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NCT ID: NCT04565691 Recruiting - Sepsis Clinical Trials

Bacteremia From Periodontal Treatment to Elucidate the Underpinnings of Sepsis

Start date: February 25, 2019
Phase: N/A
Study type: Interventional

Approximately 40,000 Swedes suffer from sepsiseach year, about 20% die. Biomarkers that are sensitive to current or previous bacteremia are needed in the treatment of sepsis. Bacteremia from periodontal treatment is predictive and occurs in 13-75%. Cardiovascular disease (CVD) is the number one cause of death in industrialized countries and the impact of bacteria and their products need to be elucidated. The study's hypothesis is to utilize bacteremia from periodontal treatment to evaluate biological markers for current or previous bacteremia. A. What are the long term clinical, and 'omics related CVD-phenotypical effects from treating periodontal disease compared to an untreated group? B. Can biomarkers be used for detecting a bacteremia or previous bacteremia? C. Are the effects from bacteremia on cardiovascular biomarkers related to the individual's antimicrobial peptide profile? D. Does the presence of bacterial proteases, such as gingipain, relate to having a bacteremia from periodontal treatment and the systemic response from a bacteremia? Significance: The project has the potential to shorten the time to treat sepsis, which in turn shortens hospital stay and higher survival. The possible definition of protective AMP-profile could translate to future pharmacologic intervention and improve the treatment of sepsis as well as prophylactic treatment at dental treatments. An elucidation of the impact of bacteria and their products on CVD could lead to personalized medicine targeting anti-inflammation and anti-oxidative stress in subjects with periodontitis. As of March 2024 78 subjects have been included and we anticipate to keep the time-line that we set up.

NCT ID: NCT04541264 Recruiting - Clinical trials for Early Prediction for Sepsis Induced Acute Lung Injury

Radiomics Markers to Predict Sepsis Induced Acute Respiratory Distress Syndrome

Start date: June 1, 2021
Phase:
Study type: Observational

Introduction: Sepsis-induced acute respiratory distress syndrome(SI-ARDS) is a common complication of severe sepsis and is an independent contributor to poor prognosis of patients. It remains a clinical challenge to identify the SI-ARDS early and accurately, which could optimize the treatment strategy and reduce the mortality risk. Radiomics high-dimensional features extracted from CT images offer an insight into microvascular damage of SI-ARDS that are imperceptible to human eyes and aspects of intra-alveolar heterogeneity with potential prognostic relevance. Methods: Study design Investigators screened all patients with sepsis and septic shock who are treated in Sun Yat-sen Memorial Hospital, Sun Yat-sen University during the period from 1 May 2015 and 30 May 2022. Patients were recruited retrospectively from May 2015 to April 2021 as discovering group, and prospectively during the period from May 2021 to May 2022 as validation group. Follow-up will conducted until April 2023. Cohort descriptions and definitions Investigators plan to recruit 160 patients in discovering group, 40 patients in internal validation group, and 100 patients in external validation group. Patients between 18 and 80 years of age with sepsis and septic shock will be screened for eligibility. SI-ARDS is defined by sequential occurrence of the sepsis-3 consensus criteria for sepsis and the Berlin Definition for ARDS. The exclusion criteria are: 1. admission stay <24hours, 2. the presence of end-stage lung disease or long-term oxygen therapy, 3. critically ill patients who have started mechanical ventilation caused by SI-ARDS before admission, 4. a history of lung transplantation and chronic obstructive pulmonary disease, 5. cancer patients not/have received chemotherapy. Outcome measures In this study, the primary outcome measure was the occurrence rates of acute respiratory distress syndrome(ARDS). It refers to the occurrence of sepsis patients progressed into ARDS. Secondary outcome measures were as follows: 1.28-day mortality 2.ventilator-free days 3.respiratory failure-free days Data collection All clinical data were collected by investigators and trained personnel. Each participant's data will be filled in electronic case report forms (CRF) and store online using REDCap (Research Electronic Data Capture). Discussion: SI-ARDS is one common severe complication with critically ill sepsis patients, which causes high mortality and poor prognosis. Early ARDS patient(arterial oxygen tension/inspired oxygen fraction [PaO2/FIO2] ≤ 300 mmHg but > 200 mmHg) may not require invasive mechanical ventilation, and is more readily reversible than acute respiratory distress syndrome(ARDS). In this ambispecive cohort study, investigators developed and validated novel nomograms incorporating the radiomics signature and clinical signature to provide an easy-to-use and individualized prediction of SI-ARDS occurrence and severe degree in patients with early stage.

NCT ID: NCT04529655 Recruiting - Sepsis Clinical Trials

Digital Capillary Refill for Monitoring of Sepsis

Start date: August 12, 2020
Phase:
Study type: Observational

Observational study for monitoring of capillary refill time in sepsis

NCT ID: NCT04525677 Recruiting - Sepsis Clinical Trials

Gut Microbiome Dysbiosis in Sepsis-induced Coagulopathy

Start date: July 15, 2020
Phase:
Study type: Observational

In the diagnosis and treatment of patients with sepsis, through routine stool testing and dynamic testing of coagulation function, we found that patients often have stools that are not formed, the proportion of main fecal bacteria is imbalanced, the level of blood bacterial toxins rises, and the abnormal coagulation status indicate the gut microbiome dysbiosis may play an important regulatory role in abnormal blood coagulation in patients with sepsis. Therefore, we propose that the gut microbiome dysbiosis is involved in sepsis-induced coagulopathy. This project intends to prospectively observe the changes in gut microbiome dysbiosis and blood coagulation function in patients with sepsis before and after treatment, and explore whether the changes in gut microbiome dysbiosis promote the development of sepsis through coagulation disorders, provide new research perspectives for diagnosis and treatment for sepsis.

NCT ID: NCT04513288 Recruiting - Sepsis Clinical Trials

ICITRU : Randomized Trial of Immunonutrition With L-citrulline in Patients Hospitalized in Intensive Care for Sepsis or Septic Shock

ICITRU
Start date: May 20, 2022
Phase: N/A
Study type: Interventional

Immunonutrition in intensive care has not yet demonstrated a beneficial effect on organ failure, the acquisition of nosocomial infections, or mortality. It did not correct for acquired immunosuppression in intensive care patients. Despite numerous methodological problems (use of several pharmaconutrients, very heterogeneous set of patients) and the absence of clinical data, deleterious effects have been attributed to immunonutrition in intensive care, in particular in septic patients and patients in intensive care . Arginine (ARG) is a semi-essential amino acid involved in many immunological mechanisms. It is synthesized in sufficient quantity under normal conditions but quickly becomes insufficient under catabolic conditions such as in severe sepsis. Arginine is not only the precursor of nitrogen monoxide (NO) but also an essential substrate for numerous enzymatic reactions which participate in the maintenance of immune homeostasis, in particular T lymphocyte function. Depletion of the cellular medium in arginine will induce an abnormality in the metabolism of immune cells responsible for a dysfunction of these cells (lymphopenia linked to early apoptosis) and thus expose patients to organ failure and nosocomial infections. It has been found that hypoargininemia in intensive care patients is associated with the persistence of organ dysfunction (SOFA score), the occurrence of nosocomial infections and mortality. Also, it has been demonstrated that in these patients, enteral administration of ARG was not deleterious and increased ornithine synthesis, suggesting a preferential use of ARG via the arginases route, without significant increase in argininaemia or effect on immune functions. L-citrulline (CIT), an endogenous precursor of ARG, constitutes an interesting alternative for increasing the availability of ARG. Sponsor recent data demonstrate that the administration of CIT in intensive care is not deleterious and that it very significantly reduces mortality in an animal model of sepsis, corrects hypoargininemia, with convincing data on immunological parameters such as lymphopenia, which is associated with mortality, organ dysfunction and the occurrence of nosocomial infections. The availability of ARG directly impacts the mitochondrial metabolism of T lymphocytes and their function. Our hypothesis is therefore that CIT supplementation is more effective than administration of ARG in correcting hypoargininemia, reducing lymphocyte dysfunction, correcting immunosuppression and organ dysfunction in septic patients admitted to intensive care.

NCT ID: NCT04448951 Recruiting - Sepsis Clinical Trials

Immune Homeostasis in Sepsis and Septic Shock

IMHOTEP
Start date: September 1, 2020
Phase:
Study type: Observational [Patient Registry]

Detailed description of immune response and its dynamics in sepsis and septic shock patiens by means of transcriptomics, flow-cytometry and cytokine analysis.

NCT ID: NCT04322942 Recruiting - Sepsis Clinical Trials

Sepsis Prediction by Monocyte Distribution Width and Procalcitonin

Start date: April 16, 2019
Phase:
Study type: Observational

The mortality rate of sepsis remains as high as 30 to 40%. Early diagnosis and treatment of patients with sepsis reduce mortality significantly. The most commonly used biomarkers in clinical practice are C-reactive protein (CRP) and procalcitonin (PCT). In terms of exploring new diagnostic tools of sepsis, monocyte distribution width (MDW) was first reported in 2017. It was reported as part of the white blood cell (WBC) differential count. MDW greater than 20 and abnormal WBC count together were reported to provide a satisfactory accuracy. The area under curve (AUC) in predicting sepsis-2 is 0.852. It was proposed as a novel diagnostic tool of sepsis in the emergency setting. Nonetheless, the performance of MDW compared with the conventional biomarkers remained unknown. The aim of this study was to compare the diagnostic accuracy of MDW and PCT on sepsis in the emergency department.

NCT ID: NCT04306419 Recruiting - Sepsis Clinical Trials

Observational Trial on Cytokine Adsorption in Sepsis

OuTCASt
Start date: November 15, 2020
Phase:
Study type: Observational

To determine the specific population of critically ill septic patients who benefit most from cytokine adsorption therapy with the HA-380 cartridge. Benefit of the treatment will be assessed on the basis of: - The scope of the effect of cytokine adsorption therapy in this specific population of critically ill patients expressed by cytokine variability within the patients - The scope of cytokine changes in passing the adsorption cartridge my measuring cytokine levels in the patient's blood directly before passing through the cartridge and directly after having passed through the cartridge. - The scope of changes in organ dysfunction expressed by SOFA scores that are repeatedly calculated during the treatment with cytokine adsorption and then daily until day 7 of the ICU treatment. - The scope of changes on cellular function on immune cells in serum samples taken before and after cytokine adsorption therapy. - The scope of removal of anti-infective drugs from the blood in passing through the cytokine adsorption cartridge by measuring antibiotic drug levels in the patients blood during the cytokine adsorption therapy - 30 day and 90 day mortality and location status in survivors

NCT ID: NCT04289506 Recruiting - Sepsis Clinical Trials

Validation of Molecular and Protein Biomarkers in Sepsis

VAMp-sepsis
Start date: February 25, 2020
Phase:
Study type: Observational

Background: Sepsis (blood poisoning) is a clinical syndrome characterised by a dysregulated host response to infection causing life-threatening organ dysfunction which results in admission to an intensive care unit. It typically shows an initial harmful inflammation resulting from the immune system's overreaction to a severe infection. It is a major healthcare problem, affecting millions of people worldwide. In the UK, it kills over 37,000 people/year, costing the NHS £2.5 billion a year, and is increasing in incidence. Despite extensive efforts to tackle this burden, at present, however, there are no specific and effective therapies for this illness. Sepsis is a potentially life-threatening condition caused by a severe infection. When someone develops sepsis, inflammation occurs not just at the site of the infection but throughout the whole body. This widespread inflammation can be very harmful. It is known that similar responses occur in other conditions, not relating to infection. The investigators are recruiting patients with severe infections causing organ failure (also known as severe sepsis/ septicaemia and septic shock) and also patients where widespread inflammation, not related to infection, causes organ failure. In this study the investigators hope to find out whether certain groups of genetic and blood based protein markers of sepsis can forewarn the clinicians to this condition and also highlight patients who are responding well to the treatment. Although it is known that the majority of the patients suffering from sepsis will survive their ICU stay and leave the hospital alive, there is insufficient data how these patients do on a longer term, i.e. after some time at home. To date there is little information on the ability of the observed genetic and blood based protein markers to predict the functional status of the patients surviving these conditions.

NCT ID: NCT04280497 Recruiting - Sepsis Clinical Trials

Rapid Recognition of Corticosteroid Resistant or Sensitive Sepsis

RECORDS
Start date: April 10, 2020
Phase: N/A
Study type: Interventional

Main objective and primary endpoint: To compare the effect hydrocortisone plus fludrocortisone vs. placebo on a composite of death or persistent organ dysfunction - defined as continued dependency on mechanical ventilation, new renal replacement therapy, or vasopressors - assessed at 90 days on intensive care unit (ICU) adults and having different biological profiles for immune responses and corticosteroids bioactivity. Secondary objectives and endpoints: - Mortality and health-related quality of life at 6 months; - Daily organ function (SOFA score days 1, 2, 3, 4, 7, 10, 14, 28, and 90); - Daily secondary infections (up to 90 days) - Daily blood and urinary levels of glucose, sodium and potassium (up to 28 day) - Daily gastroduodenal bleeding (up to 28 day) - Daily cognitive function and muscles' strength (days 1 to 28, 90 and 180 days).