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Shock, Septic clinical trials

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NCT ID: NCT01948778 Completed - Clinical trials for Patients in Septic Shock

The Effects of a Polyethyleneimine-coated Membrane (oXiris™) for Hemofiltration Versus Polymyxin B- Immobilized Fibre Column (Toraymyxin™) for Hemoperfusion on Endotoxin Activity and Inflammatory Conditions in Septic Shock- A Randomized Controlled Pilot Study (ENDoX-study)

Start date: August 2013
Phase: N/A
Study type: Interventional

Septic shock has a high mortality risk despite the availability of various treatments. Endotoxin, that is present in the cell walls of gram-negative bacteria, is a potent trigger of innate immunity. Endotoxin leads to an activation of a cascade with an overwhelming systemic overflow of pro- and anti- inflammatory mediators at the early phase of sepsis with generalized vascular endothelial damage, tissue injury and multi-organ failure. Extracorporeal blood purification therapies aim to reduce the circulating level of endotoxin. Different extracorporeal blood purification systems are available. The oXiris™ device comprises a surface treated AN69 membrane capable to adsorb a large spectrum of plasma cytokines, such as IL-6 and HMGB1 protein. The positively charged inner surface of the membrane allows absorbing negatively charged bacterial products such as endotoxin. From an historical perspective, filters containing AN69-based membranes have been the most commonly used products for CRRT in the management of critically ill patients and a substantial volume of published data exist. Another extracorporeal endotoxin removal therapy is the hemoperfusion with ToraymyxinTM (PMX) filter, which is a cartridge selectively removing blood endotoxin. PMX is composed of polymyxin B covalently bonded to polystyrene-derivative fibres. It is well known that the polarity of the polymyxin B antibiotic binds endotoxin and has bactericidal activity. Therefore, the rationale underlying extracorporeal therapy with PMX is to remove circulating endotoxin by adsorption. - Trial with medical device

NCT ID: NCT01947127 Completed - Sepsis Clinical Trials

Venous Lactate in Progression to Overt Septic Shock and Mortality in Non-elderly Sepsis Patients in Emergency Department

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

To investigate the role of initial venous lactate in predicting the severity progression to overt septic shock and 30-day mortality in non-elderly patients without hemodynamic shock who suspected to have acute infections.

NCT ID: NCT01945983 Completed - Septic Shock Clinical Trials

Early Use of Norepinephrine in Septic Shock Resuscitation

CENSER
Start date: October 3, 2013
Phase: N/A
Study type: Interventional

Current septic shock guideline recommends fluid resuscitation as the first treatment. Vasopressors, including norepinephrine is recommended to start after achieve adequate fluid therapy. This can cause a certain duration of systemic hypotension before vasopressor is commenced. Initiation of norepinephrine together with fluid therapy soon after diagnosis of septic shock may increase blood pressure quicker than start treatment with intravenous fluid alone. The rapid restoration of perfusion pressure may improve septic shock outcome.

NCT ID: NCT01943747 Completed - Septic Shock Clinical Trials

International Multicentre Prevalence Study on Sepsis

IMPRESS
Start date: November 2013
Phase: N/A
Study type: Observational

To mark 10 years of the Surviving Sepsis Campaign (SSC), and timed to coincide with World Sepsis Day, on September 13, 2013, the SSC, ESICM and SCCM will be conducting an international point prevalence study of severe sepsis and septic shock. The goal of this project is to determine the world wide burden of severe sepsis and define current practices of sepsis care internationally. The study is a simple data collection exercise for patients presenting with either severe sepsis or septic shock on World Sepsis Day.

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: NCT01920776 Recruiting - Septic Shock Clinical Trials

Focused Ultrasound in Septic Shock Patients

Start date: July 2013
Phase: N/A
Study type: Interventional

The investigators hypothesize that lung ultrasound and echocardiography will benefit the septic shock patients by making the treatment more precisely and rapidly. Septic shock patients from multicenter will be enrolled in the study. They will be randomly divided into two groups. The routine treatment group will receive routine treatment according to the SSC guideline. The study group will receive additional ultrasound examination, which will decide the improvement of therapy. Therapy change based on ultrasound results and the prognosis will be recorded.

NCT ID: NCT01877798 Not yet recruiting - Septic Shock Clinical Trials

Venoarterial PCO2 Difference /Arteriovenous O2 Content Difference Ratio as Goal of Early Septic Shock Therapy

Start date: June 2013
Phase: N/A
Study type: Interventional

Reducing tissue hypoxia is the ultimate goal of severe sepsis and septic shock therapy.Venoarterial PCO2 difference /arteriovenous O2 content difference ratio (△PCO2/Ca-vO2) is considered to be a good indicator of global anaerobic metabolism.The purpose of this study was to compare the efficacy of △PCO2/Ca-vO2 and central venous oxygen saturation (ScvO2) in the treatment of severe sepsis and septic shock.

NCT ID: NCT01867905 Completed - Septic Shock Clinical Trials

Antibiotic Administration and Blood Culture Positivity in Severe Sepsis and Septic Shock

Start date: March 1, 2014
Phase:
Study type: Observational

Sepsis is a significant cause health care expenditure and carries an extremely high rate of morbidity and mortality if not treated appropriately. From 1979 to 2000, sepsis resulted in over 10 million admissions to hospital in the United States with a mortality rate of 17.9 to 27.8 percent. In Canada, it is estimated that the incidence of sepsis from 2008-2009 was 103.3 per 100,000 per year. Advances in the multifaceted management of sepsis in recent years have resulted in improved clinical outcomes. However, the cornerstone of sepsis management relies on the prompt administration of appropriate antibiotics. Current clinical practice suggests that antibiotic administration can be delayed up to 45 minutes in order to obtain blood cultures, whose results have a profound impact on the type and duration of antimicrobial therapy. Unfortunately, this recommendation is based on very little evidence and the investigators have found that potential life-saving treatment is often delayed in order to abide by it. Furthermore, recent data suggest that mortality could be increased by approximately 5% by delaying antibiotic administration for that time period. The investigators therefore wish to organize a prospective, multi-centre trial in order to identify the effect of antibiotic administration on blood culture positivity in patients presenting with severe sepsis or septic shock. Other objectives will be to elucidate which patient factors, including age, co-morbid conditions and clinical presentation, as well as antibiotic choice will affect blood culture results. This study will be conducted in the emergency departments at St. Paul's Hospital (SPH), Vancouver General Hospital (VGH), Lion's Gate Hospital (LGH), Surrey Memorial Hospital, Montreal General Hospital (MGH), Royal Victoria Hospital (RVH) and Maricopa Integrated Health System. Patients identified for the aforementioned conditions will be treated as per routine hospital protocol. If the patient is deemed eligible for the study, a second set of blood of blood cultures will subsequently be drawn ideally between 30 and 60 minutes after the administration of antibiotic therapy. Subject demographic data will be collected pertaining to age, comorbid immunocompromised conditions, vital signs, laboratory tests pertaining to end organ dysfunction, suspected source of sepsis, the type antibiotics administered and the timing of antimicrobial administration with respect to the second set of blood cultures taken. Our hypothesis is that blood culture positivity in patients presenting with severe sepsis and septic shock will not be altered significantly by antibiotic therapy. If so, our study would strongly argue against delaying life-saving therapy and would thus greatly improve patient care in our local emergency rooms. If incorrect, our study would be the first to demonstrate the benefit of obtaining blood cultures before antibiotic therapy and would strengthen current recommendations.

NCT ID: NCT01862588 Recruiting - Acute Kidney Injury Clinical Trials

Renal Resistive Index and Cardiac Output Changes During Resuscitation Predict the Occurrence of Acute Kidney Injury in Septic Shock Patients

CORRI
Start date: January 2013
Phase: N/A
Study type: Observational

Record the renal resistive index and hemodynamic parameters ( record the cardiac output and stroke volume if the patient's next to kin agree to undertake a PiCCO monitoring ) before and after resuscitation for severe sepsis or septic shock patients, to determine whether the changes of resistive index or hemodynamic parameters, especially the cardiac output can be a better parameter to predict AKI

NCT ID: NCT01858909 Not yet recruiting - Septic Shock Clinical Trials

Efficacy of Melatonin in Patients With Severe Sepsis or Septic Shock

Start date: May 2013
Phase: Phase 3
Study type: Interventional

OBJECTIVES. To establish the therapeutic efficiency of melatonin in adult patients with severe sepsis and septic shock. Specifically: 1. To evaluate the survival to 28 days of mechanical assisted ventilation, days with vasoactive drugs, need of hemodialysis-hemofiltration, superinfection and evolution towards the failure of other organs. 2. To evaluate, waiting for reduction under the influence of the treatment with melatonin, : 1. clinical - analytical parameters of sepsis; 2. levels of cytokines; 3. oxidative and nitrosative stress; 4. acute-phase proteins (APP), specially of the ITIH4; 5. immune response; 6. endocrine response. METHODOLOGY. Patients will be randomized in two groups, n = 55 in each group: 1) treatment with melatonin 30mg/12 hours 28 days; 2) placebo. Determinations: a) clinical - analytical parameters relative to the sepsis; b) melatonin plasmatic levels; c) quantification of malonyldialdehyde and 4-hydroxynonenal, protein carbonyl content, nitrites, erythrocyte membrane fluidity, and superoxide dismutase, catalase, glutathione reductase and glutathione peroxidase activity; d) Interleukins-1,2,4,5, 6, 7,8,10,12,13, IFN-γ; TNF-α and GM-CSF; e) acute-phase proteins: PCR, haptoglobin, Apo A-I, α1-GPA and ITIH4; f) lymphocytes T, B, NK, T CD4, and T CD8, and immunoglobulins; g) cortisol, aldosterone, ACTH, ADH, insulin, glucagon and 25-hydroxyvitamin D3. Data will be analyzed following a prospectively define plan and by intention-to-treat (ITT) analysis.