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Shock, Septic clinical trials

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NCT ID: NCT02044575 Completed - Septic Shock Clinical Trials

Clock Genes in Patients With Refractory Septic Shock (SeptiClock) - Pilot Study

Start date: April 2014
Phase:
Study type: Observational

Despite large efforts trying to improve diagnostic and therapy of sepsis have been made over the last decade (e.g. initiation of the Surviving Sepsis Campaign, defining evidence based sepsis therapy bundles) the mortality of septic shock remains high and causes high socioeconomical burden of disease. The purpose of this pilot study is to evaluate the design and conduct of a projected full scale clinical trial.

NCT ID: NCT02041663 Completed - Septic Shock Clinical Trials

Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis

SAMIRA
Start date: March 5, 2012
Phase: N/A
Study type: Interventional

Use of brain natriuretic peptide to evaluate the cardiac function in the course of meningococcal septic shock or severe sepsis.

NCT ID: NCT02030158 Completed - Clinical trials for Severe Sepsis and Septic Shock

Statistical Analysis Plan for an Individual Patient Data Meta-analysis of Three, International Trials Comparing Protocolised With Usual Resuscitation in Patients Presenting to the Emergency Department With Severe Sepsis and Septic Shock

Start date: January 2015
Phase:
Study type: Observational

This is the statistical analysis plan for an individual patient data meta-analysis (IPDMA) of three EGDT clinical trials.

NCT ID: NCT02025660 Completed - Septic Shock Clinical Trials

Efficacy of Mw Vaccine in Treatment of Severe Sepsis

MISS
Start date: August 2013
Phase: Phase 2/Phase 3
Study type: Interventional

Study Hypothesis Enhancement of Th-1 response with the help of a poly TLR agonist (Mw) is likely to increase survival in patients with severe sepsis. Objectives To study whether immunomodulation with Mycobacterium Mw helps in improving survival and the recovery of organ function in patients with severe sepsis. This will be assessed with the help of the following - Mortality in the two arms - Daily SOFA scores - Ventilator free days - Time-to-vasopressor withdrawal - ICU length of stay - Hospital length of stay METHODS This will be a proof of the concept study to assess the effect of Mycobacterium w in combination with standard therapy versus standard therapy alone on the inflammatory profile in sepsis due to gram negative infection. A total of 25 patients will be enrolled in each group. The patients will be randomized in balance to receive either test drug or its placebo along with the standard of care

NCT ID: NCT02025127 Completed - Septic Shock Clinical Trials

A Randomized Controlled Study of Enteral Nutrition in Septic Shock

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

There is a paucity of data on the timing and role of enteral nutrition in septic shock. The primary aim of this study is to conduct a phase III single-center pilot randomized controlled trial comparing early trophic enteral nutrition to 'no enteral nutrition' in mechanically ventilated septic shock patients to determine feasibility.

NCT ID: NCT02002676 Unknown status - Sepsis Clinical Trials

Prevalence and Outcome of Hypermetabolism in Initial Prevalence and Outcome of Hypermetabolism in Initial Phase of Intensive Care Unit Patient: a Prospective Observational Study

Start date: December 2013
Phase: N/A
Study type: Observational

Patients in critical illness frequently present hypermetabolism, which can extremely increase the rest energy expenditure(REE). We hypothesize that if we alleviate the extremely increased REE will improve ICU patients' outcome

NCT ID: NCT01988428 Completed - Sepsis Clinical Trials

Prehospital Antibiotics Against Sepsis Trial

PHANTASi
Start date: June 2014
Phase: N/A
Study type: Interventional

Sepsis is one of the most frequent reasons for referral to emergency departments (EDs) worldwide. The incidence of sepsis is likely to rise in the upcoming years. Sepsis has a tendency to become more serious when left untreated with a high mortality rate, exceeding even those of myocardial infarction and stroke. Therefore, much effort has been put in to start with appropriate therapy as early as possible. Early goal-directed therapy (EGDT) in the emergency department with fluid resuscitation, administration of vasopressors/vasodilators and intravenous antibiotics in patients with severe sepsis and septic shock has indeed decreased mortality substantially. Emergency medical services (EMS) personnel have already made a significant difference in improving care for patients with acute coronary syndrome, multiple trauma and stroke. Patients with severe sepsis or septic shock could also benefit greatly from timely pre-hospital care. Earlier recognition and initiation of treatment by EMS personnel may improve survival even more. Interestingly, the first hour of ED presentation seems to be the most critical hour. Administration of antibiotics and fluid resuscitation in the pre-hospital setting will reduce the time to administration substantially. In adults, to the best of our knowledge, no studies on the effect of pre-hospital administration of antibiotics have been performed. In children with meningitis, some uncontrolled studies show contradictory results, most probably due to bias by severity. We propose a non-blinded randomised multicentre clinical trial study on the efficacy of early, pre-hospital intravenous administration of broad spectrum antibiotics (ceftriaxone), which are effective against a wide variety of infectious pathogens that cause most common community-acquired infections) in patients referred to the ED with suspected severe sepsis or septic shock. Objective: To evaluate whether early, pre-hospital administration of antibiotics, together with training of ambulance personnel in recognizing and initiating treatment reduces 28-day mortality in patients referred to the ED with suspected severe sepsis or septic shock Study design: Non-blinded randomized multicentre clinical trial nested within a stepped wedge design Study population: All patients above the age of 18 years, with suspected severe sepsis or septic shock and transferred to the ED by ambulance, are eligible for study inclusion Intervention: prehospital antibiotics (ceftriaxone 2000 mg intravenously) Main study parameters/endpoints: 28-day mortality, hospital length of stay, admission to intensive or medium care unit (ICU/MC), time to administration of antibiotics. Follow up of one year. QoL after one month after discharge.

NCT ID: NCT01973907 Completed - Septic Shock Clinical Trials

Pilot Study for the SQUEEZE Trial

SQUEEZE
Start date: January 2014
Phase: Phase 3
Study type: Interventional

The purpose of the SQUEEZE Trial is to determine which fluid resuscitation strategy results in the best outcomes for children treated for suspected or confirmed septic shock. In this study, eligible children will be randomized to either the 'Usual Care Arm' or the 'Fluid Sparing Arm'. Children will receive treatment according to current ACCM Septic Shock Resuscitation Guidelines, with the assigned resuscitation strategy used to guide administration of further fluid boluses as well as the timing of initiation and escalation of vasoactive medications to achieve ACCM recommended hemodynamic targets.

NCT ID: NCT01972828 Completed - Septic Shock Clinical Trials

Early Haemodynamic Optimization Using Preload Dependence During Septic Shock = EHOSS-1

EHOSS-1
Start date: July 2007
Phase: N/A
Study type: Interventional

Haemodynamic optimization is of paramount importance in septic shock, but is really consensual and standardized during the first 6 hours of treatment. Haemodynamic treatment including fluid loading management, vasoactive treatment and oxygen transport optimization is mainly based on expert recommendations or non-randomized trials. Recently, preload dependence indexes such as pulse pressure variation have been shown to be more accurate to predict fluid responsiveness than static indexes such as filling pressures. However, whether using preload dependence indexes changes septic shock prognostic remains to date unknown. The aim of this non-blinded randomized controlled trial is to assess whether haemodynamic optimization using preload dependence indexes and pulmonary thermodilution 1. reduces septic shock duration assessed by administration duration of vasoactive treatment (primary end point), 2. reduces regional hypoperfusion assessed by arterial lactate, 3. reduces lung hydrostatic oedema linked to excessive fluid loading (assessed by PaO2/FIO2 ratio and extravascular lung water). 4. reduces organ dysfunction (assessed by the SOFA score), ICU stay and 7 and 28 day mortality Control group is managed with an algorithm using filling pressures to drive haemodynamic treatment.

NCT ID: NCT01957254 Terminated - Septic Shock Clinical Trials

Investigate the Activity of Endotoxin in Severe Sepsis

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

Endotoxin is the major mediator of gram-negative bacteria which cause the systemic inflammation and result in microcirculatory dysfunction, and it leads to multiple organ dysfunction and death in patients with severe sepsis and septic shock. The goal of this study is to measure the endotoxin activity of patients with severe sepsis and septic shock at certain time points, and furthermore, to compare the difference of endotoxin activity among different pathogens, infection source, and antibiotics. The study will enroll severe sepsis and septic shock patients. The endotoxin activity will be measured at certain time points according to the protocol.