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Toxemia clinical trials

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NCT ID: NCT03644940 Withdrawn - Sepsis Clinical Trials

Subpopulation-Specific Sepsis Identification Using Machine Learning

Start date: December 2020
Phase: Phase 2
Study type: Interventional

The focus of this study will be to conduct a prospective, randomized controlled trial (RCT) at Cape Regional Medical Center (CRMC), Oroville Hospital (OH), and UCSF Medical Center (UCSF) in which a subpopulation-optimized algorithm will be applied to EHR data for the detection of severe sepsis. For patients determined to have a high risk of severe sepsis, the algorithm will generate automated voice, telephone notification to nursing staff at CRMC, OH, and UCSF. The algorithm's performance will be measured by analysis of the primary endpoint, in-hospital SIRS-based mortality. The secondary endpoints will be in-hospital severe sepsis/shock-coded mortality, SIRS-based hospital length of stay, and severe sepsis/shock-coded hospital length of stay.

NCT ID: NCT03517501 Withdrawn - Clinical trials for Sepsis and Coagulopathy

The Safety And Efficacy of ART-123 in Subjects With Sepsis and Coagulopathy

Scarlet2
Start date: July 2019
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality.

NCT ID: NCT03090919 Withdrawn - Sepsis Clinical Trials

The INFUSE Trial - Intervening With Platelet Transfusions in Sepsis

INFUSE
Start date: January 3, 2017
Phase: N/A
Study type: Interventional

Sepsis is life-threatening and dysregulated response to infection that results in endothelial activation and dysfunction that leads to systemic microvascular leak and multiple-organ failure. This study will identify patients that have sepsis with thrombocytopenia and randomize them to receive a unit of platelets or an equivalent volume of saline.

NCT ID: NCT02886910 Withdrawn - Chorioamnionitis Clinical Trials

Chorioamnionitis: Observation of at Risk Infants vs Standard Care

CHORIS-RCT
Start date: October 2016
Phase: N/A
Study type: Interventional

This study evaluates the non-inferiority of a protocol of limited evaluation (complete blood count, blood culture) and clinical observation by standardized physical examination versus the algorithm suggested in the CDC's 2010 guidelines (limited evaluation, clinical observation and antibiotic therapy) in the management of asymptomatic infants born at term to mothers with suspected chorioamnionitis. The primary outcome of the study is the difference in the prevalence of sepsis-related symptoms between the two groups.

NCT ID: NCT02699905 Withdrawn - Sepsis Clinical Trials

Neutrophil FFA2/GPR43 Receptor Expression in Patients With the Diagnosis of Sepsis

GPR43Sepsis
Start date: August 2016
Phase: N/A
Study type: Observational

This study seeks to elucidate the quantitative expression of G - protein receptor 43/free fatty acid (GPR43/FFA2) receptors in patients with the diagnosis of sepsis and specifically, its expression as it relates to the severity of sepsis. The investigators hypothesize that patients with more severe sepsis, as defined by a higher SOFA (Sequential Organ Failure Assessment Score), will have decreased expression of the GPR43/FFA2 as compared to patients with lower SOFA scores, consistent with a less exuberant immune response to infection. Patients admitted to Penn State Hershey Medical Center with a diagnosis of sepsis of any cause will undergo blood testing of leukocytes to determine the expressed quantity of GP43 during standardized time points of their illness and recovery. No interventions will be made in the standard clinical management of the patient. Additionally, healthy volunteers will be recruited to exam baseline GPR43 receptor expression between sepsis and control groups.

NCT ID: NCT02684487 Withdrawn - Sepsis Clinical Trials

Vitamin D Status in Patients With Severe Sepsis

ViDISS
Start date: December 2017
Phase: Phase 3
Study type: Interventional

Sepsis is a clinical entity that complicates infection. Without early recognition and timely management, it can rapidly progress to severe sepsis, septic shock, and culminate in multiple organ dysfunction syndrome. Forty to 70% of septic patients have low vitamin D status, yet little is known about the impact of vitamin D3 (vitD3) supplementation in this patient population. As such, the investigators propose a randomized, double-blinded, placebo-controlled trial to test the hypothesis that early, rapid correction of low vitamin D status, as an adjunct to established treatment guidelines, will improve clinical outcomes and measurably alter immune profile in patients with severe sepsis.

NCT ID: NCT02319265 Withdrawn - Sepsis Clinical Trials

Dose Assessment of Melatonin in Sepsis Trial

DAMSEL2
Start date: April 2017
Phase: Phase 1/Phase 2
Study type: Interventional

DAMSEL 2 is a pilot Phase II study in patients with sepsis. Stage 1 will assess the pharmacokinetics of melatonin and its major metabolite after a single dose of 50 or 100mg exogenous melatonin in two small groups of patients with sepsis in order to make dosing and dosing interval decisions for Stage 2. Stage 2 is a double blind randomised controlled trial of melatonin in patients with sepsis at the dose and dosing interval decided after Stage 1. Measurements of melatonin and its major metabolite, and an array of biomarkers of inflammation and oxidative stress will be made, plus transcriptome (mRNA) analysis. This study will inform a planned larger phase II trial.

NCT ID: NCT02266654 Withdrawn - Sepsis Clinical Trials

Early Goal Directed Therapy in Sepsis by Emergency Medical Services

Start date: October 2014
Phase: N/A
Study type: Interventional

The goal is to evaluate the best way for paramedics and hospitals to work together to treat septic patients as quickly as possible. The investigators think that the best thing to do for septic patients is to identify and treat them as early as possible. This research will test this. The investigators think that if paramedics identify septic patients and begin treatment with fluids in the ambulance, then the patient will do better in the long run. The paramedic will also tell the hospital that a septic patient will be there soon. The caregivers can prepare and be ready to provide care as soon as the patient arrives. With this research, the investigators would like to see if these steps help patient outcomes.

NCT ID: NCT01926301 Withdrawn - Septic Shock Clinical Trials

Cerebrovascular Autoregulation in Sepsis, Influence of Renal Replacement Therapy

SepsAR2
Start date: August 2013
Phase:
Study type: Observational

The cerebrovascular autoregulation is impaired in patients with severe sepsis and septic shock. A continuous veno-venous hemodialysis may improve impaired cerebrovascular autoregulation. Hypothesis: continuous hemodialysis recovers impaired cerebrovascular autoregulation in patients with acute severe sepsis and septic shock.

NCT ID: NCT01825421 Withdrawn - Clinical trials for Neonatal Late-onset Sepsis

A Pilot Randomized Controlled Trial for Antibiotic Exposure in Neonatal Sepsis Using Neutrophil CD64

Start date: October 2014
Phase: N/A
Study type: Interventional

Unnecessary and prolonged antibiotic therapy in newborn babies can have serious consequences including development of necrotizing enterocolitis (a serious, potentially life-threatening gastrointestinal illness in premature babies), late-onset infections, resistance to antibiotics, increased length of hospital stay, and death. Starting and continuing antibiotic therapy for blood culture-negative infections in the neonatal intensive care unit (NICU) is fairly common with numbers of such patients varying from 20%-90% of infants undergoing a sepsis evaluation in the NICU. While blood culture results are the gold standard, there is usually a delay of up to 48-72h before the results are known. Hence, initiation and continuation of antibiotic treatment are usually based on clinical evaluation and blood count criteria which do not possess high specificity or sensitivity, and may be unreliable in the first few hours after birth or in the early stages of infection. Since the investigators found that neutrophil CD64 (a type of protein found on the surface of a type of white blood cell that can be detected quickly in a very small amount of blood sample) has high accuracy for early detection of blood culture-proven infections in newborn babies, with extremely high negative predictive value (can identify babies definitively with no infection), the investigators will use this test to decide whether to stop or continue antibiotics in the NICU. The investigators hypothesis is that neutrophil CD64 values can be safely used to discontinue antibiotics in newborns suspected of having infections. The investigators aims are to utilize sequential measurements of CD64 values to stop antibiotics early in neonates being investigated for both early and late-onset infections in the NICU. This is a prospective, randomized, controlled (RCT) trial. The study population will be derived from the sub-set of all newborn infants who have undergone investigations for presence of infection in the NICU.