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Shock, Septic clinical trials

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NCT ID: NCT04027699 Completed - Clinical trials for Severe Sepsis or Septic Shock in Pediatric Intensive Care Unit

Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock

PRECISE
Start date: February 23, 2021
Phase: N/A
Study type: Interventional

Severe sepsis and septic shock remain of particular gravity in children with a current mortality of about 20 % , despite the international prevention campaigns " survival sepsis campaign ". Septic shock associates a macrocirculatory and a microcirculatory dysfunction. The volume expansion remains the treatment of severe sepsis at the initial phase supplemented by the use of vasopressors and / or inotropes. Nevertheless , it is essential to predict the fluid responsiveness after volemic expansion because fluid overload is associated with an increased morbidity in children. In studies , the volume expansion is considered effective if it allows an increase in cardiac output of more than 15 % compared to the basal level. However, their conditions of use remain very restrictive and not applicable to most of our patients ( tidal volume ≥ 7ml / kg , PEEP sufficient , absence of cardiac arrhythmia and effective sedation ) . To date , no index can be used for all patients with invasive mechanical ventilation. It therefore seems appropriate to develop new tests to predict the response to volume expansion in children with septic shock hospitalized in pediatric intensive care. A recent study has validated a test to predict the response to volume expansion in adults: injection of a mini-bolus of 50 ml of saline over 10s. The aim of the study is to evaluate the effect of mini bolus fluid to predict response to fluid expansion in pediatric septic shock.

NCT ID: NCT04015752 Not yet recruiting - Sepsis Clinical Trials

Sepsis in ICU:Causes and Outcomes of Sepsis in Diabetics Versus Non Diabetics in Assiut University Hospital

Start date: August 2019
Phase:
Study type: Observational

Clarify different causes of sepsis in patients admitted to ICU . as well asCompare causes and outcomes of sepsis between diabetics versus non diabetics . 3.Screening for the commonest organism causing sepsis in critically ill patients. Determine better protocol therapy that help in decreasing mortality and morbidity in patients with sepsis in ICU.

NCT ID: NCT04013269 Recruiting - Septic Shock Clinical Trials

Adjuvant Therapy With CytoSorb in Refractory Septic Shock

ACYSS
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

This prospective randomized single center study investigates to what extent the removal of elevated cytokine levels by hemoadsorption has a positive effect on the treatment of patients in septic shock by stabilizing the circulatory situation.

NCT ID: NCT03989609 Completed - Septic Shock Clinical Trials

Dexmedetomidine in Modifying Immune Paralysis In Patient With Septic Shock

RODIS
Start date: June 20, 2019
Phase: Phase 2
Study type: Interventional

in this study the investigators aim to assess the role of using dexmedetomidine as sedative in septic shock patients in comparison with midazolam. The investigators aim to assess the effect on immune response and inflammatory mediators and effect on vasopressors.

NCT ID: NCT03987048 Completed - Septic Shock Clinical Trials

Cirrhotic Patients With Septic Shock

Start date: April 2014
Phase:
Study type: Observational

Cirrhotic patients have a poor outcome in intensive care unit (ICU). Septic shock is a leading cause of ICU admission and death in this specific population. We performed a monocentric retrospective study; all cirrhotic patients admitted in the ICU with septic shock from 2002 to 2013 were included. The aim of the study was to identify prognostic factors for both short- and long-term mortality in these patients. Demographic, clinical and biological data, organ supports, and outcomes were collected. Univariate and multivariate analysis were carried out regarding both ICU and one-year mortality.

NCT ID: NCT03977688 Completed - Clinical trials for Severe Sepsis With Septic Shock

Evaluating a CytoSorb Score in Septic Shock

ECSISS
Start date: March 1, 2019
Phase:
Study type: Observational

Systemic hyperinflammatory states, e.g. triggered by infection/sepsis, represent a major challenge for modern medicine. After an initially localized onset, inflammation can extend to an excessive, uncontrolled inflammatory reaction affecting the entire body and can trigger circulatory failure with subsequent irreversible multiple organ failure. Despite all the medical advances made in recent years, sepsis continues to be a substantial problem, as almost all therapeutic approaches have failed to prove their efficacy to date. Mortality in this clinical entity thus remains extremely high. In Germany alone, more than 100,000 people suffer from sepsis or septic shock every year, nearly half of whom die despite optimal therapy. Thus, sepsis is the third most common cause of death, has major importance both from a medical but also from an economical viewpoint, and approaches that could contribute to its successful treatment need to be further developed and explored. If a patient experiences the spread of bacteria or their constituents in the blood stream due to an uncontrolled source of infection, the result is a deliberately triggered physiological defense reaction of the body. In many patients, however, there is a pathological dysregulation of these mechanisms, in a way that the defense reaction goes far beyond the physiological level required, resulting in an excessive immune response of the body, which is mainly facilitated by inflammatory mediators such as cytokines and chemokines. The immune response spreads throughout the body and also dissipates into organs unaffected by the original infection. In cases of such unwanted overshooting immune responses, an attempt to regain control of the described deleterious systemic events seems reasonable by removing the excess amount of cytokines from the blood, thus preventing or treating organ failure. In this context, current therapeutic approaches increasingly focus on the elimination of inflammatory mediators. In recent years, hemoadsorption, using a new adsorber (CytoSorb), has been used to treat sepsis and other conditions of hyperinflammation. The advantage of this therapeutic principle is that a wide range of inflammatory mediators are removed. In conjunction with the enormous elimination capacity, the effective and rapid reduction of mediators can be achieved. To date, there have been more than 61,000 treatments using this procedure worldwide without device-related side effects being reported. The investigators have been treating patients with this procedure for over 5 years with consistently very favorable results. Therefore, the investigators would like to expand and deepen their observations with the proposed project.

NCT ID: NCT03974386 Completed - Septic Shock Clinical Trials

Effects of Endotoxin Absorption and Cytokine Removal Hemofilter on Severe Septic Shock

Start date: July 1, 2019
Phase: N/A
Study type: Interventional

In recent years, many studies have pointed out that bacterial toxin and cytokine storm are the main causes of shock and multiple organ failure in patients with sepsis. Endotoxin is the main vehicle for systemic inflammatory reaction caused by gram-negative bacteria which induce sepsis. Endotoxin binds to Toll- Like receptor 4 (TLR4) trigger a cytokine storm. The amount of endotoxin is associated with shock, insufficient intestinal perfusion, and poor prognosis. Therefore, clinicians try to use various methods to antagonize the action of endotoxin, which can reduce the cytokine storm and inflammatory response to improve the prognosis of sepsis. Continuous venous venous hemofiltration plays a role in blood purification in septic shock. With different hemofiltration filters, it has different effects. By removing the inflammatory mediators caused by bacterial toxins and cytokines, shock can be improved. The study plans to receive patients with septic shock and use a hemofiltration filter that adsorbs endotoxin and removes cytokines (oXiris, Baxter Healthcare) to perform continuous venous venous hemofiltration in addition to basic septic shock resuscitation. The effect on the concentration of cytokines in the blood, the infusion dose of inotropics, the fluid balances, and the degree of organ damage was evaluated. It is hoped that the results of this pilot study can lead us to subsequent randomized clinical trials to explore whether this filter can improve the prognosis of septic shock patients.

NCT ID: NCT03966664 Recruiting - Sepsis Clinical Trials

Determination of the Dissociation Constant (Ka) of Plasma and Whole Blood in Septic Patients

ENTERPRISE
Start date: June 3, 2019
Phase:
Study type: Observational

Alterations of acid-base equilibrium are very common in critically ill patients and understanding their pathophysiology can be important to improve clinical treatment.

NCT ID: NCT03961594 Recruiting - Septic Shock Clinical Trials

Evaluation of New Hemodynamic Indices

EVOLVE
Start date: July 19, 2018
Phase: N/A
Study type: Interventional

The objective is to determine the sensitivity and specificity via Receiver Operating Characteristic (ROC) curve of Global Longitudinal Strain (GLS) The secondary objectives are the same for the change in the amount of carbon dioxide exhaled (ΔEtCO2) and dynamic arterial elastance (Eadyn). it will also determine the sensitivity and specificity of these indices, either individually or combined to determine persistent responders to volemic expansion.

NCT ID: NCT03953677 Terminated - Septic Shock Clinical Trials

Evaluation of the Effect of Dexmedetomidine on Phenylephrine Response During Refractory Septic Shock

Adress-Pilot
Start date: October 27, 2019
Phase: Phase 3
Study type: Interventional

Septic shock is common in patients admitted to intensive care and hospital mortality occurs in close to 50% of these patients. In half of the cases, death occurs within the first 72 hours in a context of multiple organ failure that does not respond to conventional therapies, particularly circulatory therapies, despite increasing doses of catecholamines. Vasopressor resistance in septic patients defines refractory septic shock. In one study (Conrad et al. 2015), the increase in blood pressure observed with an infusion of increasing doses of phenylephrine (dose-response curve) made it possible to quickly and clearly identify patients resistant to vasopressors at a high risk of death by refractory shock (ROC AUC 0.92). This resistance is due in particular to a downregulation of α1 adrenergic receptors, linked to sympathetic hyper activation associated with septic shock. To date, there is no validated therapy in this situation. However, experimental data have shown that the administration of α2 agonists, usually used for their sedative (dexmedetomidine) or anti-hypertensive (clonidine) effect, normalizes sympathetic activity towards basal values. In animals, α2 agonists restore the sensitivity of alpha1 adrenergic receptors, resulting in improved vasopressor sensitivity and survival. In humans, a beneficial effect on mortality was suggested in the first trial testing dexmedetomidine in septic patients in 2017. This effect was observed especially in the most severe patients, suggesting a restoration of sensitivity to vasopressors. The hypothesis is that the administration of dexmedetomidine in patients in refractory septic shock may improve response to phenylephrine and decrease resistance to vasopressors. This pilot study could lay the foundation for a randomized controlled trial.