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Toxemia clinical trials

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NCT ID: NCT02562261 Completed - Sepsis Syndrome Clinical Trials

Platelet REactivity in Sepsis Syndrome (PRESS)

PRESS
Start date: January 2015
Phase:
Study type: Observational

Activation of blood platelets is a typical finding in patients with systemic inflammation and sepsis.They seem to mediate key pro-inflammatory mediator secretion, immune-cell activation while their adhesion to the endothelium enhances the pro-coagulatory activity of endothelial cells impairing microcirculation thus, may lead to multiple organ dysfunction. However, the exact effects of bacterial products on platelet function have not been found to be consistent and may vary according to the species, the timing of the study, and the pathogenesis of sepsis. Data vary, including both increased and decreased platelet reactivity and aggregation among patients with sepsis compared to healthy controls. Defining platelet's behaviour during sepsis is particularly important in view of recent findings revealing potential association between antiplatelet therapy and reduction in short term mortality, incidence of acute lung injury and intensive care unit admission in critically ill patients.This study aims to measure P2Y12 mediated platelet reactivity, -using the point-of-care P2Y12 VerifyNow assay, in platelet reactivity units (PRU)- along different stages of sepsis, including bacteremia/uncomplicated infection, sepsis, severe sepsis and septic shock. Subgroup follow up of patients going along different stages will also be performed. At the end of this study analysis of clinical and laboratory findings in correlation with platelet reactivity will be performed to assess platelet aggregation during sepsis.

NCT ID: NCT02544490 Completed - Sepsis Clinical Trials

Defining Circulating Micro-RNA Biomarkers for the Early Diagnosis and Prognosis of Sepsis

miRNA-Sepsis
Start date: September 2013
Phase:
Study type: Observational

The objectives are to: 1. derive and validate a panel of miRNAs that are consistently differentially expressed in the plasma of patients with and without sepsis 2. investigate the prognostic and predictive values of the panel of miRNAs to guide treatment 3. investigate the roles of these differentially-expressed circulating miRNAs in immune modulation during sepsis The methodology involves sampling of blood from controls and subjects in the sepsis continuum at their earliest presentation in the emergency department longitudinally to hospitalization. The investigators will develop panels of miRNAs that are specific to early and late stages of sepsis, and correlate clinical, biochemical and microbiological outcomes with these miRNAs.

NCT ID: NCT02539147 Completed - Severe Sepsis Clinical Trials

Characterization of Non-canonical Way in Inflammasome Monocytes of Patients With Severe Sepsis

CASPASEs
Start date: September 2014
Phase: N/A
Study type: Observational

Activation of caspase-4 and human caspase-5 (orthologs of caspase-11 in mice) in innate immune cells.

NCT ID: NCT02533011 Completed - Sepsis Clinical Trials

Evaluation of the Heparin Binding Protein Levels in Sepsis

HBP
Start date: July 2015
Phase: N/A
Study type: Observational

Present criteria used to define sepsis are non-specific, making it difficult to both distinguish sepsis from other diseases and to predict which patients are likely to become more severely ill. In standard care, patients at risk of becoming more severely ill are neither identified nor indicated for resuscitative efforts until they develop hemodynamic insufficiency or organ failure; after progression to severe disease, mortality increases significantly. The identification of risk patients can lead to earlier initiation of resuscitation therapies and potentially lead to reduced morbidity and mortality. This study aims to determine whether Heparin-binding protein (HBP), which is secreted from neutrophils during infection and a mediator of vascular leakage, can act as a biomarker for the progression to severe sepsis with circulatory failure. The objective of this study is to validate the utility of HBP to predict the development of delayed onset organ dysfunction in sepsis in patients and to compare the performance of HBP relative to currently used prognostic biomarkers in sepsis.

NCT ID: NCT02532959 Completed - Clinical trials for Puerperal: [Major Infection] or [Sepsis]

Diagnostic Breath Analysis Study to Detect Sepsis

Start date: June 2015
Phase: N/A
Study type: Observational

Analysis of exhaled breath samples using a high-speed gas chromatography medical device will identify Volatile Organic Compounds (VOC) that are specifically associated with SIRS and Sepsis. Primary outcome measures will include the assessment of the zNose Diagnostic Breath Analysis System, which includes high-speed gas chromatography, in the early detection of SIRS and Sepsis as compared with current SIRS and Sepsis evaluation methods.

NCT ID: NCT02503761 Completed - Clinical trials for Late Onset Neonatal Sepsis

Bolus Versus Prolonged Infusion of Meropenem in Newborn With Late Onset Sepsis

BVPIMNBLOS
Start date: August 2013
Phase: Phase 3
Study type: Interventional

Newborns in the neonatal intensive care unit (NICU), especially premature ones with immature organ systems, frequently suffer nosocomial infections caused by microorganisms resistant to narrow-spectrum antibiotics like ampicillin and gentamicin and require introduction of new agents with a wider spectrum of activity. Meropenem has activity against wide variety of Gram-negative and Gram-positive bacteria. It is well tolerated by children and neonates, including preterm babies, and allowing monotherapy instead of combined therapy. Severe neonatal infections with increasing antibiotic resistance are major problems affecting morbidity and mortality in the NICU. Few number of new antibacterial agents entering the clinic and new agents for multi-drug resistant Gram-negative bacteria will unlikely be available in the near future.

NCT ID: NCT02486783 Completed - Neonatal Sepsis Clinical Trials

Infection, Sepsis and Meningitis in Surinamese Neonates

InSepSur
Start date: May 2015
Phase: N/A
Study type: Observational

Suriname is a small developing country in South America with a population of half a million people. Early neonatal death in Suriname is high with 16 per 1000 live births. Unpublished data from the Suriname Perinatal and Infant Mortality Survey estimate contribution of infection to early neonatal mortality at 25% (4 per 1000 live births) of all deaths. In comparison, incidence rates of neonatal sepsis alone are 3.5 per 1000 live births. These numbers indicate an increased burden of neonatal infection in Suriname versus the U.S. In any case about 40 newborns that die each year of infection are a huge loss, also considering the small Surinamese community. Despite this overall idea on the impact of infectious disease in Surinamese neonates exact information regarding incidence, type of infection (e.g., localized, viral, early-onset or late-onset sepsis), risk factors (e.g., insufficient antenatal care, maternal Group B-Streptococcus status), etiology, microbial causes, morbidity, antibiotic treatment (type and duration), and epidemiological determinants (e.g., gestational age, sex, ethnicity) are lacking. From a clinical perspective, there is still a challenge to identify neonates with infection. Neonates are often admitted with ambivalent clinical symptoms and receive preventive antibiotics that are costly, promote pathogen-resistance, and have negative long-term effects (i.e., on the development of the intestinal bacterial flora). Currently, assessment of blood leukocyte or trombocyte counts and levels of CRP are insufficiently sensitive to be used as biomarkers, while confirmation of actual sepsis or meningitis by positive culture results is relatively rare (0.5-3% in the United States). This complicates decisions on duration of antibiotic treatment and hospitalization significantly, while no other biomarkers exist. The circulating isoforms of adhesion molecules (cAMs), which mediate interactions of leukocytes with the vascular endothelium, have been proposed as biomarkers for infection and sepsis. During infection they accumulate in the bloodstream as a result of shedding, which represents their removal from cell surfaces of endothelial cells and leukocytes by enzymes called sheddases. Recently, we have reviewed mechanisms behind shedding of cAMs in neonatal, pediatric and adult sepsis. The shedding process reflects a critical and active process in orchestrating interaction between leukocytes and the endothelium for an effective host response, while minimizing collateral tissue damage. As a result, both plasma levels of cAMs and their sheddases are subject to change during infection and sepsis. Additionally, compelling, albeit limited, data suggest changes of levels of cAMs in CSF in adult and pediatric meningitis. To date, some evidence exists of changes in levels of cAMs during malaria (in children from Malawi) and sepsis, although not sensitive enough to predict outcomes in the clinic. Those levels have never been assessed simultaneously with levels of their sheddases in blood or CSF as a diagnostic tool. We propose that this combined approach may provide more detailed information about the extent of inflammatory activation in neonates.While a balance in levels is maintained under resting conditions or mild (local) infection, it may be perturbed during sepsis or meningitis . Thus, simultaneous measurement of these levels could promote early identification of infection, and may even distinguish between mild infection, systemic infection or meningitis. Currently, manufacturers are rapidly developing Luminex® technology as an advanced, fast, high-throughput and clinically feasible bedside tool for such an approach. We hypothesize that incidence rates of neonates with infection in Suriname are high. We further hypothesize that, upon signs of infection, the simultaneous measurement of cAMs and their SEs in serum and CSF discriminates between infected and non-infected neonates. We aim to: 1) identify and follow neonates at the Academic Hospital Paramaribo with signs of infection to establish incidence rates of infection, and 2) investigate diagnostic potential of our proposed biomarker combination in these neonates for infection, type of infection (e.g., local (mild), sepsis or meningitis) and outcomes.

NCT ID: NCT02474797 Completed - Sepsis Clinical Trials

Ultrasound Diaphragmatic Thickening to Monitor Its Dysfunction in Patients With Sepsis

US-Diamonds
Start date: May 4, 2015
Phase: N/A
Study type: Interventional

Diaphragmatic dysfunction is associated with sepsis severity and pejorative prognosis. Aim of this study is to assess diaphragmatic function with the Diaphragmatic Thickening Fraction (DTF) ultrasound measure in patients with severe sepsis or septic shock, mechanically ventilated or not, hospitalized in ICU in order to determinate diaphragmatic dysfunction frequency, its prognosis value and its associated factors. This is a prospective pilot study in a 14-bed medical and surgical ICU including 50 consecutive patients with severe sepsis or septic shock. The expected duration of study is 18 months. DTF is measured each day as follow: the probe is placed in an intercostal space between mid axillary line and anterior axillary line, 0.5cm to 2 centimeters below the costodiaphragmatic sinus. DTF measure is performed in B-mode using the following formula: TF (%) = [(end-inspiration thickness - end-expiration thickness)/(end-expiration thickness) x 100]. A DTF < 20% indicates a diaphragmatic dysfunction. The investigators will collect potential factors for which DTF Ultrasound Measure could have a prognosis value (intubation, successful or failed weaning from mechanical ventilation), potential risk factors (age, sex, tobacco, alcohol etc.) and potentials associated factors. The investigators expect measure of DTF allows identifying patient with severe sepsis or septic shock with diaphragmatic dysfunction. It would also estimate diaphragmatic dysfunction frequency with ultrasound measure and warranting its use routinely at the bedside. The investigators expect that DTF helps to characterize degree of severity of septic patient and can be a new index able to predict intubation in this population.

NCT ID: NCT02473263 Completed - Clinical trials for Severe Septic Syndrome (Severe Sepsis and Septic Shock) Diagnosed and Treated by Mobile Intensive Care Unit

Samu Save Sepsis: Early Goal Directed Therapy in Pre Hospital Care of Patients With Severe Sepsis and/or Septic Shock

SSS
Start date: May 9, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether an aggressive strategy of severe sepsis patients since pre hospital care, including early antibiotics administration, hemodynamic optimization, and opotherapy when indicated, could reduce mortality

NCT ID: NCT02469571 Completed - Sepsis Clinical Trials

Modulation of Gut Microbiota in Early Sepsis: A Pilot Study

MGM-sepsis
Start date: September 1, 2015
Phase: N/A
Study type: Interventional

Background Sepsis is a common disease leading to high morbidity and mortality. Gut microbiota and/or gut permeability may play a crucial role in the development of organ dysfunction. Hypothesis The ingestion of a multispecies probiotic in early sepsis is able to modulate gut microbiota and/or gut permeability.