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Shock, Septic clinical trials

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NCT ID: NCT03749525 Not yet recruiting - Septic Shock Clinical Trials

Shenfu Injection Improves Arterial Vascular Reactivity

Start date: December 1, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Septic shock is a common and critical illness in ICU.The vascular dysfunction of septic shock is manifested by vasospasm and decreased arterial vascular reactivity . Current studies have shown that the main mechanisms of vasospasm and decreased arterial vascular reactivity include increased vasospasm and down-regulation of receptor sensitivity , and eventually cause a decrease in vascular smooth muscle contractility.A large number of vasodilators are released during septic shock, in which inducible nitric oxide synthase (iNOS) and prostacyclin (PGI2) are important vasodilators leading to septic shock vasospasm.At present, vasoactive drugs are widely used in clinically to improve vascular tone and are important means of circulation support. However, when the infection is heavier, the reactivity of the blood vessels to the vasoactive drugs is lowered, and it is difficult for the large doses of the vasoactive drugs to maintain the circulation stability. At this time, the use of vasoactive drugs alone does not benefit patients with septic shock and may require the combination of other drugs.From the perspective of Chinese medicine, shock is a disease of yang. Shenfu injection has the effect of rejuvenating the yang and replenishing the qi. This trial was designed to give patients with septic shock the use of Shenfu injection to determine the specific effects of Shenfu injection on vascular reactivity in patients with septic shock.

NCT ID: NCT03748537 Completed - Sepsis Clinical Trials

Mitochondrial Function in Septic Patients

MtiSS
Start date: January 1, 2017
Phase: N/A
Study type: Interventional

Aim #1 To investigate the prevalence, risk and correlation of the level of sepsis with mitochondrial dysfunction in sepsis patients Aim 1.1 To investigate the prevalence of mitochondria dysfunction among sepsis patients Aim 1.2 To investigate the risk associated with mitochondrial dysfunction in sepsis patients. Aim 1.3 To investigate the association between sepsis severity (SOFA scoring system) and the degree of mitochondrial dysfunction Aim #2 To investigate the association of mitochondrial dysfunction in sepsis with ScvO2, lactate and ∆PCO2 Aim 3.1 To investigate the therapeutic efficacy of steroids on the improvement mitochondrial function in sepsis patients Aim 3.2. To investigate the efficacy of steroids on the reduction mortality rate in sepsis patients with norepinephrine-resistant hypotension

NCT ID: NCT03727243 Recruiting - Sepsis Clinical Trials

Molecular Diagnosis and Risk Stratification of Sepsis in India

MARS-India
Start date: December 6, 2018
Phase:
Study type: Observational

Background: Globally, sepsis is common with an estimated population incidence of 437 cases per 100, 000 person-years and acute mortality of 26%, one of the few major medical conditions whose incidence and resulting mortality continues to rise. However, true burden is likely significantly higher as a recent meta- analysis could find no data from LMIC where 87% of the world's population resides. Objective: Generate new knowledge that will eventually provide rapid and accurate information about an individual patient suffering from sepsis (or critical illness), including which type of microorganism is responsible for the infection and the severity and stage of the patient's immune response. Methods: MARS-India will be a prospective longitudinal, single-centre observational study, conducted in mixed ICU's of a >2000 bedded tertiary teaching hospital in Manipal, India. The investigators will recruit to three groups- sex and age-matched healthy volunteers (n=150) and patients diagnosed with sepsis/septic shock or non-infectious ICU admissions such as severe trauma, severe burns and patients admitted to ICU after major surgery (n=400). The investigators have optimised a workflow to follow and describe the immunoinflammatory status of septic patients (as well as severe trauma/burn and major surgery) during the first 6 months after their initial injury. At fixed time points the investigators will collect blood in PaxGene, heparin, citrate and EDTA tubes in addition to routine bloods and microbiological samples. Rectal swabs and stool will also be taken for microbiome analysis. Immune functional tests will be performed to determine whole-blood cytokine/chemokine production in response to ex-vivo stimulation using an 8-panel assay. Additionally, complete immunophenotyping using flow cytometry including HLA-DR expression and lymphocyte subsets will be obtained.

NCT ID: NCT03716895 Not yet recruiting - Septic Shock Clinical Trials

Severe Septic Shock Complications

Start date: December 2018
Phase:
Study type: Observational [Patient Registry]

Adults older than 18 years old, admitted to the ICU with a Severe Septic Shock, requiring Norepinephrine at more than 0.25mcg/kg/min, who have signed informed consent form, will be consecutively included, from december 2018 to december 2019. The primary goal is to look for risk factors associated with an increased in lactate clearance Secondary goals are the following: 1. To look for risk factors associated with an increase risk of Hospital and ICU length of stay. 2. To look for risk factors associated with an increase risk of Acute Kidney Injury. 3. To look for risk factors associated with a decrease in days alive and free of Mechanical Ventilation, Vasopressors and Renal Replacement Therapy. 4. To look for risk factors associated with a decrease in Ventilator-free days. 5. To look for risk factors associated with a decrease in Vasopressor-free days. 6. To look for risk factors associated with an increase risk of in-hospital mortality. 7. To look for risk factors associated with an increase risk of Myocardial Infarction and myocardial injury. 8. To look for risk factors associated with an increase risk of Acute Respiratory Distress Syndrome. 9. To compare and validate different risk scores in our cohort.

NCT ID: NCT03716310 Completed - Sepsis Clinical Trials

Platelet Reactivity in Septic Shock

Start date: April 1, 2017
Phase:
Study type: Observational

Coagulation disorders and thrombocytopenia are common in patients with septic shock. Despite the clinical relevance of sepsis-induced thrombocytopenia, few studies have focused on the prediction of thrombocytopenia in this setting. The aim of this study was to evaluate whether platelets aggregometry and markers of platelets activation, such as mean platelet volume or platelet volume distribution width, could predict sepsis-induced thrombocytopenia in patients with septic shock and normal platelet count on the day of diagnosis.

NCT ID: NCT03715556 Not yet recruiting - Atrial Fibrillation Clinical Trials

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

FAARV
Start date: December 1, 2018
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT03713307 Recruiting - Acute Kidney Injury Clinical Trials

Macro and Micro Haemodynamic Responses to Shock in the Renal and Systemic - MICROSHOCK - RENAL

Start date: November 27, 2018
Phase:
Study type: Observational

An observational study of the state of the renal and systemic circulations in patients with early septic shock. Both macro and microvascular parameters will be assessed using echocardiography, sublingual incident dark field video-microscopy and renal contrast enhanced ultrasound. Patients will be categorised by KDIGO degree of kidney injury at Day 7 and stratified. Haemodynamic and perfusion based variables over time for these groups will be compared to assess the impact of changes in same on the development of AKI. Lab based work to quantify renal injury biomarkers will also be undertaken.

NCT ID: NCT03710187 Completed - Septic Shock Clinical Trials

HCT+F vs. HCT Alone in Critically Ill Medical Septic Shock Patients

Start date: November 5, 2018
Phase: Phase 2
Study type: Interventional

This study will be conducted as a single-center, prospective, open-label, randomized trial that will evaluate adult patients admitted with septic shock to the medical critical care unit (MCC). The objective of the study is to determine if the use of hydrocortisone plus fludrocortisone is associated with a faster resolution of shock (defined as 24 hours vasopressor free) when compared to the use of hydrocortisone alone in medical, critically ill septic shock patients.

NCT ID: NCT03708796 Completed - Sepsis Clinical Trials

DIAGNOSis of Infection in Emergency Department

DIAGNOSED
Start date: April 9, 2018
Phase:
Study type: Observational

Septic pathology is an extremely frequent reason for consultation in our emergency services, with an annual incidence of severe forms between 50 to 95 cases per 100,000 inhabitants and a constant increase estimated at 9% per year. Diagnosing these patients early and precisely is a major challenge for the clinician, as this diagnosis will lead to more or less aggressive medical management. The criteria of S.I.R.S, used to define and to sort patients in sepsis according to the old definition, were completely abandoned in the last recommendations for lack of specificity but also of sensitivity. The latest recommendations suggest using another score, the "Quick Sepsis Related Organ Failure Assesment (qSOFA) score", in order to early detect septic patients at risk of poor progress. However, the recent literature highlights a very low sensitivity of the qSOFA score for the screening of septic patients, ranging from 30 to 60% according to the studies. In addition to qSOFA, other scores are described in the literature with apparently higher sensitivity, and thus seem more suitable for our daily practice. Among them is the NEWS score or the RETTS score. Each of these scores is again based upon the values of vital signs recorded as soon as the patient arrives in the emergency department. To date, very few studies have been interested, in a prospective way, in the sensitivity and the specificity of these different scores to diagnose the "infected" patients in the emergency departments. Therefore a non-interventional, prospective, multicenter cohort study is carried out here, in order to be able to compare, on the same cohort of patients admitted into emergency services, the diagnostic performance of these different scores with respect to the presence or absence of an infection. The aim of this study is to define the best clinical score to use in emergency medicine to quickly diagnose the infected patients, and offer them the best medical care.

NCT ID: NCT03706053 Terminated - Septic Shock Clinical Trials

Midodrine Use in Septic Shock

Start date: November 5, 2018
Phase: Phase 3
Study type: Interventional

The investigators aim to perform a randomized, double-blind, placebo-controlled trial to investigate the efficacy of midodrine in decreasing time to IV vasopressor liberation in patients with septic shock.