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Showing 1-20 of 677 trials
NCT07657832
To assess the role of SHI in SWL outcomes for upper urinary tract calculi in pediatric population.
NCT07626645
Lower extremity lymphedema is a chronic and progressive condition associated with significant functional impairment and reduced quality of life. The current gold-standard treatment is Complex Decongestive Therapy (CDT); however, a substantial proportion of patients continue to experience persistent symptoms during the maintenance phase. This prospective, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) as an adjunct to standard CDT maintenance therapy in patients with lower extremity lymphedema. Participants will be randomly allocated to either an active ESWT group or a sham ESWT group, with both groups continuing standard CDT maintenance throughout the study. ESWT will be administered twice weekly for five sessions. Changes in limb volume, skin thickness and subcutaneous tissue thickness assessed by ultrasonography, pain, functional status, and quality of life will be evaluated at baseline, after treatment, and at one-month follow-up.
NCT06846723
Extracorporeal shock wave lithotripsy (ESWL), a minimally invasive procedure, is used in the treatment of urolithiasis. The shock waves used in this procedure, which does not require any incision, cause pain in the superficial structures of the body such as skin, muscles and deep structures such as costae, nerves and kidney tissue. This pain may cause patients not to tolerate the treatment, delay in recovery, decrease in the effectiveness of the treatment and decrease in satisfaction. Patients may also experience anxiety about the procedure prior to treatment. Anxious patients experience more pain during ESWL. Pain and anxiety increase the activation of the sympathetic nervous system and neuroendocrine response, leading to physiologic changes such as increased blood pressure, heart rate and oxygen requirement of the body. This may negatively affect the vital signs of the patients. Therefore, it is essential to relieve pain and anxiety in patients undergoing ESWL and pharmacologic and nonpharmacologic methods are used for this purpose. Pharmacologic methods such as analgesics, opioids and sedative agents are used to reduce pain and anxiety in patients. Since these methods have side effects such as nausea, vomiting, gastric bleeding, respiratory depression, tachycardia, constipation, the use of non-pharmacological methods that can be applied by nurses is increasing. One of the non-pharmacologic methods is the stress ball, which uses the sense of touch to divert attention with cognitive focus. In this simple, reliable, cheap and easily accessible method, pain and anxiety are reduced by directing the mind to the attention-grabbing stimulus.
NCT07582926
This prospective observational study aims to evaluate the prognostic value of cortisol levels and their dynamic changes in critically ill patients with sepsis and septic shock admitted to the intensive care unit. Cortisol plays a crucial role in maintaining hemodynamic stability and modulating the inflammatory response during critical illness, and relative adrenal insufficiency has been associated with worse clinical outcomes. Adult patients admitted to the intensive care unit with sepsis or septic shock will be enrolled and followed prospectively. Serum cortisol levels will be measured, and their association with clinical outcomes, including intensive care unit mortality, 28-day mortality, and 90-day mortality, will be analyzed. In addition, the relationship between cortisol levels and disease severity scores such as SOFA and APACHE, as well as laboratory parameters including inflammatory biomarkers, will be evaluated. The findings of this study are expected to contribute to the early identification of high-risk patients and improve prognostic assessment in critically ill patients with sepsis and septic shock.
NCT07300306
The goal of this observational study is to validate the effectiveness of the new SOFA-2 score in predicting mortality and to determine the current frequency of sepsis in adult patients admitted to Intensive Care Units (ICUs) in Turkey. The main questions it aims to answer are: * Does the SOFA-2 score accurately predict 30-day mortality in ICU patients? * What is the prevalence of Sepsis-3 and septic shock in Turkish ICUs? Researchers will compare the new SOFA-2 score to the existing SOFA-1 score to see if the new score provides better predictive accuracy for patient outcomes. Participants will not receive any experimental intervention. Researchers will collect data from routine medical care, including: * Vital signs, laboratory test results, and details of organ support (such as mechanical ventilation or dialysis) during the first 24 hours of admission. * Survival status at 30 days.
NCT07550400
Fluid replacement is considered the cornerstone of hemodynamic management in critically ill patients especially in patients with septic shock. However, only about 50% of critically ill hemodynamically unstable patients are responsive to fluids. Consequently, the resuscitation of critically ill patients requires an accurate assessment of the patients' intravascular volume status and their volume responsiveness. In this study, we will compare the efficacy of carotid artery flow to echo left ventricular end diastolic volume as a predictive value for fluid resuscitation in septic shock patients.
NCT07547020
Hemodynamic instability is a common and serious condition in patients undergoing liver transplantation and is associated with increased morbidity and mortality if not promptly recognized and treated. It results from multiple interacting factors, including blood loss, changes in vascular tone, cardiac dysfunction, and complications related to the surgical procedure. Traditional monitoring strategies focus on global hemodynamic variables such as blood pressure and cardiac output. However, these parameters may not accurately reflect tissue perfusion or oxygen delivery at the microcirculatory level. As a result, patients may appear hemodynamically stable while still experiencing inadequate tissue oxygenation. This study aims to evaluate hemodynamic instability using an integrative physiological approach based on the interaction between different components of the cardiovascular system. Specifically, the study will assess four key interfaces: the relationship between the heart and the arterial system, the coherence between macrocirculation and microcirculation, the interaction between venous return and the right atrium, and the coupling between the right ventricle and the pulmonary circulation. The main objective is to identify distinct hemodynamic profiles in patients during the immediate postoperative period following liver transplantation. In addition, the study will evaluate the incidence of tissue hypoxia within the first 24 hours and its association with clinical outcomes, including 30-day evolution. This is a prospective observational study conducted in adult patients admitted to the intensive care unit after liver transplantation who develop hemodynamic instability requiring vasoactive support. During the first 24 hours, multimodal hemodynamic monitoring will be performed, including assessment of cardiac function, vascular tone, venous congestion, pulmonary circulation, and markers of tissue perfusion such as lactate levels and capillary refill time. By integrating these variables, patients will be classified into different hemodynamic profiles according to the predominant underlying mechanism. This approach aims to improve the understanding of cardiovascular dysfunction in this setting and to support more individualized and physiologically guided management strategies.
NCT06638268
The goal of this clinical trial is to learn if acute transcatheter aortic valve implantation (TAVI) is superior to standard treatment (stabilization in an intensive care unit and TAVI subsequently) to treat cardiogenic shock in patients with critical severe aortic stenosis. The main questions it aims to answer are: • Does acute TAVI increase survival compared with standard treatment? Participants will: * Undergo either TAVI within 12 hours after admission or stabilization and TAVI 72 hours or more after admission * Visit an outpatient clinic and be evaluated for quality of life and heart function
NCT05800951
The CERAMICS study is designed to more clearly delineate the current care of acute myocardial infarction with cardiogenic shock (AMICS) patients who are treated with mechanical circulatory support (MCS) devices in the United States with significant experience in MCS, all of whom have the capability of MCS escalation on-site. Study enrollment is targeted at 120 patients at 20 hospital sites, evaluating clinical outcomes, and focusing on outcomes MCS escalation decision making and ICU level management.
NCT05092165
Hypotension is a common complication of intermittent renal replacement therapy. Methylene blue, an inhibitor of nitric oxide synthesis, has been suggested to improve hemodynamics during renal replacement therapy in ambulatory patients, but evidence is lacking for critically ill patients. This trial will assess whether methylene blue can improve hemodynamics and blood pressure for patients with shock requiring renal replacement therapy.
NCT07537621
Preload responsiveness and venous congestion have largely been investigated independently in recent literature. However, recent data report a similar incidence of venous congestion regardless of fluid responsiveness status, challenging the concept of a linear continuum between preload independence and fluid intolerance. These findings support the need for a more individualized hemodynamic management strategy that takes venous congestion risk into account. The right ventricle plays a central role in this framework. Its function is to maintain an adequate venous return pressure gradient to ensure cardiac output while limiting upstream venous congestion, under strong dependence on its afterload. In physiological conditions, the right ventricle adapts to changes in afterload by increasing contractility to preserve right ventriculo-arterial coupling and optimize its performance. In chronic cardiopulmonary diseases, right ventriculo-arterial uncoupling is a well-established prognostic factor, including the presence of occult uncoupling revealed by fluid loading. In critically ill patients, right ventricular systolic dysfunction associated with venous congestion-defining right heart failure-is strongly associated with increased mortality, as is right ventriculo-arterial uncoupling itself. To support the concept of fluid tolerance, the investigators hypothesize that impairment of right ventriculo-arterial coupling may exist or occur during fluid loading in critically ill patients, independently of preload responsiveness, and may be associated with worsening upstream venous congestion.
NCT04295252
The study will provide data on profile, management, outcome, and evolution over time of cardiogenic shock patients admitted to the Intensive Coronary Care Units
NCT07230041
The purpose of this study is to measure the change in plasma concentrations of antibiotics used during passage through the CRRT filter and hemadsorption cartridge in patients with septic shock and renal failure requiring CRRT. All patients aged \> 18 years, admitted to the ICU, diagnosed with septic shock and renal failure requiring CRRT, receiving antibiotic therapy with at least one of the following drugs: meropenem, linezolid, and daptomycin, who provided informed consent, are included in the study. Patients not admitted to the ICU, patients with renal failure not requiring CRRT, patients aged \< 18 years, or those who did not provide informed consent are excluded. The enrollment period will last 12 months and will run from September 2024 to September 2025. The expected number of patients enrolled is twenty. To proceed with the study, after starting antibiotic therapy, a 4 ml dose of blood will be drawn (Vacuette tube ref. 454092) before the cartridge, immediately after, and after the dialysis filter. This measurement will be repeated after 4, 8, and 12 hours, which represents the maximum usage time of the cartridge. After 12 hours, the cartridge becomes saturated and loses its adsorption capacity. The CRRT filter, however, remains in place for at least 72 hours before being replaced. Treatment is maintained until clinically necessary. For patients in intensive care, several blood samples are required throughout the day, both with a blood sample sent to the biochemistry laboratory every 6-8 hours to check clinical conditions, and with an arterial blood sample (blood gas) to check respiratory and metabolic status in patients on mechanical ventilation. Furthermore, in patients undergoing CRRT, electrolyte balance must be monitored every 4 hours. Therefore, the blood sample for the study inevitably coincides with one of the routine blood samples. The test tube, labeled with a unique code, will be sent to the central laboratory, which will centrifuge the blood and extract the plasma. This aliquot will then be stored at -80°C in a dedicated space and sent to the designated laboratory upon analysis. Determination of the plasma dosage of the antibiotic in use is commonly performed on patients admitted to the Intensive Care Unit, where clinically necessary. Participation in the study does not change current clinical practices.
NCT07527156
This study will evaluate the feasibility and safety of achieving therapeutic concentrations of beta-hydroxybutyrate using continuous infusion of D-beta-hydroxybutyrate monoester administered via a nasogastric tube in patients with acutely decompensated heart failure with reduced left ventricular ejection fraction.
NCT01473498
Sepsis is the most severe complication of infections. Sepsis-associated Acute kidney injury (AKI) is commonly encountered in critically ill patients and independently predicts poor outcome. Unfortunately, no drug or management strategy was able to reduce incidence of AKI. To adapt the level of mean arterial pressure according to local renal hemodynamic evaluated by renal Doppler could lead to a better renal perfusion, and then less AKI.
NCT07368738
The goal of this clinical trial is to learn if a non-opioid pain medicine regimen works as well as or better than a standard opioid-based regimen to manage pain during extracorporeal shockwave lithotripsy (ESWL) in adults. The main questions it aims to answer are: Does the non-opioid regimen lead to similar or better pain control during the procedure? Does the non-opioid regimen lead to similar or better procedure tolerability and side effect profile? The non-opioid regimen will use intravenous (IV) midazolam plus IV acetaminophen and IV ketorolac, and the standard opioid-based regimen will use IV midazolam plus IV fentanyl. Participants will be randomly assigned to receive one of the two medication regimens during ESWL, and asked to rate their pain before the procedure and 30 minutes after the procedure.
NCT07199998
The availability, effectiveness, and safety of menstrual protection represent a key public health issue. However, research on women's menstrual and sexual health remains extremely limited. Whether societal or pathological, many hypotheses are emerging regarding the effects of menstrual protection products, yet little attention has been given to the products themselves, their societal role, or their physiological and pathological consequences. Internal menstrual products, such as tampons and menstrual cups, are widely used but are subject to limited regulatory oversight, and few studies have investigated their long-term effects on vaginal health. This study aims to investigate how different types of menstrual protection influence vaginal microbiota, immune responses, and the recurrence of gynecological conditions such as bacterial vaginosis, mycosis, or dysbiosis. Biological samples (vaginal, cervical, urinary, and blood) will be collected to analyze vaginal microbiota composition and local immunity. Participants will be divided into three groups based on their main type of menstrual protection: menstrual cup users, tampon users, and external pad users. The study will compare these groups to assess potential differences in vaginal health and immune response related to menstrual product use.
NCT07367113
This prospective, randomized, controlled trial aimed to evaluate whether fluid resuscitation guided by the Peripheral Perfusion Index (PPI) could reduce the incidence of Acute Skin Failure (ASF) in elderly critically ill patients. A total of 216 patients aged ≥65 years with sepsis or other types of shock requiring early aggressive fluid resuscitation were enrolled and randomly assigned in a 1:1 ratio to either the PPI-guided resuscitation group or the conventional resuscitation group. The intervention group targeted maintaining PPI ≥1.4 in addition to conventional hemodynamic goals, while the control group followed standard resuscitation protocols. The primary outcome was the incidence of ASF within 7 days of ICU admission, diagnosed according to NPUAP/EPUAP (2014) criteria. Secondary outcomes included time to ASF occurrence, lactate clearance, cumulative fluid balance, organ function, and long-term prognosis.
NCT07516236
This prospective observational diagnostic accuracy study investigates the efficacy of dynamic central venous oxygen saturation in predicting fluid responsiveness in septic shock, compared to measurements obtained using echocardiography (VTI) and cardiometry. We will correlate the changes in measuring cardiac output by both echocardiography and cardiometry with the changes in dynamic central venous oxygen saturation both at baseline and after fluid challenge to investigate the efficacy of dynamic central venous oxygen saturation in predicting fluid responsiveness in septic shock.
NCT07515508
The goal of this observational study is to learn whether information collected during routine hospital care, together with blood and urine samples, can help doctors better identify different types of cardiogenic shock and better predict outcomes in adults hospitalized with acute heart failure and cardiogenic shock. The main question is whether clinical findings, imaging results, and biomarkers, including sex-specific factors, are associated with the risk of death within 30 days. Participants will not receive an experimental treatment. Researchers will collect data from routine care, collect additional blood and urine samples for biobanking, and follow participants after hospital discharge