patient outcomes. Total participation time varies with clinical course.

Researchers are evaluating whether a structured training program for intensive care unit (ICU) staff can reduce health problems known as post-intensive care syndrome (PICS) in adults after they leave the hospital. PICS includes new or worsened physical, thinking, or emotional difficulties following serious illness, which can affect daily life, independence, memory, mood, and overall quality of life. This multicenter study compares patients treated before and after ICU staff training, focusing on whether the training reduces PICS three months after hospital discharge. The study also compares standard training on the ABCDEF care bundle with an expanded A-Z bundle that includes additional care elements like nutrition, sleep, infection prevention, safety, and psychological support. The study involves a cluster-randomized design where entire ICUs are assigned to receive training on either the standard ABCDEF bundle or the expanded A-Z bundle. The training program for ICU staff includes a month-long online course with educational materials, checklists, pocket guides, and visual reminders, plus face-to-face sessions to reinforce learning. After training, ICUs continue usual care while researchers track how often the trained care practices are followed during patients' ICU stays, up to 21 days or until discharge or death. Follow-up visits for patients occur at 1, 3, 6, and 12 months after hospital discharge. Participants are adults who stay in the ICU for at least 48 hours and leave the hospital alive. They will undergo tests and questionnaires on physical health, memory, mood, and quality of life during follow-up visits. Data collection includes ICU care details and patient outcomes, monitored using electronic forms with quality checks. The main outcome measured is the number of participants who develop PICS three months after discharge. Secondary outcomes include adherence to care bundles, incidence of delirium, and quality of life assessments at various timepoints. The study runs until 2028 and maintains ethical and data protection standards throughout.

Researchers are studying patients with severe pneumonia admitted to the Respiratory Intensive Care Unit (RICU) to understand the epidemiology and clinical characteristics of pneumonia caused by various factors. This observational cohort study aims to gather detailed clinical data including morbidity, mortality, risk factors, symptoms, and radiographic changes to help improve clinical care for severe pneumonia patients. The study involves patients admitted to the RICU due to pneumonia from any cause. There are no specific treatments or interventions being tested, as this is an observational study collecting data during the patients' stay. Researchers will observe respiratory support parameters, treatment options, and symptom developments during the initial days and weeks of hospitalization. Participants will be monitored for outcomes such as mortality and morbidity during their time in the RICU, with measurements taken over one year. Data on symptoms within the first 48 hours, respiratory support during the first 5 days, and treatments over 3 weeks will be collected. The study records clinical information to better understand pneumonia in this critical care setting, with participant involvement lasting as long as their hospital stay and follow-up for outcomes.

Researchers are conducting a clinical study to develop an artificial intelligence (AI)-based clustering model to personalize medicine for patients with acute respiratory failure who are admitted to the intensive care unit (ICU). The study aims to confirm patient phenotypes and compare clinical characteristics and prognosis between patients requiring advanced oxygen support and a control group without acute respiratory failure. Participants are divided into two groups: those with acute respiratory failure requiring treatment with high flow nasal cannula (HFNC), non-invasive ventilation (NIV), or mechanical ventilation (MV), and a control group who do not need these treatments. Both groups are admitted to the internal medicine ICU at Samsung Seoul Hospital and undergo the same research procedures. During the study, participants' clinical information is collected prospectively for analysis. Researchers will assess hospital mortality up to one year from admission, ICU mortality up to six months, and length of stay in both hospital and ICU. The study involves monitoring patients from admission until discharge or death, with follow-up periods varying up to one year. This observational study is sponsored by Samsung Medical Center.

Researchers are studying the safety and tolerability of human umbilical cord mesenchymal stem cell injections for adults aged 18 to 80 with moderate to severe acute respiratory distress syndrome (ARDS) caused by infection. This Phase I-II open-label trial also explores the appropriate dosage, potential effects on the immune system, and how the treatment behaves in the body over time. Participants receive a single dose of stem cells delivered through a vein, with doses ranging from 5 x 10^7 to 2 x 10^8 cells. The study does not include a placebo group and focuses on dose escalation to assess safety. The trial is sponsored by Changchun Tuohua Pharmaceutical Co., Ltd. During the 28 days following treatment, participants will have their vital signs, lab tests, lung function, organ failure status, and oxygen levels monitored regularly. Researchers will track any side effects, mortality rates, and time spent without mechanical ventilation or intensive care. Long-term follow-up is also part of the study to further assess safety and effects.

This research aims to evaluate interventions to support family members who act as surrogate decision makers for critically ill patients in Intensive Care Units (ICUs). These surrogates often face intense grief and stress that can affect their mental health and the quality of decisions made for their loved ones near end-of-life. The study focuses on reducing symptoms of prolonged grief disorder (PGD), post-traumatic stress disorder (PTSD), and related emotional challenges through a psychological intervention called EMPOWER. The study compares two approaches: the EMPOWER intervention, which is a brief, cognitive-behavioral and acceptance-based treatment delivered by trained mental health professionals, and a Supportive Conversation (SC) that provides empathetic support without specific skill-building. EMPOWER includes six 15-minute modules and two booster phone sessions, totaling about 90 minutes plus follow-ups, while the Supportive Conversation matches this time with supportive interaction and follow-up calls. Participants are assessed up to four times before and after the intervention within three months. Participants, who are surrogate decision makers of ICU patients near end-of-life, will complete assessments on grief, PTSD, depression, regret, anxiety, and distress before the intervention, immediately after, and at 3 and 12 months follow-up. The study also includes interviews with some participants to better understand the intervention's effects and contextual factors during the COVID-19 pandemic. The primary outcomes focus on changes in grief and PTSD symptoms over twelve months, with safety and mental health monitored throughout the study period.

Researchers are evaluating the safety and effectiveness of a single intravenous dose of agenT-797 combined with standard of care (SOC) compared to placebo plus SOC in adults with severe pneumonia and moderate to severe acute hypoxemic respiratory failure (AHRF). The study aims to reduce short-term mortality in this patient group and is conducted in two parts: an initial Run-in Phase and a Phase 2 randomized, double-blinded phase. All participants receive SOC management for severe pneumonia and acute respiratory distress syndrome (ARDS). In the Run-in Phase, participants receive open-label agenT-797 plus SOC to help characterize the baseline population. After this phase, participants are randomized to one of two groups in Phase 2: agenT-797 plus SOC or placebo plus SOC. Both treatments are given as intravenous infusions, and SOC includes antimicrobial therapy and corticosteroids following guidelines. Participants will be monitored from Day 1 through Day 28 for outcomes such as mortality, days without oxygen support or ventilator use, time to resolution of hypoxemia, ICU-free days, infections, antibiotic-free days, and time to hospital discharge. Additional measurements include mortality at Day 90 and changes in cytokine profiles at baseline and on Days 3, 7, and 14. The study includes safety monitoring and assessments throughout the trial period, which is expected to end in August 2027.

Researchers are evaluating the effectiveness of three glucocorticoid drugs—methylprednisolone, dexamethasone, and hydrocortisone—in patients with acute respiratory distress syndrome (ARDS). ARDS is a serious condition caused by severe inflammation in the lungs, often following pneumonia or sepsis, leading to breathing difficulties. The study aims to compare these drugs at equivalent doses to understand their impact on inflammation and lung function in ARDS patients. The study involves three groups of 100 patients each, receiving either methylprednisolone at 1 mg/kg/day, dexamethasone at 13 mg/day, or hydrocortisone at 350 mg/day. These drugs are given during the early phase of ARDS, when inflammation is most active. The study is randomized and does not use masking. Participants receive treatment and are monitored closely during a 28-day period. Participants will be assessed for outcomes such as 28-day mortality, need for invasive mechanical ventilation, number of ventilator-free days, length of ICU stay, hospitalization duration, and occurrence of serious side effects like infections and high blood sugar. The study includes chest imaging and oxygen level monitoring to confirm ARDS diagnosis and track progress. The total participation period for each patient is 28 days from enrollment.

This research aims to learn more about vitamin C deficiency in patients with either acute or chronic diseases. It focuses on understanding how symptoms change over time and how well patients tolerate treatment. The study involves patients diagnosed with vitamin C deficiency either by lab tests or based on symptoms such as fatigue, infections, bleeding gums, joint pain, and poor wound healing. The study observes patients treated with Vitamin C Injektopas® 7.5 g, given for an expected average of about 3 weeks for acute diseases or 12 weeks for chronic diseases. Two groups are included: those with acute underlying diseases and those with chronic underlying diseases, both receiving this vitamin C therapy during the study period. Participants will be followed to assess changes in general and disease-specific symptoms, as well as treatment tolerability and overall effectiveness from the patient's perspective. Researchers will also record the number of vitamin C infusions and measure quality of life for chronic disease patients. The study duration ranges up to approximately 12 weeks, with evaluations at the last visit to understand symptom improvement and treatment impact.