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Shock, Septic clinical trials

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NCT ID: NCT03700346 Completed - Septic Shock Clinical Trials

Muscle Lactate and Lactate to Pyruvate Ratio Clearance in Septic Shock Patients

ClMLsepsis
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

We conducted this study aiming to assess the performance of muscle Lactate and lactate to pyruvate (L/P) ratio clearance in predicting mortality in septic shock patients by using microdialysis.

NCT ID: NCT03685214 Recruiting - Sepsis Clinical Trials

Comparison of Balanced Crystalloids and Normal Saline in Septic Patients

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

In this prospective randomized controlled trial, investigators attempt to study the effects of acetated Ringer's solution on the prognosis and renal function of patients with sepsis in intensive care unit compared with normal saline, and provide evidence for current fluid resuscitation strategies for sepsis.

NCT ID: NCT03683329 Recruiting - Cancer Clinical Trials

Antibiotic De-escalation in Onco-hematology Patients for Sepsis or Septic Shock

DéPOH
Start date: November 26, 2018
Phase: Phase 3
Study type: Interventional

De-escalation aims at reducing the use of broad-spectrum antibiotics and therefore the emergence of multidrug-resistant (MDR) pathogens. Observational studies suggested that this strategy seems to be safe. However, there is no adequate, direct evidence showing de-escalation of antimicrobial agents to be effective and safe for onco-hematology patients with sepsis or septic shock. Thus, randomized clinical trials are needed for testing the safety and efficiency of de-escalation of antimicrobial therapy. The investigator's hypothesis is that de-escalation of empirical antimicrobial therapy in onco-hematology patients with sepsis or septic shock is noninferior to the continuation of empirical antimicrobial therapy. The first aim of the study is to demonstrate that de-escalation is noninferior to the continuation of broad-spectrum antibiotics in terms of hospital mortality. The secondary aims are to compare the two strategies in terms of mortality, duration of antimicrobial therapy, durations of mechanical ventilation, vasopressor use, numbers of superinfections, organ failure. Antimicrobial de-escalation (ADE) of antimicrobial therapy is a strategy proposed to allow for the rational use of broad-spectrum antimicrobial therapy as the empiric treatment for infections and minimize the overall exposure to these broad-spectrum agents. The need for prompt, effective antimicrobial therapy for patients with known or suspected infections is widely accepted. This principle leads to the use of very broad-spectrum antimicrobial therapy to increase the odds that all suspected potential pathogens are adequately treated. However, the potential drawback is selection of multidrug-resistant (MDR) organisms. ADE is widely recommended in the management of antimicrobial therapy in intensive care unit (ICU) patients. The Surviving Sepsis Campaign guidelines describe and recommend the process for selecting antimicrobial therapy as commencement of antimicrobials within the first hour, antimicrobial therapy broad enough to cover all likely pathogens, and daily reassessment for potential ADE. To date, no randomized study assessing this strategy is available for this specific population of cancer critically ill patients. In a recent systematic review based on 13 observational studies and one randomized controlled trial, the authors conclude that the equipoise remains and a large randomized trial is required to assess the effect of the antibiotics de-escalation strategy on the bacterial ecosystem, on MDR carriage, and on patient outcomes.

NCT ID: NCT03682003 Active, not recruiting - Clinical trials for Severe Sepsis or Septic Shock

Hepcidin: a Prognostic Marker of Morbidity and Mortality in Severe Sepsis?

HEP-SEPSIS
Start date: October 1, 2014
Phase:
Study type: Observational

Many biomarkers have been evaluated in sepsis, especially for prognostic purposes, but none has yet been shown to have sufficient sensitivity or specificity for routine use in clinical practice. However, highlighting a biomarker facilitating the evaluation of the severity of sepsis remains relevant in a pathology where survival is largely conditioned by the initiation of an early and adapted treatment. Recent evidence suggests that hepcidin, which is the key hormone for systemic regulation of iron metabolism, may be an interesting prognostic biomarker. The synthesis of this peptide is regulated by the iron stocks of the body, erythropoiesis, but also inflammation. The mechanisms inducing the expression of hepcidin during inflammation are multiple: interleukin-6 (IL-6) in particular, pro-inflammatory cytokine is a strong inducer of hepcidin. In addition, its expression is increased by the effect of lipopolysaccharide via Toll-like receptors . In septic patients, elevated levels of hepcidin or pro-hepcidin have been reported . A new role for hepcidin in the control of inflammatory and / or immune response has recently been reported. Thus, in a model of murine septic shock, the deleterious character of a lack of expression of hepcidin could be demonstrated . In humans, hepcidinemia has been shown to be a predictive factor in the development of immunotolerance in hepatic transplant patients. Hepcidin therefore plays a major role in the regulation of the inflammatory and / or immune response and in particular during sepsis. The investigators therefore hypothesize that hepcidin could be the marker of an adverse prognosis in septic patients expressing this

NCT ID: NCT03677102 Recruiting - Clinical trials for Sepsis, Septic Shock

Fluids in Septic Shock (FISSH)

FISSH
Start date: September 9, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Despite evidence of the physiologic benefits and possible lower mortality associated with low chloride solutions, normal saline remains the most wildly used fluid in the world. Given uncertainty about the impact of lower chloride versus higher chloride solutions on mortality, it is unlikely that clinical practice will change without new and direct randomized controlled trial (RCT) evidence. Editorials published in leading critical care journals have called for RCT's to address this important clinical question. This trial will directly compare low chloride versus normal chloride for resuscitation in septic shock on patient-important outcomes such as mortality and AKI.

NCT ID: NCT03673891 Withdrawn - Sepsis Clinical Trials

Evaluation of Fluid Infusion With LifeFlow for Patients With Suspected Septic Shock

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

The LifeFlow rapid infusion device is a handheld manually-operated device that has been shown in early trials to increase the rate of bolus fluid infusion up to 3 times the rate of delivery attributed to conventional rapid infusion devices. The device addresses other technical barriers to fluid resuscitation, including reducing complexity and provider fatigue. LifeFlow utilizes standard IV or intraosseous (IO) vascular access devices to quickly and efficiently deliver appropriate volumes of crystalloid fluid to patients during emergent fluid resuscitation. The purpose of this study is to determine if intravenous fluids can be administered more rapidly and efficiently with the use of the LifeFlow rapid infusion device compared to the current standard techniques in adult patients who present to the Emergency Department with septic shock.

NCT ID: NCT03668236 Active, not recruiting - Septic Shock Clinical Trials

The Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care Trial

CLASSIC
Start date: November 27, 2018
Phase: Phase 4
Study type: Interventional

The purpose of this trial is to assess patient important benefits and harms of IV fluid restriction vs. standard care fluid therapy in patients with septic shock.

NCT ID: NCT03663192 Completed - Shock, Septic Clinical Trials

Strain Echocardiography During Septic Shock : an Observational Pilot Study

Sepsistrain
Start date: February 22, 2016
Phase:
Study type: Observational

The mortality of septic shock remains high nowadays despite a trend toward improvement.Septic cardiomyopathy has been reported in most experimental models of sepsis shock. Its relationship with mortality is unclear. A decrease in mortality have been reported in patients with decreased left ventricular ejection fraction (LVEF), but a recent meta-analysis did not support such results. In fact, it appears that high LVEF are linked to profound vasoplegia which is associated to bad outcome. In the other hand, alterations of Strain echocardiography, a new method allowing a more sensitive evaluation of heart function, have been associated with a worse outcome in sepsis patients. Only few studies have examined echocardiographic strain during sepsis shock in human, and its natural history was only described in pigs. Moreover, the right ventricular strain was reported only by Orde et al whereas the evolution of strain during fluid infusion have never been studied. The aim of the present study is to describe the natural history of echocardiographic strain during sepsis shock and to determine its prognosis value.

NCT ID: NCT03661268 Recruiting - Septic Shock Clinical Trials

The Effect of Rapid Fluid Challenge Under Pulmonary Artery Catheter Monitoring on Physiological Indexes of Patients With Septic Shock

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Fluid challenge is often carried out in septic shock patients. Its responsiveness usually requires invasive monitoring. The pulmonary artery catheter(PAC) is the most effective means of monitoring.To use non-invasive methods is very tempting. Investigators hypothesize that venous-to-arterial carbon dioxide difference,venous-to-arterial carbon oxygen difference, central venous-arterial carbon dioxide to arterial-venous oxygen content ratio and Central Venous SO2 variations provides feasible estimation on fluid responsiveness in septic shock patients.

NCT ID: NCT03655626 Completed - Sepsis Clinical Trials

Implementation and Evaluations of Sepsis Watch

Start date: November 5, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to study the implementation and impact of an early warning system to detect and treat sepsis in the emergency room. We are observing the implementation of a Sepsis Machine Learning Model on all Adult patients. All data (observations field notes, interview recording & transcripts, and survey responses) will be stored on HIPAA-compliant Duke servers behind the Duke firewall, and requiring password-protected user authentication to access. The risk to patients is minimal. The two risks to interviewed clinical staff we have identified involve loss of work time and anonymity.