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Shock, Septic clinical trials

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NCT ID: NCT02600312 Completed - Acute Kidney Injury Clinical Trials

Comparing Cytokines, Toxins Adsorbing oXiris Filter to ST150 Filter During CRRT in Patients With Septic Shock

oXiris
Start date: October 2015
Phase: N/A
Study type: Interventional

The Oxiris® filter is a registered product for CRRT already safely used in routine care. In in vitro experiments, the Oxiris® filter has been demonstrated to adsorb endotoxin and cytokines. Compared to conventional filters this may be advantageous in patients with severe sepsis but neither decreased levels of endotoxin and cytokines nor an improved outcome has been demonstrated with clinical use. But there are so far little clinical data on the oXiris® filter on humans. The oXiris® filter will be investigated in a double blind randomized crossover setting against a traditional filter (ST150). Either filter will be used for 24 hours after which it will be changed to the opposite filter for another 24 hours. Arterial blood samples will be drawn at start and then 1, 3, 8, 16 and 24 hours after the start of each filter, and analyzed for endotoxin (EAA assay), TNF-α, IL-1β, IL-6 and IL-10 (ELISA) levels. Standard blood tests will be analyzed simultaneously. Data concerning mode and settings of CRRT, heart rate, blood pressure, medication, data concerning ventilatory support and pathogen will be registered. Primary endpoint: Levels of endotoxin and cytokines will be compared using Student's paired t-test on AUC values for each 24-hour period.

NCT ID: NCT02580240 Recruiting - Septic Shock Clinical Trials

Administration of Hydrocortisone for the Treatment of Septic Shock

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

The purpose of this study : 1)to determine whether hydrocortisone is effective in the treatment of septic shock and 2) to identify the role of timing of low dose hydrocortisone administration in septic shock patients.

NCT ID: NCT02579525 Completed - Critical Illness Clinical Trials

Targeted Tissue Perfusion Versus Macrocirculatory-guided Standard Care in Patients With Septic Shock

TARTARE-2S
Start date: May 2016
Phase: N/A
Study type: Interventional

Background: The recommended monitoring and target levels in septic shock (SSC Guidelines 2012) including mean arterial pressure (MAP) target are not based on robust clinical data. Objective: To test, if in patients with septic shock, tissue perfusion guided (TPG) treatment strategy leads to a faster resolution of hypoperfusion than the macrocirculatory target guided standard care. Design: A prospective phase II two-parallel-group open-label randomized controlled trial Interventions: 1. Intervention group- Targeted tissue perfusion guided (TTP) - care. 2. Control group - Macrocirculatory - guided (MCG) care. Randomization: 1:1 stratified according to the site and presence or absence of known hypertension. Trial size: 200 randomised patients in 4 ICUs.

NCT ID: NCT02576457 Terminated - Septic Shock Clinical Trials

Safety, Pharmacokinetics and Pharmacodynamics of BMS-936559 in Severe Sepsis

Start date: December 2, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether BMS-936559 is safe and has the desired pharmacologic activity in patients who have severe sepsis.

NCT ID: NCT02566460 Completed - Septic Shock Clinical Trials

The Effect of Lactate Clearance Oriented Haemodynamic Therapy on the Outcome of Patients With Septic Shock

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

The purpose of this study is to explore and assess possible outcome benefits of lactate clearance>30% vs ScvO2 ≥70% in 6 hours as the protocol goal that evaluated adequacy of during early resuscitation of septic shock through a single-center randomized controlled study. The investigators anticipate to collect 300-400 qualified patients with septic shock who were selected from critically ill patients admitted to the Department of Critical Care Medicine. The participants can be randomized divided into lactate clearance group and SCVO2 group. The investigators compared the treatment and the relevant parameters changed after different target. 28-day mortality, ICU and hospital lengths of stay, ventilator-free days, and new emerged organ failure were collected and compared. 28-day survival curves were drew between these two group. And the adverse events of the treatment have also been compared. Through this study, the investigators want to answer that whether lactate clearance-oriented therapy can reduce the mortality in patients with septic shock, compared with ScvO2-oriented protocolised therapy.

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: NCT02547467 Not yet recruiting - Septic Shock Clinical Trials

TOADS Study: TO Assess Death From Septic Shock.

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

The aim of this study is to assess the causes of death in patients with septic shock in French intensive care units. It is an epidemiologic and descriptive study .

NCT ID: NCT02533011 Completed - Sepsis Clinical Trials

Evaluation of the Heparin Binding Protein Levels in Sepsis

HBP
Start date: July 2015
Phase: N/A
Study type: Observational

Present criteria used to define sepsis are non-specific, making it difficult to both distinguish sepsis from other diseases and to predict which patients are likely to become more severely ill. In standard care, patients at risk of becoming more severely ill are neither identified nor indicated for resuscitative efforts until they develop hemodynamic insufficiency or organ failure; after progression to severe disease, mortality increases significantly. The identification of risk patients can lead to earlier initiation of resuscitation therapies and potentially lead to reduced morbidity and mortality. This study aims to determine whether Heparin-binding protein (HBP), which is secreted from neutrophils during infection and a mediator of vascular leakage, can act as a biomarker for the progression to severe sepsis with circulatory failure. The objective of this study is to validate the utility of HBP to predict the development of delayed onset organ dysfunction in sepsis in patients and to compare the performance of HBP relative to currently used prognostic biomarkers in sepsis.

NCT ID: NCT02519699 Completed - Septic Shock Clinical Trials

Microcirculation After MAP Increase in Septic Shock Patients With Previous Hypertension

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

The optimal levels of mean arterial pressure that must be achieved in septic shock are subject of debate. Studies tried to correlate blood pressure increase in patients with septic shock with microcirculation. However, there are few studies that specifically assessed septic shock patients with previous arterial hypertension. The main objective of this study is to evaluate the effect of increased blood pressure level in the microcirculation of these patients and compare them with patients without arterial hypertension.

NCT ID: NCT02508649 Terminated - Septic Shock Clinical Trials

Selepressin Evaluation Programme for Sepsis-Induced Shock - Adaptive Clinical Trial

SEPSIS-ACT
Start date: July 2015
Phase: Phase 2/Phase 3
Study type: Interventional

This is a double-blind, randomised, placebo-controlled, two-part adaptive clinical trial. The trial is designed to investigate the efficacy and safety of multiple dosing regimens of selepressin and to confirm the efficacy and safety of one dosing regimen in treatment of adult patients with septic shock requiring vasopressor.