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Toxemia clinical trials

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NCT ID: NCT02213796 Completed - Clinical trials for Initial Phase of Severe Sepsis and Septic Shock

Population Pharmacokinetics and Monte Carlo Dosing Simulations of Meropenem During the Early Phase of Severe Sepsis and Septic Shock in Critically Ill Patients in Intensive Care Units

Start date: January 2013
Phase: Phase 4
Study type: Interventional

This is a prospective, noncomparative study to assess the pharmacodynamics of meropenem during early phase of severe sepsis and septic shock in critically ill patients in an intensive care unit. Clinical and laboratory data such as age,sex, body weight, electrolyte, vital signs, APACHE II score, SOFA score, BUN, Cr and blood culture will be collected. Twelve patients will be enrolled in this study. Meropenem pharmacokinetic will be carried out during the first and second dose after 1g meropenem administration. Blood samples (approximately 3 ml) will be obtained by direct venepuncture at the following time: 0, 0.25, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 8, 8.5, 9, 9.5, 10, 12, 14 and 16 h. Meropenem assays will be performed by modified method of Ozkan et al. (Biomed. Chromatogr., 2001). The pharmacokinetics of meropenem will be modelled from concentration-time profile using compartmental model. Monte Carlo simulation to assess PK/PD index as 40% and 100% T>MIC will be conducted and the results will be reported as % PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response)

NCT ID: NCT02213237 Recruiting - Sepsis Clinical Trials

The Application of SERS and Metabolomics in Sepsis

Start date: July 2011
Phase: N/A
Study type: Observational

It has always been a real challenge to treat sepsis in critically ill patients. The mortality is as high as 20% in patients with severe sepsis and 46% with septic shock develops. Early diagnosis and early treatment are the principles. Along with appropriate resuscitation, judicious and thoughtful intravenous antibiotic therapy is the critical determinant of survival in sepsis and septic shock given that ineffective initial therapy worsens the outcome. Blood culture and subsequent susceptibility testing are the gold standard for microbiological diagnosis to direct the optimal use of antibiotic. However, this conventional approach usually takes 5-7 days to wait for the final report. Positive results were reported in only 30% of patients with sepsis and 50 to 60% septic shock. Moreover, the very low bacteria level in blood and prior use of antibiotics may prevent pathogen growth. Surface-enhanced Raman scattering (SERS) is a novel spectroscopy technique based on Raman scattering and localized surface plasma resonance (LSPR), which results in strongly enhanced Raman signals derived from molecules attached to nanometre-sized gold (Au) and silver (Ag) structures. SERS provides the structural information of biomedical molecules with ultra-sensitive characterization down to single molecular level in fast and non-destructive manner. The clinical application of SERS in sepsis will first help to recognize pathogens as well as their specific drug sensitivity, and then optimally guide the initial antibiotics usage. Plasma from twenty blood culture proven Gram positive, negative and Candida cases will separately subject to metabolomics profiling and bioinformatics analysis to establish each pathogen metabolites profile. The sensitivity and specificity of SERS and metabolomics in identifying pathogen and antibiotics-resistant strains will be evaluated. The investigators expected both techniques to play a crucial role in modern sepsis treatment and bring great impact on mortality reduction.

NCT ID: NCT02195830 Not yet recruiting - Sepsis Clinical Trials

Inferior Vena Cava Collapsibility Index in Severe Sepsis

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

There is debate regarding the use of non invasive (ultrasound assessed) parameters of fluid volume status in patients with sepsis. To establish the role of inferior vena cava ultrasound in guiding fluid resuscitation we first need to define the inferior vena cava collapsibility index in this population of patients. The research question is: In adult patients with sepsis, severe sepsis and septic shock what is the mean baseline inferior vena cava collapsibility index (IVCCI) prior to fluid resuscitation.

NCT ID: NCT02188992 Completed - Sepsis Clinical Trials

Early PREdiction of Severe Sepsis I (ExPRES-Sepsis I) Study

ExPRES
Start date: January 2014
Phase: N/A
Study type: Observational

Between 6 and 16% of patients presenting to hospital emergency departments have infections, with half of these having signs of systemic inflammation (known as 'sepsis'). A second issue is that, at time of presentation, it can be difficult to determine who has inflammation as a result of infection and who does not. Some of the patients with infections will deteriorate to organ failure ('severe sepsis') including failure of the heart and blood vessels to maintain normal blood pressure ('septic shock'). Septic shock as arguably the most dangerous form of severe sepsis is associated with a significant mortality, which can be reduced by early intervention. However identifying those patients who are at high risk of deteriorating to septic shock can be difficult on initial presentation to hospital, and thus these patients risk being 'triaged' to an inappropriate level of care and/or missing the crucial early interventions which can modify mortality. Equally failure to identify which patients have underlying infections can lead to potential inappropriate targeting of antibiotics. Existing clinical and laboratory tests are often unable to accurately identify those patients with infection, and those who are likely to deteriorate to severe sepsis and septic shock. Investigators in this group have recently identified several signatures of immune system activation which predict those patients who are likely to deteriorate, and which patients with suspected infection subsequently have this confirmed. Such tests would have major benefits for the management of patients with early suspected infection and sepsis if they can be translated into a test usable in everyday clinical practice. This study aims to determine the prevalence of these markers in a cohort of patients admitted with suspected sepsis, and their predictive ability for developing established septic shock. From this investigators aim to derive an optimal test, to be tested in a validation cohort (ExPRES-Sepsis II) which will be suitable for everyday clinical practice, and thus take the next step towards developing a market-ready test. Study hypothesis is: Measurement of markers of immune activation will allow i) Risk stratification for deterioration into severe sepsis ii) Risk stratification for death amongst patients presenting with sepsis iii) Identification of patients with confirmed sepsis

NCT ID: NCT02180399 Recruiting - Sepsis Clinical Trials

Serial Measurement of Capillary Blood Lactate in the Management of Sepsis

SepsisMI
Start date: February 2014
Phase: N/A
Study type: Observational

Determination of capillary lactate by using "point-of-care" technique is accessible, fast and allows to quantify the circulatory and metabolic dysfunction caused by sepsis. Compared to conventional assay techniques in arterial blood, capillary assay technique may have an increased susceptibility to metabolic alterations induced by sepsis in its initial stages. This increased sensitivity is not necessarily relevant in the management of the most serious patients for whom the diagnosis is obvious, but it could be very useful in patients for whom a diagnosis of severe sepsis or shock have not yet been adopted, particularly to help better identify patients who would require intensive management and avoid the installation of these serious disorders.

NCT ID: NCT02180009 Completed - Sepsis Clinical Trials

Dynamic Changes of Tim-3 on Monocytes and Soluble Tim-3 in Patients With Sepsis

Start date: December 2013
Phase: N/A
Study type: Observational [Patient Registry]

In this study, the investigators will dynamically detect the expression of an immune regulator- T cell Ig and mucin domain protein 3 (Tim-3) in patient with sepsis.

NCT ID: NCT02170233 Completed - Sepsis Clinical Trials

SHOCK US STUDY: Fluid Responsiveness in Sepsis Measured by Ultrasonography

Start date: August 2014
Phase:
Study type: Observational

The study aim is to examine point-of-care ultrasound findings, reliability, and ease of performance in association with fluid responsiveness for patients with severe sepsis and septic shock. The investigators propose a prospective observational research study of patients presenting to one of three Yale New Haven Hospital emergency departments, York Street Campus, St. Raphael's Campus, and Shoreline Medical Center who meet criteria for sepsis, severe sepsis or septic shock during their emergency department visit.

NCT ID: NCT02165501 Active, not recruiting - Clinical trials for Severe Sepsis or Septic Shock (ICD-10-GM, R65.0, R65.1)

Jena Sepsis Registry

JenaSepsisReg
Start date: January 2011
Phase: N/A
Study type: Observational [Patient Registry]

Despite the burden of severe sepsis and septic shock deficiencies in the quality of sepsis management are recognized. Investigators present a population-based registry with easy feasibility as part of German Center for Sepsis Control & Care (CSCC). All ICU patients of the Jena University Hospital, Germany will be screened for inclusion (severe sepsis or septic shock). Baseline data on ICU- and hospital care will be extracted from patient records at ICU discharge. The primary outcome is change in all-cause mortality from baseline to follow up at 6, 12, 24, 36, 48 and 60 months after diagnosis of sepsis. Follow-up data will be collected from the primary care provider of the patient. The registry may provide valid data on quality in sepsis care.

NCT ID: NCT02159222 Terminated - Sepsis Clinical Trials

Sepsis Trial of Early Physical Therapy Outside the ICU

STEP TO IT
Start date: April 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether an additional physical therapy program can improve the mobility and functional outcomes of patients diagnosed with severe sepsis (an illness in which the body has a severe response to bacteria or other germs and develops worsened function of a major organ such as the kidneys, heart, or lungs).

NCT ID: NCT02159079 Completed - Sepsis Clinical Trials

A Randomized Controlled Trial of a Conservative Fluid Balance Strategy for Patients With Sepsis and Cardiopulmonary Dysfunction (BALANCE Study)

BALANCE
Start date: July 2014
Phase: N/A
Study type: Interventional

Sepsis is a common inflammatory response to infection characterized by hypovolemia and vasodilation for which early administration of intravenous fluids has been suggested to improve outcomes. The ideal fluid balance following initial resuscitation is unclear. Septic patients treated in the intensive care unit commonly receive significant volumes of intravenous fluids with resultant positive fluid balance for up to a week after their initial resuscitation. Observational studies have associated fluid receipt and positive fluid balance in patients with severe sepsis and septic shock with increased mortality but are inherently limited by indication bias. In order to determine the optimal approach to fluid management following resuscitation in patients with severe sepsis and septic shock, a randomized controlled trial is needed. The primary hypothesis of this study is that, compared to usual care, a conservative approach to fluid management after resuscitation in patients with sepsis and cardiopulmonary dysfunction will increase intensive care unit free days.