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Sepsis clinical trials

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NCT ID: NCT06018792 Recruiting - Sepsis Clinical Trials

Molecular Culture for the Diagnosis of Pediatric Sepsis

CHAMPIONS
Start date: March 10, 2024
Phase:
Study type: Observational

Babies and children have an increased risk of getting an infection with a bacteria in the bloodstream (sepsis). It is often difficult for the doctor to determine whether a child has an infection of the bloodstream, because the symptoms are often unclear and can also occur in children who are not sick. To determine whether there is an infection, a little blood is currently taken for a blood test (the blood culture) to investigate whether there is a bacteria in the blood. However, it often takes at least 36 hours before the results of this blood culture are available. That is why antibiotics are usually started immediately to treat the possible infection. However, it often turns out that the blood culture is negative after 36 hours, which means that no bacteria have been found in the blood. Usually the antibiotics are then stopped because it turns out that there was no infection at all. There is currently no good test that can predict whether (newborn) children have an infection or not. That is why too many children are currently wrongly receiving antibiotics. These antibiotics can damage the healthy bacteria in the intestines. There are many billions of 'beneficial bacteria' in the intestine. These play an important role in the digestion of food and protect against external infections. Antibiotics aim to kill bacteria that cause inflammation or infection. Unfortunately, antibiotics also kill some of these beneficial bacteria. In addition, unnecessary use of antibiotics contributes to antibiotic resistance. The aim of this research is to investigate whether Molecular Culture, a PCR based test that can identify bacterial pathogens in bodily fluids within 4 hours, has greater accuracy than traditional culturing techniques for bacteria in blood. If proven, this could lead to faster identification or exclusion of sepsis in children.

NCT ID: NCT06014736 Active, not recruiting - Clinical trials for Staphylococcus Aureus Bloodstream Infection

A Phase I Study of XJ101 in Chinese Healthy Subjects

Start date: August 15, 2023
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-parallel intervention clinical study that will include approximately 38 healthy subjects based on inclusion and exclusion criteria. Subjects will be assigned to one of four different dosage cohorts. Subjects in each cohort will randomly be given experimental drug or a placebo.

NCT ID: NCT06013033 Not yet recruiting - Sepsis Clinical Trials

DDX17 Orchestrate Septic Vascular Endothelial Pyroptosis by Controlling Gasdermin D Pore Formation

Start date: September 1, 2023
Phase:
Study type: Observational

Objective: To investigate the correlation between plasma levels of DDX17 and GSDMD with vascular endothelial dysfunction and prognosis of in sepsis patients. Design: A single center, prospective, observational research. Participants: Patients with sepsis who are hospitalized to Southeast University Affiliated Zhongda Hospital and meet the diagnostic criteria for sepsis 3.0. Inclusion criteria:1. There is a potential or clear infection; 2. Sequential organ failure score (SOFA score) increases by more than or equal to 2 points compared to the baseline value; 3. Sign informed consent form. Exclusion criteria: Age<18 years old or>80 years old, pregnant women, tumor patients, including diseases that may be complicated with vascular endothelial damage: hypertension, acute and chronic hepatitis (hepatitis caused by virus), liver cirrhosis, PT prolongation after liver transplantation, acute myocardial infarction, chronic tubular nephritis, chronic renal insufficiency/maintenance hemodialysis, renal transplantation, interstitial pneumonia, acute pancreatitis, active phase of systemic lupus erythematosus Ulcerative colitis, Crohn's disease, HELLP syndrome. Primary outcome: 28-day mortality. Secondary outcome: Plasma levels of DDX17 and GSDMD, and their correlation with vascular endothelial injury, severity, and prognosis in sepsis patients.

NCT ID: NCT06010186 Recruiting - Sepsis Clinical Trials

Evolution of Muscle Function, Breathlessness and Quality of Life Following Intra or Extra-Abdominal Sepsis in ICU Patients

EMBLemAticS
Start date: July 28, 2023
Phase: N/A
Study type: Interventional

Sepsis is organ dysfunction secondary to an inappropriate host response to infection. In the most severe cases, circulatory failure necessitating the introduction of vasopressor therapy is called septic shock. Sepsis and septic shock are life-threatening systemic organ dysfunctions requiring hospitalization in a critical care unit. According to several studies, sepsis accounts for around 30% of patients in these units. In this patient population, mortality in the critical care unit or in hospital is 25.8% and 35.3% respectively. Among the organ dysfunctions associated with sepsis, striated skeletal muscle damage is frequent and possibly severe. The literature refers to this as sepsis-induced myopathy, and describes three main mechanisms: mitochondrial dysfunction, exacerbated proteolysis and altered muscle membrane excitability. Of all the striated skeletal muscles that can be affected, the diaphragm and the muscles of the thoracic and abdominal wall play a major role in breathing. The diaphragm remains the main muscle involved in breathing. Its physiology is twofold. Firstly, through its contraction, the diaphragm is responsible for the lateral movement of the lower ribs, thus increasing the transverse diameter of the thorax. This first action is commonly referred to as "insertional". At the same time, lowering the phrenic center of the diaphragm increases abdominal pressure. Its distinctive upwardly convex domed appearance means that it is intimately in contact with both the chest wall and the abdominal cavity. This particular area of contact is called the apposition zone. It is on this zone, under the action of the abdominal compartment, that positive pressure also generates an outward thrust from the medial face of the lower ribs, a second action commonly referred to as "appositional". A number of studies, including that carried out by our team (US_DIAMONDS, NCT 02474797), have identified a high prevalence of diaphragmatic damage in patients with sepsis or septic shock. This can be as high as 60%. This diaphragmatic dysfunction would then be associated with a higher mortality rate in hospital and at D90 of discharge. The clinical evolution of post-resuscitation patients remains a little-studied subject. However, patients may present muscle dysfunctions in the longer term after a stay in intensive care. In our study, we demonstrated that less than half of patients recovered from diaphragmatic dysfunction on discharge from the critical care unit. In addition, Borges RC et al. found a significant decrease in the cross-sectional area of the rectus femoris at discharge, compared with the same measurement taken at D+2 of admission to the critical care unit. Finally, the impact of muscle dysfunction on dyspnoea during sepsis and after its resolution is uncertain. Similarly, the impact of muscle dysfunction and dyspnoea on quality of life is unknown. Sepsis is associated with muscle dysfunction of multiple mechanisms. The aim of this study is to assess the immediate and longer-term impact of muscle dysfunction on muscle, dyspnea and quality of life in patients with abdominal sepsis ("Abdominal sepsis" group) and patients with extra-abdominal sepsis ("Extra-abdominal" group). Depending on the location of sepsis, this study will enable us to assess and potentially confirm the preferential effect of abdominal sepsis on diaphragm function.

NCT ID: NCT06009445 Recruiting - Sepsis Clinical Trials

Renal Resistive Index as a Predictor of Acute Kidney Injury and Evaluation of Fluid Administration in Sepsis

Start date: July 1, 2023
Phase:
Study type: Observational

We aim from this study to investigate the role of renal resistance index (RRI) in evaluation of Acute kidney injury development and fluid administration in sepsis patients considering the change in RRI values over 7 days from admission as a predictor of AKI development

NCT ID: NCT06008223 Completed - Sepsis Clinical Trials

Clinical Analysis of Vitamin B6 in Sepsis

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Methodology Patients A total of 128 patients with sepsis and AKI who were admitted to several centers including Huzhou first people's Hospital combined with Wuxing People's Hospital, Linghu people's Hospital and Nanxun people's Hospital from November 1, 2021 to October 31, 2022 were included in the study. And all patients were diagnosed by clinical examination, Diagnostic criteria sepsis was diagnosed according to the international Sepsis-3 for patients with suspected infection using the quickly Sepsis related organ failure assessment (qSOFA). The qSOFA score consists of only three criteria: Glasgow Coma Scale (GCS) <15, systolic blood pressure ≤ 100 mmHg, and respiratory rate ≥22/min. A qSOFA score of 2 or more points indicates suspected sepsis. Criteria for AKI was defined according to the Kidney Disease Improving Global Outcomes (KDIGO), by the presence of one of the following: ①Increase in SCr by ≥ 0.3mg/dl (≥26.5 μ mol/L) within 48h;② Renal impairment is known or increase in SCr by ≥50% within 7days; ③ Oliguria for ≥4 hours. All patients were authorized by their families to sign informed consent, and the study was approved by the ethics committee of the hospital. Inclusion criteria: ①18-65 years old; ② The hospital survival time was more than 48 hours, and the medical records were complete; ③There is no history of vitamin B6 use in the recent period of admission (within 2 weeks before admission). Exclusion criteria: ①Patients with chronic renal insufficiency or renal failure in the past; ②Related renal injury caused by reasons other than sepsis; ③At the time of admission to ICU, there was cardiac failure or cardiogenic shock in combination with sepsis; ④Patients who use nephrotoxic drugs or contrast agents; ⑤Previous kidney transplantation; ⑥Patients with restrictive use of positive inotropic drugs (such as left ventricular outflow tract stenosis); ⑦Age<18 or>65; ⑧pregnant woman. Treatment 128 patients were divided into experimental and control group by random number table method, 64 patients in each group. Both groups were given routine treatment of sepsis and corresponding treatment of primary disease. The Patients in experimental group were given vitamin B6 injection 300mg/d (100mg/2ml× 3) intravenous injection, the course of treatment is one week or until the patient dies. That in control group were injected with 0.9% sodium chloride solution 6 ml intravenously. Assessment The general clinical data of the two groups were recorded, including age, sex, acute physiology and chronic health status scoring system II (APACHE II), qSOFA, and the constituent ratio of primary disease before treatment. The inflammatory reaction indexes of the two groups were detected before and on the 7th day of treatment, including Interleukin 6 (IL-6), interleukin 8 (IL-8), tumor necrosis factor (TNF-α) and endothelin-1 (ET-1). After collecting 5ml of fasting elbow vein blood from two groups of patients, the serum was separated by centrifugation (centrifugation radius: 3cm, rotation speed: 2000r/min, time: 10min), and then detected by enzyme-linked immunosorbent assay (ELISA). ELISA kits for IL-6 (ab178013), IL-8 (ab214030), and TNF-a(ab181241) were purchased from abcam company. ELISA kit for ET-1 (K7429-100) was purchased from BioVision. All ELISA experiments were performed according to the kit instructions. The oxidative stress response indexs of the two groups were detected before and on the 7th day of treatment, including superoxide dismutase (SOD), glutathione (GSH), malondialdehyde (MDA). The xanthine oxidase method is used to detect SOD, the DTNB method is used to detect GSH, and the thiobarbituric acid method is used to detect MDA. The renal function indexs before and after treatment were detected before and on the 7th day of treatment, including the blood urea nitrogen (BUN) and serum creatinine (sCr) and renal resistance index (RRI). RRI was detected by ultrasound. And the clinical data, including the rate of renal replacement therapy, ICU length of stay, total hospitalization expenses, and 28-d mortality, were recorded. Statistical analysis All measurements were expressed as mean ± standard deviation (x ± s). And the counting datas were expressed in the form of percentage [n (%)]. The statistical SPSS 23.0 software were performed using the two samples t-test and adjusted chi-square test for the two groups. P-value,0.05 was considered to be statistically significant.

NCT ID: NCT06007352 Not yet recruiting - Sepsis Clinical Trials

Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis

Start date: May 2024
Phase: Phase 2
Study type: Interventional

The purpose of the study is to investigate whether the use of gentamicin-based irrigation fluid during ureteroscopy decreases the risk of UTIs and other post-operative infections after surgery.

NCT ID: NCT06006325 Recruiting - Sepsis Clinical Trials

Electroacupuncture Modulates SPMs Metabolism and Respiratory Symptoms in Patients With Sepsis Complicating ARDS

Start date: August 20, 2023
Phase: N/A
Study type: Interventional

In this interventional clinical trial, researchers will administer electroacupuncture versus sham electroacupuncture to sepsis patients with ARDS and collect objective outcome measures. The study will be divided into 2 groups. The EA group will receive electroacupuncture and the SHAM-EA group will receive sham electroacupuncture. The purpose of this study is to investigate the effect of electroacupuncture on the synthesis of SPMs in sepsis patients with ARDS.

NCT ID: NCT06002295 Completed - Neonatal Sepsis Clinical Trials

A Comparative Analysis of 4% Chlorhexidine Versus Methylated Spirit as Prophylaxis of Omphalitis and Sepsis in Newborns

Start date: September 12, 2020
Phase: Phase 2
Study type: Interventional

Introduction: Neonatal sepsis in one of the leading cause of death in developing countries. Umbilical cord care is important as it may lead to infection. Topical treatment can help to reduce the chances of infection as well as increase the chances of early removal. In this regard methylated spirit and chlorhexidine are found to be effective. Aims and Objectives: To compare the effectiveness of 4% chlorhexidine and methylated spirit in newborns for prevention of omphalitis and neonatal sepsis. Materials and Methods: This randomized control trial was carried out in neonatal unit of Shaikh Zayed Hospital Lahore. After meeting the inclusion criteria, 300 neonates were enrolled. In group A 4% chlorhexidine was applied for cord care and in group B methylated spirit was used. Neonates were followed till 10th day of life. Careful examination was done for cord separation and for any signs of omphalitis or sepsis. If the neonate had no signs and symptoms of omphalitis and sepsis on 10th day of follow up then it was treatment success.

NCT ID: NCT06001294 Recruiting - Sepsis Clinical Trials

We Collected Blood Samples From Septic Shock Patients and Measured ELABELA, Creatinine, and NGAL Levels. Survival After 7 Days Was Recorded and Analyzed to Evaluate the Potential of Serum ELABELA as an Early Diagnostic Marker for Sepsis-associated Acute Kidney Injury.

ELABELA(ELA)
Start date: July 3, 2022
Phase:
Study type: Observational

The investigators selected patients diagnosed with sepsis who were admitted to the Intensive Care Unit (ICU) of Huai'an First People's Hospital between June 2022 and December 2023, as well as healthy individuals with normal kidney function during the same period, for the research. The investigators collected blood samples from patients with septic shock or sepsis at 6 hours, 12 hours, 24 hours, 48 hours, 3 days, 5 days, and 7 days after diagnosis, and also collected blood samples from the healthy individuals. The blood samples were stored in gel separation vacuum tubes containing heparin as an anticoagulant. The supernatant was removed and stored at -80°C, and the levels of plasma ELA (enzyme-linked immunosorbent assay) were measured using a standardized ELA kit. Additionally, serum NGAL (neutrophil gelatinase-associated lipocalin) and creatinine levels were measured simultaneously. The subjects were divided into three groups based on the KDIGO diagnostic criteria: sepsis-associated acute kidney injury (S-AKI) group, sepsis non-AKI group, and normal control group. Finally, the data were analyzed to determine the early diagnostic value of ELA for S-AKI. Approximately 70 specimens were collected in total.