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NCT ID: NCT02887274 Recruiting - Sepsis Clinical Trials

Application of Stimulated Immune Response Change to Predict Outcome of Patient With Severe Sepsis

SIRCSS
Start date: July 2013
Phase:
Study type: Observational

Persistence of a marked compensatory anti-inflammatory innate immune response after an insult is termed immunoparalysis. There is no biomarker available to determine the immune status of patient. Thus, the need for early and definite diagnosis of immune status of patient with sepsis, as well as the identification of patients at risk of evolving with severe organ dysfunctions, is crucial. Most important of all, speed is the key to survival. Therefore, it of crucial importance to identify which patient characteristic determines the poor prognosis. Early intervention can improve the prognosis. Investigators foresee an urgent need to identify predictors for mortality in severe sepsis, including clinical factors or immune status. Recently, the PIRO model has been proposed as a way of stratifying septic patients according to their Predisposing condition, the severity of Infection, the Response to therapy and the degree of Organ dysfunction. The immune status may be associated with above model. However, there is paucity data addressing this issue. In this study, investigators will also analyze the progression of patient condition during treatment and the associated immune status change. In the future, Investigators hope the determination of immune status may contribute to this model of classification rather than just being used as prognostic markers. Despite the advances in the knowledge of the basic processes that trigger and sustain the systemic inflammatory response in sepsis, the search for a "magic bullet" to treat this syndrome has been frustrating. The incidence of severe sepsis and septic shock still remains quite high, as does its mortality, which has decreased very little over the past decades.

NCT ID: NCT02871895 Recruiting - Sepsis Clinical Trials

Application of Biomarkers Change to Predict Outcome of Patient With Severe Sepsis

BCSS
Start date: July 2013
Phase:
Study type: Observational

In 2004, the Surviving Sepsis Campaign (SSC) introduced guidelines for the management of severe sepsis and septic shock, as well as strategies for bedside implementation. The treatment recommendations were organized in two bundles. In an international study, enrolling adult patients with severe sepsis admitted to these intensive care units, investigators found that while mortality from severe sepsis is high (44.5%), compliance with resuscitation and management bundles is generally poor in much of Asia. Investigators need to identify the patients at risk for high in-hospital mortality in order to take appropriate steps. From their past studies, investigators found that sepsis involved inflammation and coagulation. The multiple organ involvement was associated with interaction of novel biomarkers such as cytokines. There is limited data regarding comparing and application of biomarkers of different characteristic on sepsis treatment. A simultaneous detection of multiple cytokines may provide significant prognostic information. For other biomarkers, promising observation data have been put forward, but their potential needs to be evaluated in large-scale, well-designed prospective intervention studies before clinical use can be recommended. Besides many clinical studies on biomarkers were confounded by its lack of standard bundle care for severe sepsis patient. Here investigators performed a systematic study aimed at evaluating 1. the individual and combined diagnostic accuracy of biomarkers for predicting mortality; 2. whether trend change in biomarker level more useful for above prediction; 3. which biomarker or biomarker combination checked can predict patients at risk of evolving with severe organ dysfunctions.

NCT ID: NCT02707497 Recruiting - Sepsis Clinical Trials

The Effect of REcombinant Human Thrombopoietin (rhTPO) on Sepsis Patients With aCUte Severe thrombocytopEnia

RESCUE
Start date: April 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine whether recombinant human thrombopoietin(rhTPO) can rapidly increase the platelets counts, shorten the time of the platelet returned to normal, reduce platelet transfusion and bleeding events, prompt recovery of organ function, decrease the length of ICU stay, and eventually reduce the 28-day mortality in sepsis patients with severe thrombocytopenia.

NCT ID: NCT02654561 Recruiting - Sepsis Clinical Trials

Efficacy and Safety of Unfractionated Heparin on Severe Sepsis With Suspected Disseminated Intravascular Coagulation

Start date: April 12, 2018
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to estimate the efficacy of unfractionated heparin(UFH) on ICU mortality in severe sepsis with suspected DIC.The Second objective is to estimate the effect of UFH on 28-day mortality,and the change of the Japanese Association for Acute Medicine(JAAM) score and SOFA score. The third one is to evaluate the safety of UFH in severe sepsis patients with suspected DIC.

NCT ID: NCT02589535 Recruiting - Sepsis Clinical Trials

Circulating Stem Cells, SDF-1, HIF-1 and Sepsis's Indices in Emergency Abdominal Surgical Patients

Start date: December 2015
Phase: N/A
Study type: Observational [Patient Registry]

Septic shock is a systemic inflammatory response syndrome with acute circulatory failure secondary to a documented infection. It is the most feared complication in ICU patients, with a 50% mortality rate. The study of stem cells and their experimental use in sepsis treatment is particularly relevant in the international scientific research, where Italy plays an important role. In the vast and complex field of stem cell research, the primary aim of the current proposal is to evaluate the time course level of circulating endothelial progenitor stem cells CD34 + / CD133 + (EPCs), and some factors EPCs-related, such as hypoxia- inducible factor (HIF- 1) and stromal derived factor-1 (SDF-1) in septic patients undergoing major abdominal surgery. Secondary objective 2: to investigate the relationship between CD133/CD34, HIF-1, SDF-1a and outcome of septic/septic shock patients treated with standard conventional therapy alone (CT) or with extracorporeal hemoperfusion therapy (HCT).

NCT ID: NCT02567305 Recruiting - Sepsis Clinical Trials

Neutrophil Extracellular Traps and Neonatal (PV4991) & Pediatric Sepsis (PV5063)

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

This study is designed to assess the role of neutrophil extracellular traps (NETs) in neonatal and pediatric sepsis as well as to evaluate markers of NETs formation as early predictors of neonatal and pediatric sepsis.

NCT ID: NCT02565251 Recruiting - Sepsis Clinical Trials

Volemic Resuscitation in Sepsis and Septic Shock

Start date: September 2015
Phase: N/A
Study type: Interventional

Severe sepsis and septic shock are among the leading causes of morbidity and mortality in patients admitted in the ICU, being responsible for approximately 200000 deaths/year in the USA and 150000 in Europe. Recognizing the early signs of sepsis and the different stages of this condition may lower the associated morbidity and mortality. The hemodynamic profile of the septic shock is characterized by the presence of the distributive shock, on which we can add elements from the hypovolemic and cardiogenic shocks. The objecive of this study is to optimize the volemic resuscitation of the severe septic and of the septic shock patient using two minimally invasive methods of hemdynamic monitoring which both use the same device (Edwards Lifescience). In the same time hemodinamic data will be colected by mesuring the inferior vena cava diameter.

NCT ID: NCT02391792 Recruiting - Clinical trials for Severe Sepsis and Septic Shock

Membrane Shedding During Severe Sepsis and Septic Shock: Pathophysiological and Clinical Relevance

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

Microparticules (MPs) result from plasma cell membrane remodeling and shedding after cell stimulation or apoptosis. MPs are know recognized as a pool of bioactive messengers with merging role in pathophysiology of immune and cardiovascular diseases. MPs have been characterized during septic shock and may contribute to dissemination of pro-inflammatory and procoagulant mediators. This a prospective observational study of circulating MPs and blood coagulation in septic shock patients admitted in medical intensive care units (ICUs) of four tertiary hospitals at baseline (D1, D2, D3, D4, D7).

NCT ID: NCT02370030 Recruiting - Sepsis Clinical Trials

Effect of Citrulline on the Clinical and Biochemical Evolution of Patients With Sepsis.

CITRUSEP
Start date: November 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Triple blind placebo-controlled study to determine if administering citrulline in patients with sepsis and severe sepsis slows progression to multiple organ failure and death, measuring biomarkers of endothelial dysfunction. Patients are divided into placebo or citrulline and followed up for 1 month.

NCT ID: NCT02339649 Recruiting - Clinical trials for Severe Sepsis With Septic Shock

Long-term Cognitive and Cerebral Changes in Sepsis Survivors and Their Predictors

BonSEP
Start date: September 2013
Phase: N/A
Study type: Interventional

The main goals of this study are to provide a cognitive, neurological, brain morphological, and serological profile of sepsis survivors in order to make long-term prognosis of recovery and estimate the need for rehabilitation measures in order to help patients reintegrate into normal daily life.