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135 active trials for Septic Shock

Pilot Study on the Use of Hydrocortisone, Vitamin c and Tiamine in Patient With Sepsis and Septic Shock

Due to the high incidence, mortality and short and long term complications of sepsis and septic shock, it is necessary to look for strategies to try to minimize this impact.

Start: October 2018

Mortality Due to Septic Shock Associated With Thrombocytopenia

A prospective longitudinal study similar to the one performed by Claushuis and colleagues (2016) will be performed in order to further understand the epidemiology and clinical relationship between platelet levels and mortality secondary to septic shock in a different population. The primary objective is to compare the mortality due to septic shock between patients with thrombocytopenia and patients with normal platelet levels in the ICU of the General Hospital of León, Gto. The secondary objectives are to identify the association between mortality due to septic shock and mild, moderate and severe thrombocytopenia in patients admitted to the ICU at 30, 60 and 90 days. Research questions Is there an association between thrombocytopenia and mortality due to septic shock in patients admitted to the critical medicine service? Our hypotheses are that: 1. Mortality from septic shock and thrombocytopenia at 30, 60 and 90 days will be higher in patients with thrombocytopenia than in patients normal platelet counts. Is there an association between the degree of thrombocytopenia and mortality from septic shock in patients admitted to the critical medicine service? Our hypotheses are that: Mortality from septic shock and thrombocytopenia at 30, 60 and 90 days will be higher in patients with mild thrombocytopenia than in patients without thrombocytopenia. Mortality from septic shock and thrombocytopenia at 30, 60 and 90 days will be higher in patients with moderate thrombocytopenia than in patients without thrombocytopenia. Mortality from septic shock and thrombocytopenia at 30, 60 and 90 days will be higher in patients with severe thrombocytopenia than in patients without thrombocytopenia.

Start: August 2018

Plasmaexchange in Early Septic Shock

Sepsis is defined by the occurrence of a systemic inflammatory response syndrome (SIRS) in the context of infection. Unfortunately, its incidence appears to be rising, and the mortality of septic shock remains extraordinary high (> 60%). Death in sepsis arises from shock and multi organ dysfunction that are - at least in part - triggered by an inadequate response of the host's immune system to the infection. Given the injurious role of 1) this overwhelming immune response and 2) the consumption of protective plasmatic factors (e.g. vWF cleaving proteases, hemostatic factors etc.) while the disease is progressing the investigators hypothesize that early therapeutic plasma exchange (TPE) in the most severely ill individuals might improve hemodynamics, oxygenation and ultimately survival. This therapeutic strategy combines 2 major aspects in 1 procedure: 1. removal of harmful circulating molecules and 2. replacement of protective plasma proteins. The investigators designed the EXCHANGE trial to analyze in a randomized fashion the benefit of TPE as an add-on treatment to state of the art standard sepsis care. Only patients with early septic shock (< 12 hrs) and high catecholamine doses (noradrenaline > 0.4 ug/kg bodyweight/min) will be included. Those in the treatment group will receive 3 TPEs within three consecutive days. The primary outcome is 28-day all cause mortality. To show an assumed reduction from 60% to 45% in the experimental group, a sample size of 173 patients per group has been calculated. The overall sample size is therefore n=346. The recruitment period is 3 years (+3 months observation) and will be performed in 11 national centers in Germany. Secondary endpoints (including hemodynamics, oxygenation, coagulation, and microcirculation) will be assessed on day 1, 2, 3 before and after TPE and on day 4, 5, 7 and 14. Project management and data monitoring will be organized by the Hanover Clinical Trial Center and biostatistics including a web-based randomization will be performed by the Institute of biometrics (Prof. Koch) at Hannover Medical School. The investigators hope to demonstrate a potential benefit of an additive treatment approach to improve the outcome of patients suffering from an under-recognized but deadly disease.

Start: January 2016

Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination

The study aims at clarification of venous collapsibility measures with real venous flow measurements during dynamic maneuver testing fluid responsiveness in septic shock patients.

Start: September 2015

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

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.

Start: August 2019

REmote Ischemic COnditioning in Septic Shock

Septic shock remains a major public health problem in industrialized countries, with a mortality rate as high as 50%, largely related to multiple organ dysfunction. In addition to dysregulated inflammatory response, the pathophysiology of organ failures in septic shock involves ischemia-reperfusion processes. Remote ischemic conditioning is a therapeutic strategy for protecting organs against the detrimental effects of ischemia-reperfusion injury. The objective of the present study is to determine whether remote ischemic conditioning can limit the severity of organ failure in patients with septic shock.

Start: November 2017

Clinical Trial of Antioxidant Therapy in Patients With Septic Shock

Sepsis and septic shock are public health problems worldwide that represents an excessive cost for health systems. Despite the great technological and research advances, mortality can reach up to 80% in patients with multiple organ failure (FOM). Therapeutic studies focused on evaluating the usefulness of the use of antioxidants have shown different outcomes and results. This randomized clinical trial in patients with septic shock at two general intensive care units try to evaluate the usefulness of four different antioxidant therapies added to the conventional treatment, which includes: n-acetyl cysteine, vitamin C, vitamin E and melatonin. Measurement of parameters before and after treatment of oxidative stress includes nitrates and nitrites, lipid peroxidation, glutathione peroxidase, glutathione s transferase, extracellular activity of SOD, GSH concentration and evaluation of total antioxidant capacity. The investigators will also evaluate the clinical impact of antioxidant therapy with the SOFA score.

Start: July 2018

HindSight Phase II

Machine learning is a powerful method for creating clinical decision support (CDS) tools, but it requires training labels which reflect the desired alert behavior. In the Phase I work for this project, investigators have developed an encoding software called HindSight that examines discharged patients' electronic health records (EHR), identifies clinicians' sepsis treatment decisions and patient outcomes, and passes these labeled examples to an online algorithm for retraining InSight, a machine-learning-based CDS tool for real-time sepsis prediction. Although HindSight has been shown to be successful in improving the performance of InSight in retrospective work, it has yet to be validated in prospective settings; therefore, in this project, the clinical utility of HindSight will be assessed through a multicenter randomized controlled trial (RCT).

Start: January 2020

TRANSfusion in Patients With Onco-hematological Malignancies ResusciTated From Septic Shock

Septic shock is a frequent complication associated with high mortality in patients with malignancies. The best transfusion strategy (restrictive or liberal) for the resuscitation of septic shock remains a controversial issue, in relation with potentially discrepant goals of tissue oxygenation and transfusion sparing. In this study, the investigators propose to address the efficacy of two RBC transfusion strategies (liberal or restrictive) in restoring appropriate tissue oxygenation as well as their tolerance. The investigators designed a prospective randomized multicenter trial aimed at comparing liberal and restrictive RBC transfusion strategies applied during the first 48 hours of resuscitation in cancer patients with septic shock and anemia.

Start: March 2019

Quantification of Bacterial DNA in Sepsis

The purpose of this study is to evaluate whether bacterial DNA clearance measured with droplet digital Polymerase Chain Reaction (ddPCR) can be used as a measure of bacterial load in septic intensive care patients. Furthermore, the aim is to examine a possible relation between clearance of bacterial DNA and clinical outcome in the septic patient, and the relationship between concentration of beta-lactam antibiotics and the clearance of bacterial DNA.

Start: January 2019

Subpopulation-Specific Sepsis Identification Using Machine Learning

The focus of this study will be to conduct a prospective, randomized controlled trial (RCT) at Cape Regional Medical Center (CRMC), Oroville Hospital (OH), and UCSF Medical Center (UCSF) in which a subpopulation-optimized algorithm will be applied to EHR data for the detection of severe sepsis. For patients determined to have a high risk of severe sepsis, the algorithm will generate automated voice, telephone notification to nursing staff at CRMC, OH, and UCSF. The algorithm's performance will be measured by analysis of the primary endpoint, in-hospital SIRS-based mortality. The secondary endpoints will be in-hospital severe sepsis/shock-coded mortality, SIRS-based hospital length of stay, and severe sepsis/shock-coded hospital length of stay.

Start: December 2020

Unsupervised Machine Learning for Clustering of Septic Patients to Determine Optimal Treatment

The focus of this study will be to conduct a prospective, randomized controlled trial (RCT) at Cape Regional Medical Center (CRMC), Oroville Hospital (OH), and UCSF Medical Center (UCSF) in which a fluid treatment-specific algorithm will be applied to EHR data for the detection of severe sepsis. For patients determined to have a high risk of severe sepsis, the algorithm will generate automated voice, telephone notification to nursing staff at CRMC, OH, and UCSF. The algorithm's performance will be measured by analysis of the primary endpoint, reductions in in-hospital mortality.

Start: July 2020

Gram Type Infection-Specific Sepsis Identification Using Machine Learning

The focus of this study will be to conduct a prospective, randomized controlled trial (RCT) at Cape Regional Medical Center (CRMC), Oroville Hospital (OH), and UCSF Medical Center (UCSF) in which a Gram type infection-specific algorithm will be applied to EHR data for the detection of severe sepsis. For patients determined to have a high risk of severe sepsis, the algorithm will generate automated voice, telephone notification to nursing staff at CRMC, OH, and UCSF. The algorithm's performance will be measured by analysis of the primary endpoint, time to antibiotic administration. The secondary endpoint will be reduction in the administration of unnecessary antibiotics, which includes reductions in secondary antibiotics and reductions in total time on antibiotics.

Start: May 2022

Control Versus Liberal Cardiac Frequency in Patients in Sepse With Atrial Fibrillation of High Ventricular Response

Amiodarone is considered the medicine of choice in heart rate control in critically ill patients with atrial fibrillation with high ventricular response. However, a recent retrospective study showed a greater number of events in critical patients in whom there was an attempt to control versus in which there was no. Therefore, the prospective and randomized comparative use of amiodarone in this group of patients has not yet been described. The aim of this study was to evaluate the safety of the use of amiodarone (restricted group) versus placebo (liberal group) in heart rate control in atrial fibrillation with high ventricular response in patients with sepsis and vasopressor cardiovascular dysfunction. For this, a unicentric, randomized, blind and prospective study will be performed, in which the restrictive versus liberal strategy is performed in a comparative way. Hospital data (test results, medical evolutions complications) of patients will be analyzed to calculate safety and effectiveness. Expected results: The liberal strategy is superior to the restrictive strategy and causes fewer adverse events.

Start: December 2018

A Study of LJPC-501 in Paediatric Patients With Hypotension Associated With Distributive or Vasodilatory Shock

The objective of this study is to evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP) as assessed by standard of care vasopressor dose reduction in pediatric patients with catecholamine-resistant hypotension (CRH). In addition, this study will evaluate the safety and tolerability of LJPC-501 in pediatric patients, evaluate changes in catecholamine and other vasopressor doses over time, evaluate the change in MAP over time, and the change in Pediatric Logistic Organ Dysfunction-2 (PELOD-2) scores.

Start: August 2018