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Showing 1-20 of 235 trials
NCT05148026
Anticoagulation is an essential component of all extracorporeal therapies. Currently locoregional citrate anticoagulation is the recommended technique for continuous renal replacement therapy (CRRT). However, low clearance of citrate restricts its use to blood flow up to 150 mL/min, preventing its use in ECMO. Renal replacement therapy (RRT) is commonly provided to ECMO patients with AKI. In presence of systemic heparinization for ECMO, additional anticoagulation for the CRRT circuit (i.e. RCA) is usually not employed. Nevertheless, thrombosis occurs more frequently in the CRRT circuit than the oxygenator because of the slower blood flow. The aim of this prospective, cross-over study is to assess, in patients undergoing CRRT during veno-venous ECMO (vv-ECMO), the efficacy and safety of adding regional citrate anticoagulation (RCA) for CRRT circuit anticoagulation.
NCT07389018
The study aims to assess the feasibility/acceptability of real-world activity monitoring by the Syde® wearable device in PSP-R. The Syde® collected data will be compared to on-site conventional clinical endpoints, including functional capacity and cognitive assessments, as well as core scales assessments.
NCT05337059
Expiratory or inspiratory transpulmonary pressures have been proposed to optimize ventilator settings in patients with ARDS. The aim of this study is to assess the feasibility and the physiological effects of a new method based on both expiratory and inspiratory transpulmonary pressures.
NCT04068012
Previous clinical trials in adults with acute respiratory distress syndrome (ARDS) have demonstrated that ventilator management choices can improve Intensive Care Unit (ICU) mortality and shorten time on mechanical ventilation. This study seeks to scale an established Clinical Decision Support (CDS) tool to facilitate dissemination and implementation of evidence-based research in mechanical ventilation of infants and children with pediatric ARDS (PARDS). This will be accomplished by using CDS tools developed and deployed in Children's Hospital Los Angeles (CHLA) which are based on the best available pediatric evidence, and are currently being used in an NHLBI funded single center randomized controlled trial (NCT03266016, PI: Khemani). Without CDS, there is significant variability in ventilator management of PARDS patients both between and within Pediatric ICUs (PICUs), but clinicians are willing to accept CDS recommendations. The CDS tool will be deployed in multiple PICUs, targeting enrollment of up to 180 children with PARDS. Study hypotheses: 1. The CDS tool in will be implementable in nearly all participating sites 2. There will be \> 80% compliance with CDS recommendations and 3. The investigators can implement automatic data capture and entry in many of the ICUs Once feasibility of this CDS tool is demonstrated, a multi-center validation study will be designed, which seeks to determine whether the CDS can result in a significant reduction in length of mechanical ventilation (LMV).
NCT07370610
Acute Respiratory Distress Syndrome (ARDS) is characterized by severe hypoxemia and extensive lung injury. Recent studies indicate that lung functional phenotypes - particularly the distribution and evolution of lung perfusion - may be closely related to patient outcomes. Electrical impedance tomography (EIT) offers non-invasive, bedside, real-time monitoring of lung perfusion patterns and enables classification into distinct phenotypes and trajectory types over the course of illness. To date, limited data exist on perfusion phenotype trajectories in ARDS patients and their relationship with clinical outcomes. This study seeks to characterize dynamic lung dynamic ventilation-perfusion functional Phenotype using EIT and explore their prognostic significance. Objectives Primary Objective: To identify lung perfusion phenotype trajectories in ARDS patients using EIT and assess their association with 28-day mortality. Secondary Objectives: * To determine the relationship between different trajectory types and improvements in oxygenation and respiratory mechanics. * To investigate how ventilator settings (PEEP, driving pressure) interact with perfusion changes. * To support individualized mechanical ventilation strategies based on Ventilation-Perfusion Functional Phenotype monitoring
NCT07504731
This multicenter, physiological, observational study hypothesizes that in moderate to severe ARDS, trunk inclination unloads the chest wall, but its impact on lung mechanics depends on PEEP levels and lung recruitability.
NCT06703073
This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design. Participants will be randomized to receive either a placebo or one of the active treatments. This record describes the default procedures and analyses for all cohorts. Each specific cohort may have additional eligibility requirements, safety and efficacy procedures, or endpoints, which will be described in the corresponding intervention-specific records on clinicaltrials.gov listed below in the detailed description.
NCT06611982
The goal of this clinical trial is to learn if providing advanced cancer patients with $1000/month for 12 months will improve cancer outcomes. The main questions it aims to answer are: To what extent does receiving $1000/month additional income reduce financial hardship? To what extent does receiving $1000/month additional income improve quality of life? Does receiving $1000/month additional income improve survival outcomes? Participants will: Receive $1000/month for 12 months Complete a survey every 3 months for 12 months If selected, participate in semi-structured interviews about their financial behaviors
NCT07123961
Acute respiratory distress syndrome (ARDS) is a serious and potentially life-threatening lung condition that can affect children. Currently, ventilator settings commonly used in treatment are based on approaches developed for adults, and it remains unclear whether these settings are equally effective for children. Because children's bodies respond differently than adults', it is important to determine the most effective ventilator strategies specifically for pediatric patients. This study will compare two different ventilator approaches in children with ARDS to identify which method provides the greatest benefit. The findings will also help inform the design of a larger study in the future.
NCT07463885
Acute hypoxemic respiratory failure may progress to acute respiratory distress syndrome, a life-threatening condition that often requires mechanical ventilation. The optimal ventilation strategy in this patient population remains uncertain. The SVALBARD trial is a feasibility and pilot study designed to compare spontaneous versus controlled mechanical ventilation in patients with acute hypoxemia respiratory failure. The primary objective is to assess the feasibility of the study procedures and interventions, while also collecting descriptive data on key clinical variables to inform the design of a future randomized controlled trial.
NCT07328555
Randomized controlled trial involving 4 pediatric primary care practices in Massachusetts. Practices will be stratified by their OM diagnosis and treatment rate, with two practices randomly assigned to the intervention arm and two to the control arm. For practices randomized to the intervention arm, their offices will be equipped with digital otoscopes (Wispr Digital Otoscope, WiscMed) in each exam room in place of traditional otoscopes. Clinicians in intervention practices will attend a two-hour initial training session on the use of digital otoscopy followed by two one-hour follow-up sessions held over a two-month run-in period prior to the study start to review best practices and troubleshoot any difficulties adapting to the new technology. Upon completion of the run-in training period, a six-month data collection period will begin. The primary outcome will consist of a difference-in-difference analysis comparing the difference in the OM Treatment Index (OMTI) from the baseline period (October 1 through March 31, 2025) to the intervention period (October 1 through March 31, 2026) between the intervention practices and the control practices. The OMTI is a measure of the rate of diagnosis and antibiotic treatment of OM, specifically calculated as the number of cases with an OM diagnosis and systemic antibiotic prescribed divided by the number of visits with a diagnosis of any acute respiratory tract illness. Secondary outcomes include analogous difference-in-difference comparisons of: 1) overall antibiotic courses prescribed; 2) overall days of antibiotics prescribed; and 3) a balancing measure of the rate of return visits with any acute respiratory tract illness diagnosis within 7 days of an index visit. Additionally, clinicians will be surveyed to assess confidence and satisfaction in diagnosing OM and preference for digital versus traditional otoscopy. To incentivize participation, practices randomized to the control arm will be loaned digital otoscopes to use for six months at the conclusion of the clinical trial.
NCT07449572
This Phase 1/2A, randomized, double-blind study will evaluate the safety, tolerability, and pharmacokinetics (PK) of HT31-1 (hCitH3-mAb) in healthy adult volunteers and in patients with mild-to-moderate acute respiratory distress syndrome (ARDS) due to an infectious source. The current trial (Part A) focuses on single ascending doses (SAD) in healthy volunteers to characterize the safety profile, PK parameters, and immunogenicity of HT31-1. Emerging data from this phase will inform dose selection for the subsequent Part B study in ARDS patients and help establish the recommended Phase 2 dose (RP2D). Additionally, exploratory pharmacodynamic and biomarker assessments will be performed to evaluate target engagement and potential early biological activity.
NCT07445061
Acute respiratory distress syndrome (ARDS) is a life-threatening condition with high mortality. Prone position ventilation (PPV) is an evidence-based therapy that improves oxygenation and survival in patients with moderate to severe ARDS; however, outcomes remain heterogeneous. Early identification of patients at high risk of mortality after PPV may improve clinical decision-making and individualized management. This retrospective observational study aims to develop and validate a machine learning model to predict intensive care unit (ICU) mortality in ARDS patients receiving prone position ventilation. Clinical, laboratory, and treatment variables collected from ICU electronic medical records will be used to construct prediction models using multiple machine learning algorithms. The performance of these models will be evaluated and compared to identify the optimal model for mortality prediction.
NCT06179771
Patients who are very ill either due to a severe infection, major organ injury, trauma or a major operation may require significant support with devices such as a dialysis machine for the kidneys or Extracorporeal Membrane Oxygenation (ECMO) for the heart and lungs. This is often due to a reaction of the body to the insult which is termed inflammation. The investigators would like to assess if the use of a device that can remove the agents driving this reaction can lead to a quicker recovery form the illness. The device is a blood filter called HA380 and it would be connected to either the dialysis machine or the ECMO circuit. The investigators want to assess the feasibility of conducting a study with the HA380 column. We will also evaluate if the use of the HA380 column has an effect on the time spent on dialysis or ECMO, time spent on the breathing machine, time spent requiring drugs to support blood pressure and time spent in the intensive care unit.
NCT07414056
The aim of this study is to evaluate the role of Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as predictors for development of ARDS in pediatric burn patients.
NCT06701669
This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design. Cohort B: Participants will be randomized to receive either a placebo or paridiprubart. This record describes the default procedures and analyses for Cohort B. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.
NCT07246837
Urine culture is the most common microbiological test in the outpatient setting in the United States. Unfortunately, contamination during collection is prevalent and undermines test accuracy, leading to incorrect diagnosis, unnecessary treatment, wasted laboratory resources, and inflated costs. Unnecessary antibiotic treatment increases the risk of developing antimicrobial resistance, one of the most serious threats to patients and public health. The goal of this clinical trial is to test whether a bilingual (English and Spanish) educational intervention, an animated video and pictorial flyer, can reduce urine culture contamination and associated inappropriate antibiotic use in adult patients visiting safety-net primary care clinics. The main questions it aims to answer are: 1. Does providing patients with a bilingual educational intervention reduce urine culture contamination rates? 2. Does the intervention lead to fewer unnecessary urinary antibiotic prescriptions? 3. Does providing patients with a bilingual educational intervention reduce contaminated urinalyses? Researchers will compare patients randomized to receive the educational intervention (video and flyer) to those receiving usual care to see if the intervention improves urine collection accuracy and reduces inappropriate antibiotic use. Participants will watch a short, animated video with step-by-step instructions for proper midstream clean-catch urine (MSCC) collection, receive a pictorial flyer (with stills from the video) reinforcing the instructions, and provide a urine sample for culture. Hypothesis: patients who receive the educational intervention will have: lower urine culture contamination rates (primary outcome), fewer urinary antibiotic prescriptions (secondary outcome), and fewer contaminated urinalyses (secondary outcome). The objectives are to (1) develop educational tools: Create an animated video and pictorial flyer with step-by-step urine collection instructions for women and men, developed through an iterative, stakeholder-engaged process, (2) assess acceptability: Use mixed methods (quantitative surveys and qualitative interviews) to evaluate and refine the tools for usability and cultural/linguistic appropriateness, and (3) test effectiveness: Conduct a randomized controlled trial to assess the intervention's impact on urine contamination rates, antibiotic prescribing, and patient satisfaction.
NCT04725110
Acute treatment of COVID-ARDS with direct topical lung instilled T3 therapy for patients on mechanical ventilation.
NCT05609188
The primary goal is to understand the potential impacts of Guaranteed Income (GI) on Black youth and young adults' financial, emotional, and physical well-being. The main question it aims to answer is: What are the impacts of GI on Black young adults' investments in their future, mental health and unmet mental and sexual/reproductive health service needs? Participants will receive guaranteed income for 12 months and will be offered enrollment in financial capability programs.
NCT07375849
This randomized controlled trial investigates the effects of prone positioning versus lateral positioning at different angles (30°, 90°, 120°) on pulmonary function improvement in patients with acute respiratory distress syndrome (ARDS). Utilizing electrical impedance tomography (EIT) technology, the study monitors key parameters including ventilation distribution and ventilation-perfusion matching in real time, while integrating respiratory mechanics and blood gas analysis data to comprehensively evaluate the therapeutic efficacy of positional adjustments. The study hypothesizes that high-angle lateral positioning may reduce adverse complications associated with prone positioning while effectively improving oxygenation and pulmonary function. The ultimate objective is to provide a safer and more personalized positional therapy regimen for clinical practice, optimizing ARDS treatment strategies to reduce mortality and enhance patient survival outcomes.