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Sepsis clinical trials

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NCT ID: NCT03334227 Terminated - Severe Sepsis Clinical Trials

High Flow Nasal Cannula in Severe Sepsis

OPTISEPSIS
Start date: January 8, 2018
Phase: N/A
Study type: Interventional

Severe sepsis leads a high morbidity and mortality by causing organ damage at distance. The treatment relies on early antibiotic therapy and hemodynamic resuscitation. Hypothesis: high flow nasal cannula (HFNC) could reduce work of breathing and improve the outcome of patients with severe sepsis and peripheral perfusion. Objective: the aim of this study is to evaluate the efficacy of HFNC for improving sixty-day survival in patients with severe sepsis. Design: multicenter parallel-group randomized clinical trial. Method: 592 adult patients with a diagnosis of severe sepsis in the first 12 hours of admission in the Emergency Room will be randomly assigned to an experimental or control group. In the experimental group, HFNC will be administered until the resolution of sepsis or until required mechanical ventilation, either invasive or non-invasive. In the Control group, conventional oxygen will be administered, if required. Sixty-day survival will be the primary outcome. The study is powered to demonstrate an improvement in survival from 70% in control group up to 80% in the HFNC group. The secondary outcomes will be reducing the need for vital support (mechanical ventilation, dialysis, vasoactive drugs) and physiological (acidosis, clearance of lactate, SvO2 and SOFA). Statistical analysis: Kaplan-Meier curves and Cox proportional hazard models will be calculated for all-cause sixty-day survival. If the results are conclusive, they will have immediate application in medical practice.

NCT ID: NCT03320785 Terminated - Sepsis Clinical Trials

Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation

NEOINFLAM
Start date: September 1, 2017
Phase:
Study type: Observational

Circulating markers to diagnose complications (sepsis, necrotizing enterocolitis) in preterm infants are often inaccurate, partly due to the lack of comprehensive studies with temporal evaluation from birth until a disease onset. The investigators plan to collect weekly blood samples of preterm infants from birth until 4 weeks of age to comprehensively characterize differential protein and epigenetic markers in infants with and without complications (sepsis, necrotizing enterocolitis, chorioamnionitis).

NCT ID: NCT02903082 Terminated - Severe Sepsis Clinical Trials

Following of Myeloid-derived Suppressor Cells (MDSC) in Severe Sepsis: What Relationship With Systemic Inflammatory Syndrome?

MDSC
Start date: April 2015
Phase:
Study type: Observational

Sepsis remains a major cause of death in developed countries. A better understanding of the mechanisms involved in the regulation of inflammatory and immune response of patients with severe sepsis is an important step that could open the way for new therapeutic approaches.

NCT ID: NCT02872792 Terminated - Sepsis Clinical Trials

Early Mobilisation in Intensive Care Unit : Interest of Cyclo-ergometry in Patients With Septic Chock

MUEVELO
Start date: December 14, 2016
Phase: N/A
Study type: Interventional

Cycloergometer is a validated method for different care. This kind of device allow passive and active care for patient. The interest of cycloergometer for patient hospitalized in Intensive Care Unit for Sepsis has never been demonstrated. The main objective of this study is to determine the impact of early mobilization by cyclo-ergometer in association with standard physiotherapy, on the ICU length in patients with septic shock The secondary objectives of this study are to assess the impact of early mobilization by cyclo-ergometer in association with standard physiotherapy on: 1. the duration between hemodynamic stability* and the removal of sedation 2. the duration between the removal of sedation and ICU discharge 3. the mechanical ventilation duration (invasive and noninvasive)

NCT ID: NCT02871024 Terminated - Sepsis Clinical Trials

Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection

Start date: August 2016
Phase: N/A
Study type: Interventional

Toraymyxin is an extracorporeal hemoperfusion cartridge containing Polymyxin B-immobilized fiber column designed to reduce blood endotoxin levels in sepsis. Meta-analysis of randomized trials showed that polymyxin B hemoperfusion significantly reduced the mortality of severe sepsis; however, the evidence was mainly contributed by the studies of abdominal sepsis. The data about using polymyxin B hemoperfusion to treat non-abdominal sepsis remain very limited. Investigators designed a clinical trial to evaluate the efficacy of polymyxin B hemoperfusion on treating non-abdominal severe sepsis. The study hypothesis is that removal of endotoxin by polymyxin B hemoperfusion in patients with pneumonia or urinary tract infection (UTI)-related severe sepsis will attenuate sepsis associated microcirculation failure and result in early reversal of shock and less extent of end-organ damage.

NCT ID: NCT02797431 Terminated - Clinical trials for Severe Sepsis With Septic Shock

Immune Reconstitution of Immunosuppressed Sepsis Patients

IRIS-7a
Start date: January 14, 2016
Phase: Phase 2
Study type: Interventional

A multicenter, randomized, double-blinded, placebo-controlled study of two dosing frequencies of recombinant Interleukin-7 (CYT107) treatment to restore absolute lymphocyte counts in sepsis patients; IRIS-7A (Immune Reconstitution of Immunosuppressed Sepsis patients). A parallel study will be performed in United State of America to allow a common statistical analysis of the primary end points and analysis for the enrolled patient population.

NCT ID: NCT02790996 Terminated - Clinical trials for Late Onset Neonatal Sepsis

Neonatal Vancomycin Trial

NeoVanc
Start date: February 27, 2017
Phase: Phase 2
Study type: Interventional

The study aims to compare the efficacy, safety and pharmacokinetics (PK) of an optimised dosing to a standard dosing regimen of vancomycin in neonates and infants aged ≤ 90 days with late onset bacterial sepsis known or suspected to be caused by Gram-positive microorganisms

NCT ID: NCT02734147 Terminated - Sepsis Clinical Trials

High Dose Intravenous Ascorbic Acid in Severe Sepsis

Start date: April 1, 2016
Phase: Phase 2
Study type: Interventional

Despite an organized treatment approach outlined in expert-consensus guidelines for sepsis with fluid resuscitation to treat hypovolemia, antibiotics to target the infectious insult, and vasopressors for hypotension, mortality rates for sepsis remain high and the incidence continues to rise, making sepsis the most expensive inpatient disease. 1. Recent research has described the therapeutic benefits associated with ascorbic acid treatment for sepsis. 2. Researchers objectives are to perform a randomized-controlled clinical trial investigating the ability of ascorbic acid(vitamin C) administration to decrease organ dysfunction in severe sepsis. The widespread occurrence of microvascular dysfunction in sepsis leading to tissue hypoxia, mitochondrial dysfunction, and adenosine triphosphate (ATP) depletion, gives rise to organ failure. 3. Patients with organ failure and sepsis (severe sepsis) are at a higher risk of death than patients with organ failure alone. Critically ill patients may have an increased requirement for ascorbic acid in sepsis and these patients frequently have levels below normal. Ascorbic acid administration, has been shown to correlate inversely with organ failure (human literature) and directly with survival (animal studies). 4,5 Intravenous ascorbic acid therapy decreases organ failure by providing a protective effect on several microvascular functions including improving capillary blood flow, decreasing microvascular permeability, and improving arteriolar responsiveness to vasoconstrictors. Defining the utility of novel agents to augment researchers care for severe sepsis is an important task as investigators continue the institutional focus on sepsis care.

NCT ID: NCT02731144 Terminated - Sepsis Clinical Trials

Optimized Caloric-proteic Nutrition in Septic and Septic Shock Patients

Start date: June 2016
Phase: Phase 4
Study type: Interventional

In this pilot randomized prospective controlled trial the investigators intend to compare the use of a nutritional therapy based on caloric intake determined by indirect calorimetry and high protein intake with nutritional regimen based on 25 Kcal / kg / day and protein intake usually recommended for critically ill patients (1.4 to 1.5 grams / kg / day of protein).

NCT ID: NCT02704871 Terminated - Sepsis Clinical Trials

The Ward Study for SeptiCyte® Lab to Distinguish Between Infection-positive and Infection-negative SIRS

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

A non-interventional, prospective observational study to assess the performance of SeptiCyte® Lab to diagnose patients identified as suspected of sepsis in general medical and surgical wards with infection-positive from infection-negative SIRS