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Shock, Septic clinical trials

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NCT ID: NCT05001854 Not yet recruiting - Septic Shock Clinical Trials

Hemodynamics Effects of Fludrocortisone on the Pressor Response to Noradrenaline Septic Shock Patients

FLUDROSEPSIS
Start date: August 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The benefit of low-dose steroids in septic shock is still debated today, especially with mineralocorticoids. Fludrocortisone is a synthetic mineralocorticoid, an analogue of aldosterone, which has shown, in combination with hydrocortisone, a favorable effect on the mortality of septic shock patients with relative adrenal insufficiency. In a previous study in healthy volunteers, we showed for the first time that fludrocortisone at a dose of 400 μg per day significantly improved the pressor response to phenylephrine. These results confirm the observations reported in rats with endotoxin shock, where fludrocortisone was shown to significantly increase blood pressure and contractile response to phenylephrine. These encouraging results argue for a potential vascular beneficial effect of fludrocortisone and need to be confirmed in a population of septic shock patients. In this context, we aimed to evaluate the effect of oral administration of 100 μg every 6 hours of fludrocortisone on vascular responsiveness to noradrenaline in septic shock patients.

NCT ID: NCT04999137 Recruiting - HIV Clinical Trials

Evaluation of Safety and Dosing of a Vitamin C Bundle for Sepsis Treatment in Africa

REVISTA-DOSE
Start date: September 1, 2021
Phase: Phase 2
Study type: Interventional

Open-label phase 2a Randomized Controlled Trial (RCT) assessing the pharmacokinetics of two different doses of intravenous vitamin C given alongside vitamin B1 in adult medical patients with sepsis and hypotension.

NCT ID: NCT04997421 Recruiting - Acute Kidney Injury Clinical Trials

Safety and Efficacy of HA380 Hemoadsorption in Patients With Septic Shock

HEMOX-HDF
Start date: June 10, 2021
Phase: N/A
Study type: Interventional

Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. Intensive care unit (ICU) mortality in patients with septic shock and acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT) remains high and approximates 50-60%. Sepsis is the leading etiology for AKI and CRRT requirement in ICU patients. In septic shock, the dysregulated host response to infectious pathogens leads to a cytokine storm with uncontrolled production and release of humoral pro-inflammatory mediators. These pro-inflammatory mediators and cytokines exert cellular toxicity and promote the development of organ dysfunction and increased mortality. In addition to treating AKI, CRRT techniques can be employed for adsorption of inflammatory mediators extracorporally using specially developed adsorption membranes, hemoperfusion sorbent cartridges or columns. Several methods and devices, such as Oxiris®-AN69 membrane, CytoSorb® cytokine hemoadsorption and polymyxin B (Toraymyxin) endotoxin adsorption and plasmapheresis have been evaluated in small study series but to date the data on outcome benefits remains controversial. HA380 (Jafron Biomedical Co , Ltd, Zhuhai, China) is a CE-labeled hemoadsorption cartridge developed to treat patients with septic shock. It contains hemo-compatible, porous polymeric beads that adsorp cytokines and mid-molecular weight toxins on their surface. The cytokines absorved using this cartridge are IL-1, IL-6, IL-8, IL-10 in addition to TNF-α8. Therefore, this study aims to examine the potential effects of cytokine adsorption using HA380 in addition to hemodiafiltration with the Oxiris®-AN69 membrane on ICU- and 90-day mortality in patients with septic shock and AKI.

NCT ID: NCT04991376 Active, not recruiting - Sepsis Clinical Trials

Specific miRNAs in Sepsis and Nephrotoxic Antibiotic Treatment

Start date: May 2, 2019
Phase:
Study type: Observational

Critically ill patients are prone to develop acute kidney injury due to sepsis itself and by administration of potentially nephrotoxic antibiotic treatment (vancomycin or gentamicin). Blood-specific miRNA levels associated with renal tubular damage change in patients treated with vancomycin or gentamicin compared to septic patients treated with other antimicrobials.

NCT ID: NCT04970602 Active, not recruiting - Septic Shock Clinical Trials

The Effect of Early Use of Methylene Blue on Hemodynamics in Septic Shock

Start date: June 20, 2021
Phase: N/A
Study type: Interventional

This study will include patients requiring high dose of norepinephrine (NA) to maintain blood pressure after fluid resuscitation. The patients will be randomized into two groups, the study protocol is early combined application of methylene blue. The primary outcome is Sequential Organ Failure Assessment (SOFA) score 72 hours after admission. Second outcome includes duration of shock, length of intensive care unit (ICU) hospitalization and so on. To explore the underlying mechanism, the changes of sublingual microcirculation before and after vasopressor combination will be collected, also is the global longitudinal strain of left ventricle.

NCT ID: NCT04963920 Not yet recruiting - Septic Shock Clinical Trials

A RCT to Assess the Performance of CytoSorb for Shock Reversal in Patients With Vasoplegic Septic Shock

PROCYSS
Start date: September 2021
Phase: N/A
Study type: Interventional

To assess the performance of the CytoSorb® 300 mL device for shock reversal in patients with vasoplegic septic shock.

NCT ID: NCT04963686 Recruiting - Septic Shock Clinical Trials

Simplified Assessment of Left Ventricular Systolic Function in Septic Shock Patients

MAPSE
Start date: August 1, 2021
Phase:
Study type: Observational

The assessment of left ventricular systolic function is based on the measurement of left ventricular ejection function (LVEF) by the Simpson biplane method. More recently, left ventricular global longitudinal strain (GLS) has been developed to detect abnormalities of cardiac contractility in patients with preserved myocardial contractility. However, both tools are not always easy to collect in practice. This is why other ultrasound parameters have been proposed in the literature as a substitute for LVEF and GLS such as the Doppler tissue imaging (DTI)-derived mitral annular systolic peak S-wave velocity (S'), the mitral annular plane systolic excursion (MAPSE) and the longitudinal wall fractional shortening index (LWFS). The purpose of this project is to propose an algorithm using simple parameters (S' wave, lateral MAPSE, septal MAPSE, mean MAPSE and LWFS) to predict LVEF and GLS in order to diagnose patients with impaired systolic function and preserved ejection.

NCT ID: NCT04961658 Recruiting - Septic Shock Clinical Trials

Advanced Mesenchymal Enhanced Cell THerapY for SepTic Patients

AMETHYST
Start date: August 11, 2021
Phase: Phase 1
Study type: Interventional

Bacterial sepsis occurs in patients with severe infections. The condition is caused by toxic substances (toxins) released from bacteria and the patient's elevated inflammatory response to those toxins. In preclinical studies, human mesenchymal stromal cells (MSCs) have been proven to modulate host inflammation in infections, including sepsis. The purpose of this Phase I, open label, dose escalation safety trial is to determine whether escalating doses of enhanced MSCs (GEM00220) are safe and well tolerated in patients with septic shock.

NCT ID: NCT04957316 Not yet recruiting - Severe Septic Shock Clinical Trials

Blood Purification in Patients With Septic Shock

Start date: August 2021
Phase: Phase 4
Study type: Interventional

In recent years, many studies have pointed out that bacterial toxin storm and cytokine storm are the main causes of patients with septic shock and multiple organ dysfunction. Endotoxins are the main mediators of gram-negative bacteria causing systemic inflammation and sepsis. Endotoxins can interact with Toll- Like receptor 4 (TLR4) binding and trigger cytokine storms. The triple-effect blood purification filter has been proven to remove endotoxins, cytokines and urinary toxins, and it has the opportunity to improve shock in patients with sepsis. We hypothesize that blood purification using the three-effect filter can shorten the duration and severity of shock in patients with severe septic shock and reduce the organ damage by removing endotoxin, cytokine and urinary toxins. The primary aim of this study is to investigate the effect of blood purification using the three-effect filter on shortening the duration of septic shock. Other exploratory variables include the reduction of severity of organ damage and other clinical outcomes and prognosis.

NCT ID: NCT04952714 Not yet recruiting - Acute Kidney Injury Clinical Trials

RRT With a Cytokine Absorption Filter (oXiris ®) in Patients With Septic Shock

Start date: September 2021
Phase:
Study type: Observational

Acute kidney injury (AKI) is a common complication in critically ill patients. Multiple studies have reported evidence that the main cause of ARF is sepsis, as part of the Multiple Organ Dysfunction Syndrome: up to 50% of septic patients develop acute renal failure. RRT continues to be the standard management for severe acute renal failure, especially in its continuous modality and applied to the septic patient, generally with hemodynamic instability. The presence of SA-AKI (sepsis-associated acute kidney injury) is associated with short-term and long-term adverse events, which include: prolonged hospital stay, the development of chronic kidney disease (CKD), increased cardiovascular risk and increased risk of death. Its presence is even considered a factor with an independent association with mortality and has a higher fatality rate than ARF developed by another etiology. Different clinical studies have been developed based on the addition of hemoadsorption membranes to RRT that, although they have not shown significant differences in the reduction of mortality, have impacted secondary outcomes such as the reduction of pro-inflammatory cytokines, decrease in vasopressor support requirements, decrease in serum lactate, significant improvement in the SOFA score, improvement in oxygenation indices and decrease in hospital stay. These benefits are presented without reports of adverse events associated with its use. The oXiris® filter was recently developed: a single high permeability membrane capable of removing cytokines and endotoxins during renal support with the addition of antithrombotic properties. The experience of its use is limited to in vitro studies, case reports, retrospective cohorts and an RCT that provide consistent evidence of its benefits. A longitudinal, bi-directional, observational analytical study is proposed. A case-control study nested in a dynamic cohort will be developed to determine the effect of the use of hemofiltration with a cytokine removal filter (oXiris®) on the decrease in mortality at 28 days of patients with acute kidney injury induced by sepsis. (SA-AKI), as well as the dose of vasopressor support, oxygenation parameters and inflammatory markers.