Hypoalbuminemia, characterized by low levels of albumin in the blood, is often explored in clinical trials to evaluate various treatment approaches and their effects on patient outcomes. Studies commonly investigate intervention strategies aimed at i...
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Found 8 Actively Recruiting clinical trials
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Researchers are evaluating whether adding choline to ready-to-use therapeutic food (RUTF) can improve cognitive development in children aged 6 to 59 months with severe acute malnutrition (SAM) in Malawi. SAM affects millions of children worldwide, leading to increased risks of infection, hospitalization, death, stunted growth, and impaired cognitive development. Previous studies indicated that modifying the fatty acid content of RUTF improved brain development, and this study explores if adding choline, an essential nutrient for brain function, offers additional cognitive benefits. This trial compares two groups of children: one receiving RUTF with an added daily dose of 500 mg choline (C-RUTF) and the other receiving standard RUTF with only 5 mg choline for masking (S-RUTF). Both groups receive two sachets daily, providing approximately 1000 Kcal, 14g protein, 28g fat, and 14 micronutrients. Children are treated for up to 12 weeks or until recovery, with follow-up visits every two weeks to monitor health, growth, and RUTF supply. Participants undergo cognitive testing using the Malawi Developmental Assessment Tool (MDAT) at the end of treatment and again 5 to 7 months later to assess long-term development. Researchers collect blood samples and track recovery, growth rates, and health outcomes during treatment and follow-up. The study aims to measure differences in cognitive scores six months after treatment to determine if choline supplementation aids brain development in malnourished children.
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Researchers are evaluating how well the levels of a substance called N-terminal-proB-type-natriuretic-peptide (NTproBNP) in pleural fluid can identify pleural effusions caused by heart failure (HF). This observational study compares NTproBNP with other standard biochemical tests to see which better distinguishes heart failure-related pleural effusions from those caused by other conditions such as infections, malignancies, or fluid overload. The study is conducted by the Chinese University of Hong Kong and follows patient outcomes for up to three months to confirm the cause of pleural effusion. The study involves patients with pleural effusion who require thoracentesis to analyze the pleural fluid. Two groups are observed: those with pleural effusion due to heart failure and those with effusions from other causes. Researchers will measure pleural fluid levels of NTproBNP, albumin, protein, and lactate dehydrogenase (LDH). Heart failure diagnosis will be confirmed based on clinical features, serum NTproBNP, and echocardiogram results. No treatments are assigned, as this is an observational study. Participants will undergo pleural fluid sampling and clinical assessments including echocardiograms. Researchers will track biochemical markers and clinical factors such as comorbidities and nutritional status over 24 months. They will analyze how well NTproBNP levels correlate with heart failure diagnosis and patient prognosis. The main outcome is comparing the diagnostic accuracy of NTproBNP to other biochemical criteria for identifying heart failure-related pleural effusions. The study does not affect patient care and includes follow-up to monitor outcomes.
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Researchers are studying the effects of different dialysis parameters on the functional properties of albumin in patients undergoing hemodialysis for end-stage chronic kidney disease. This condition requires hemodialysis to survive but is associated with increased cardiovascular risks due to chronic inflammation and incomplete removal of toxins. The study aims to explore how dialyzer types and dialysis modes can therapeutically improve albumin function and overall treatment quality. Participants will receive treatments involving hemodialysis, hemodiafiltration, high-flux dialyzers, and low-flux dialyzers, each for a period of three months. This proof-of-concept interventional study will assess how these different dialysis approaches affect albumin's ability to bind and detoxify harmful substances. The study focuses on comparing the effects of dialysis mode and dialyzer characteristics over a total duration of nine months. Throughout the study, researchers will measure the level of irreversibly oxidized albumin (HNA-2) and evaluate albumin's binding and detoxification efficiency at the end of nine months. Participants will be monitored regularly during treatment to assess these outcomes. The study is sponsored by Universität Duisburg-Essen and aims to provide insights into improving long-term hemodialysis treatment quality by modifying albumin functions.
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Researchers are evaluating an individualized acute normovolemic hemodilution (ANH) technique to reduce the need for red blood cell transfusions during elective non-cardiac surgeries with expected major blood loss in adults aged 18 to 75 years. The study aims to address concerns about complications related to allogeneic blood transfusions and improve blood management during surgery by tailoring the ANH process to each patient using the West-China-Liu's Score. Participants in the trial will be randomly assigned to either receive individualized ANH based on the West-China-Liu's Score after anesthetic induction or to receive routine clinical care guided by standard transfusion guidelines. The individualized ANH involves collecting autologous blood while infusing fluids to maintain blood volume, with transfusions managed according to the patient's calculated tolerable hemoglobin level. This method aims to safely reduce red cell loss during surgery. During the study, researchers will monitor participants for the requirement of allogeneic blood transfusions up to 12 weeks post-surgery. Additional assessments include the proportion of patients receiving transfusions, in-hospital complications, duration of hospital and postoperative stays, and total hospital costs. Safety and outcomes will be evaluated through standard clinical monitoring throughout the hospital stay and follow-up period.
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Introduction: Postoperative delirium (POD) is a common complication in elderly surgical patients and is significantly associated with prolonged hospital stays, cognitive impairment, functional decline, and increased mortality rates within 6 to 12 months. Its incidence has been reported to range between 10% and 70%, depending on the diagnostic criteria used, the population studied, and the type of surgical procedure performed. The incidence is particularly higher following vascular, cardiac, and hip fracture surgeries. According to the 2024 updated guidelines by the European Society of Anaesthesiology and Intensive Care (ESAIC), POD should be screened at least once daily for a minimum of three days, beginning in the post-anesthesia recovery unit, based on the DSM-5 criteria. POD is a complex syndrome associated with various phenotypes and is likely the result of a combination of neuroinflammatory and oxidative stress processes. Candidate biomarkers for POD include inflammatory parameters (such as interleukins, C-reactive protein \[CRP\], erythrocyte sedimentation rate, and CD68), dopamine receptors, norepinephrine levels, cortisol levels, genetic biomarkers (e.g., apolipoprotein E4), acetylcholinesterase levels, and albumin levels. However, systemic stress can lead to nonspecific activation of the immune system, resulting in a decrease in lymphocyte count. Although the relationships between CRP, albumin, and lymphocyte count with POD have been individually investigated in the literature, no study has examined the combined effect of these three parameters. Based on this, we aimed to investigate whether the CRP-Albumin-Lymphocyte (CALLY) Index, a novel index not previously reported in the literature, is effective in predicting POD in geriatric patients with hip fractures. The CALLY Index is calculated using the formula: (Albumin × Lymphocyte) / (CRP × 10⁴). Aim/Hypothesis: H₀: The CALLY Index cannot predict the risk of postoperative delirium in geriatric patients undergoing hip fracture surgery. H₁: The CALLY Index can predict the risk of postoperative delirium in geriatric patients undergoing hip fracture surgery. Material-Methods: The following data will be recorded for each patient: * Demographic variables: age, sex, height, weight, and body mass index (BMI) * American Society of Anesthesiologists (ASA) physical status classification * Comorbidities and medication use * Smoking and alcohol consumption history * Preoperative laboratory parameters: obtained from the hospital information system for CALLY Index calculation * Perioperative variables: type and duration of anesthesia, duration of surgery, type of surgical procedure, estimated blood loss, blood product transfusion status, and occurrence of intraoperative adverse events * Postoperative data: * Ward of admission after surgery (orthopedic ward/intensive care unit) * Presence of delirium, assessed twice daily (morning and evening) for three days using DSM-5 criteria, starting in the post-anesthesia recovery unit * Occurrence of postoperative complications * Length of stay in the intensive care unit * Total hospital length of stay * Mortality status Patients aged 65 years and older who undergo surgery for femoral neck or intertrochanteric fractures will be included in the study. Patients with preoperative delirium, preoperative dementia, pathological or open fractures, systemic or localized infections in the fracture region during the preoperative period, or multiple trauma will be excluded. Additionally, those with a BMI \<18.5 or ≥35 chronic organ failure, or advanced-stage cancer will be excluded from the study.
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Researchers are evaluating a new formulation of ready-to-use therapeutic food (RUTF) that includes milk fat globule membrane (MFGM) to treat children aged 6 to 59 months with severe acute malnutrition (SAM) in Sierra Leone. The study aims to find out if MFGM-enhanced RUTF can improve neurodevelopment and reduce serious outcomes like death, hospitalization, or remaining severely malnourished compared to standard RUTF containing skim milk powder. This trial is a randomized, blinded, controlled clinical study involving 1600 children across 20 rural sites. Participants will be assigned to receive either MFGM-RUTF or standard RUTF, with both groups consuming 2 sachets daily for up to 12 weeks. Each sachet contains about 92 grams of therapeutic food providing roughly 1000 calories, protein, fat, and micronutrients. Along with RUTF, some children may receive medications such as amoxicillin and malaria chemoprophylaxis as part of their treatment. The treatment period includes fortnightly clinic visits for measurements and assessments. During the study, children will have their length, weight, arm circumference, and nutritional edema measured every two weeks while receiving treatment. Neurodevelopment will be assessed using the Malawi Developmental Assessment Tool (MDAT) at the end of treatment and again 6 months later. A subset of participants will provide blood and stool samples. Researchers will measure outcomes including neurodevelopment scores, survival, hospitalization, and nutritional recovery over periods ranging from 2 weeks to 7 months after treatment.
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This trial focuses on patients hospitalized with acute decompensation of chronic heart failure (CHF), who often experience worsening renal function (WRF) leading to resistance to diuretics and poor outcomes. Researchers are investigating if CHF patients with liver dysfunction, who produce less albumin, are more prone to WRF. The study evaluates whether adding intravenous human albumin to standard IV loop diuretics improves diuretic effectiveness and protects kidney function in these patients. Participants are randomly assigned to receive either a continuous slow intravenous infusion of human albumin combined with IV furosemide or IV furosemide alone. The human albumin infusion is adjusted based on urine output and starts within 30 minutes after randomization and within 2 hours of hospital admission. Both groups receive diuretics adjusted by body weight and urine output. The study treatment lasts for at least 72 hours. During the study, researchers will assess symptoms and changes in serum creatinine levels from baseline to 72 hours. Additional measures include patient-reported breathlessness, body weight changes, fluid loss, length of hospital stay, and a composite outcome of death, rehospitalization, treatment escalation, or emergency visits up to 180 days after discharge. Participants are closely monitored with laboratory and imaging tests to evaluate liver function and kidney status throughout the study period, which is expected to continue until December 2026.
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Researchers are investigating the impact of different rates of intraoperative fluid therapy (IFT) on microcirculation and hemodilution during elective recumbent and laparoscopic surgeries. IFT is used to optimize oxygen delivery to tissues during surgery, but the optimal fluid dosage remains unclear. Surgery can damage the endothelial glycocalyx (EG), a key structure affecting microcirculation and tissue metabolism, leading to plasma release and hemodilution. This study aims to understand how IFT affects microcirculation parameters and postoperative outcomes. The study compares several infusion rates of crystalloid solutions based on the type of surgery. For recumbent and laparoscopic surgeries, different infusion rates are given during the first 20 minutes followed by a reduced rate thereafter. The study includes experimental groups with 10%, 20%, and 30% hemodilution, as well as a standard care group. The fluid infusion is tailored by weight (ml/kg/h) and administered during surgery to observe its effects. Participants will undergo their planned surgery with assigned fluid infusion rates. Researchers will measure sublingual microcirculation profiles one hour after fluid administration as the primary outcome. The study monitors blood loss and hemodynamic stability during surgery. Participation involves elective surgery and fluid management with no masking or randomization. The trial started in October 2022 and is expected to end in December 2025.