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Sepsis clinical trials

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NCT ID: NCT04353388 Completed - Sepsis Clinical Trials

Sepsis Post Market Observational Study and Potential Reduction of Time to Antibiotics - Washington University

Start date: February 3, 2020
Phase:
Study type: Observational

The purpose of this study is to demonstrate that addition of the Monocyte Width Distribution (MDW) parameter to current standard of care improves a clinician's ability to recognize sepsis in the Emergency Department, resulting in earlier decision to administer antibiotics from time of ED presentation for sepsis patients (simulated primary endpoint), with concomitant reductions in length of stay and in-hospital mortality for those patients (secondary endpoints).

NCT ID: NCT04335955 Completed - Sepsis Clinical Trials

Platelet Indices in Prediction of Mortality in Critically Ill Septic Patients

Start date: May 1, 2020
Phase:
Study type: Observational

Platelets (PLT), a major and essential constituent of blood, plays an important role in physiological and pathological processes such as coagulation, thrombosis, inflammation and maintenance of vascular endothelial cells the integrity (1). Platelet indices are a group of parameters that are used to measure the total amount of PLTs, PLTs morphology and proliferation kinetics (2). The commonly used PLT indices include PLT count, mean platelet volume (MPV), platelet distribution width (PDW), and plateletcrit (PCT). The MPV refers to the ratio of PCT to PLT count. PDW is numerically equal to the coefficient of PLT volume variation, which is used to describe the dispersion of PLTs volume (3). It is well known that platelet indices have been applied in the diagnosis of hematological system diseases. In recent years, it has been discovered that these indices are related to the severity of illness and patients' prognosis. Reduction in PLT count is an independent risk factor for critically ill patients in intensive care unit (4). In addition, Acute Physiology and Chronic Health Evaluation II (APACHE II) System also includes thrombocytopenia as an independent risk factor for mortality (5). In a recent research, it will be reported that MPV will be rising with interleukin-6 and C-reactive protein in septic premature infants. MPV has been used as predictor of many inflammatory diseases as MPV significantly higher on both day 1 and day 3 in neonatal sepsis (6). In addition, in patients with cirrhosis and ascites, elevated PDW and MPV will be accurate diagnostic predictors for ascetic fluid infection (7). MPV and PDW will be used as biomarkers predicting the development of postoperative sepsis in colorectal cancer patient (8). All these evidences indicated that PLT indices will be considered as indicator in a series of diseases (9). Advantages of platelet indices are simple, available, cheap tools and routinely done in the hospital laboratory in all critical ill patients and may be a useful, sensitive tool for diagnosis and monitoring these patients especially in limited resource countries as Egypt. However, whether PLT indices are correlated with procalcitonin in assessment the severity of illness is still under research in septic patients

NCT ID: NCT04335539 Completed - Sepsis Clinical Trials

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants

Start date: August 21, 2020
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are: - To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed aerobic Gram-negative bacterial infections - To assess the pharmacokinetics (PK) of cefiderocol after single-dose administration of cefiderocol in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed aerobic Gram-negative bacterial infections - To assess the safety and tolerability of cefiderocol after multiple-dose administration in hospitalized paediatric participants 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections - To assess the PK of cefiderocol after multiple-dose administration in hospitalized paediatric participants 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections

NCT ID: NCT04332861 Completed - Sepsis Clinical Trials

Evaluation of Infection in Obstructing Urolithiasis

eIOU
Start date: September 3, 2019
Phase:
Study type: Observational

Obstructing urolithiasis can be life-threatening in the setting of urinary tract infection. The purpose of this study is to identify and validate risk factors and markers for the presence of infection and development of sepsis among patients with obstructing urolithiasis.

NCT ID: NCT04313790 Completed - Sepsis Clinical Trials

Assessment of the Anti-inflammatory Effect of Heparin Infusion Versus Subcutaneous Injection in Septic Patients

Start date: August 29, 2020
Phase: Phase 2
Study type: Interventional

Venous thromboembolism (VTE), including pulmonary embolism (PE) and deep venous thrombosis (DVT), is a common and severe complication of critical illness. Critically ill patients are at high risk of VTE because they combine both general risk factors together with specific ICU risk factors of VTE. Vasopressor administration was found to be an independent risk factor for DVT. certainly explained by reduced absorption of subcutaneous heparin linked to the vasoconstriction of peripheral blood vessels. For critically ill patients, due to the altered pharmacokinetics behavior of unfractionated heparin, continuous intravenous infusion of the low doses of unfractionated heparin has been proposed. Standard prophylaxis with subcutaneous (SC) heparin is less efficient in patients requiring vasopressors. Sepsis is a systemic inflammatory response due to an infection. Both inflammatory mediators and coagulation are involved in sepsis. the release of inflammatory mediators such as interleukins and tumor necrosis factor causes damage to the endothelium and activation of coagulation which promotes the inflammatory process. Unfractionated heparin is the most negatively charged biological molecule known, heparin has a strong ability to interfere with the functioning of positively charged molecules. Due to the difference in charges, heparin has been documented to interact with over 100 proteins.57 Interleukins, cytokines, and receptors located on endothelial cells, which are involved in the acute phase response, are positively charged and thus are a reasonable target for the modulating effects of heparin. Heparin has strong anti-inflammatory effects with many possible mechanisms, including binding to cell-surface glycosaminoglycans, preventing leukocyte migration, direct binding to chemokines and cytokines, and inhibition of intracellular NF-kB.

NCT ID: NCT04304235 Completed - Sepsis Clinical Trials

Paediatric Rapid Sepsis Trigger (PRST) Tool

PRST
Start date: April 27, 2020
Phase: N/A
Study type: Interventional

Sepsis is the leading cause of death and disability in children, every hour of delay in treatment is associated with greater organ damage and ultimately death. The challenges, especially in poor countries, are the delays in diagnosis and the inability to identify children in urgent need of treatment.To circumvent these challenges, we propose the development and clinical evaluation of a trigger tool that will reduce the time to diagnosis and prompt the timely initiation of life-saving treatment. The key innovations are 1) a data-driven approach to rapid diagnosis of sepsis severity and 2) a low- cost digital tagging system to track the time to treatment. The tool will require minimal cost, clinical expertise and training or time to use. The tool will identify high risk children and reduce time to treatment. The digital platform (mobile device and dashboard) will create a low-cost, highly scalable solution for children with sepsis.

NCT ID: NCT04292431 Completed - Sepsis Clinical Trials

Leukocyte MOrphology and CORticosteroids Response in SEPtic Patients (MOCORSEP)

MOCORSEP
Start date: November 1, 2019
Phase:
Study type: Observational [Patient Registry]

Non-interventional, prospective, monocentric study on the exploration of leukocyte morphological parameters according to the infectious condition and response to corticosteroid therapy of septic patients.

NCT ID: NCT04291508 Completed - Sepsis Clinical Trials

Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery

ASTER
Start date: October 13, 2021
Phase: Phase 2
Study type: Interventional

Prospective multi-center phase 2b randomized placebo-controlled double-blinded interventional platform trial of two different pharmacologic therapies (intravenous Vitamin C or intravenous Acetaminophen) for patients with sepsis-induced hypotension or respiratory failure.

NCT ID: NCT04291417 Completed - Sepsis Clinical Trials

Sepsis Post Market Observational Study and Potential Reduction of Time to Antibiotics - Baylor S&W

Start date: November 20, 2019
Phase:
Study type: Observational

The purpose of this study is to demonstrate that addition of the Monocyte Width Distribution (MDW) parameter to current standard of care improves a clinician's ability to recognize sepsis in the Emergency Department, resulting in earlier decision to administer antibiotics from time of ED presentation for sepsis patients (simulated primary endpoint), with concomitant reductions in length of stay and in-hospital mortality for those patients (secondary endpoints).

NCT ID: NCT04289688 Completed - Clinical trials for Health Care Utilization

Health Itinerary of Young Children With Suspected Bloodstream Infection in Kisantu General Referral Hospital, DR Congo

HIT BSI
Start date: February 1, 2021
Phase:
Study type: Observational

Bloodstream infections are frequent in children admitted to the hospital for severe febrile illness in sub-Saharan Africa.Ongoing blood culture surveillance at Kisantu Hospital showed non-typhoidal Salmonella (NTS) as the first cause of bloodstream infections in children. Bloodstream infections have a high case fatality (15 - 20%). Outcome of bloodstream infections is dependent on timely diagnosis and treatment. However, observations at Kisantu Hospital showed that many children arrive late and die early after admission. By interviewing caregivers of severely ill children admitted to Kisantu Hospital, the investigators aim to study their health itinerary, i.e. the sequence of all actions of health care seeking and care provision between the onset of febrile illness and the admission at the hospital. The investigators aim to assess the health itinerary according to the "three delays" model. The three delays model studies delays and practices at the level of health care seeking, of transport and of start of antibiotic treatment.10 Visits to referring health centers will provide complementary information about diagnosis, treatment and referral practices. In hospital follow-up will allow to assess the outcome according to the duration of health itinerary. The results of routine laboratory tests upon hospital admission will allow to stratify the health itinerary according to fever etiology. The results of this study will allow to understand the duration of the health itinerary, its possible association with case-fatality, and factors explaining for delays at every level. This information is expected to orient local health policy makers towards interventions shortening the duration of the health itinerary and in that case improve and monitor the referral system. In addition, the study results are expected to orient towards further research to understand health seeking behavior (i.e. focus-group discussions and community-based studies).