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Shock, Septic clinical trials

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NCT ID: NCT05612529 Terminated - Septic Shock Clinical Trials

Fluid Responseveness in Sepsis and Its Correlation to CVP

Start date: April 1, 2022
Phase:
Study type: Observational

Introduction Aim of the work Patients and methods Type of study Exclusion criteria Statistical analysis Research ethics Reference

NCT ID: NCT05192213 Terminated - Sepsis Clinical Trials

Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock

Start date: August 1, 2021
Phase: Phase 3
Study type: Interventional

A great interest exists regarding substances with an immunomodulatory effect for sepsis patients. Recent data have shown that intravenous vitamin C, together with corticosteroids and thiamine, could prevent progressive organ dysfunction and reduce vasopressor use in patients with severe sepsis and septic shock. Its effect on mortality, on the other hand, is yet to be demonstrated. The Vitamins study aims to conclusively determine, through its prospective, multicentre and double-blinded design including 1090 patients, wether Vitamin C, Thiamine and Hydrocortisone in combination can reduce mortality in patients with septic shock.

NCT ID: NCT04961658 Terminated - 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 the 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: NCT04759989 Terminated - Obesity Clinical Trials

Fluid Resuscitation in Septic Shock Patients With BMI Elevation

FRISSBE
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

To explore the safety and feasibility of alternative fluid resuscitation strategies in obese patients with septic shock.

NCT ID: NCT04434209 Terminated - Sepsis Clinical Trials

A Study Looking at the Use of Biomarkers to Provide Early Indication of Acute Kidney Injury in Patients With Sepsis (Limiting AKI Progression In Sepsis)

LAPIS
Start date: January 19, 2021
Phase: Phase 4
Study type: Interventional

Biomarkers that provide an early indicator of kidney stress could be useful in clinical practice to detect silent episodes of acute kidney injury (AKI) or for early identification of subjects at risk of AKI. Two urinary biomarkers have been identified as early indicators of AKI. The NephroCheck® test is a commercially available test that uses these biomarkers, and this study assesses the use of these in reducing negative clinical outcomes for patients with sepsis-associated AKI. The study will enroll subjects diagnosed with sepsis, including septic shock, who will be randomly assigned to either receive NephroCheck®-guided kidney-sparing and fast-tracking interventions; or to receive current Standard of Care assessment and treatment. NOTE: Participants are no longer being recruited to this study.

NCT ID: NCT04134624 Terminated - Sepsis Clinical Trials

EMS Prehospital Blood Culture Collection and Antibiotic Administration: A Two-Phase Pilot Project to Reduce Mortality in Patients With Severe Sepsis and Septic Shock

Start date: September 11, 2019
Phase: N/A
Study type: Interventional

This study is designed to improve the outcomes for patients suffering from severe sepsis and septic shock (SS/SS) by decreasing the time from first medical contact to antibiotic administration. This is a stepwise study that aims to demonstrate the ability of paramedics to accurately obtain blood cultures prior to hospital arrival, administer a broad spectrum antibiotic and initiate IV fluid resuscitation in patients meeting predefined criteria for SS/SS.

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.

NCT ID: NCT03895853 Terminated - Septic Shock Clinical Trials

Early Metabolic Resuscitation for Septic Shock

Start date: October 4, 2019
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well early metabolic resuscitation therapy works in reducing multi-organ dysfunction in patients with septic shock. Early metabolic resuscitation is made of large doses of glucose, protein, and essential metabolic molecules that may help lower the effects of septic shock on the body. Giving patients early metabolic resuscitation in combination with standard of care may work better in reducing multi-organ dysfunction syndrome in patients with septic shock compared to standard of care alone.

NCT ID: NCT03828929 Terminated - Septic Shock Clinical Trials

Effect of IV Vitamin C, Thiamine, and Steroids on Mortality of Septic Shock

Start date: October 15, 2019
Phase: Phase 3
Study type: Interventional

Preliminary studies show that giving a "cocktail" of intravenous vitamin C, vitamin B1, and steroids to critically ill patients with septic shock may dramatically improve mortality in those patients. These studies suffer from inadequate design due to lack of controls and blinding to prove the causal effect. Our goal is to conduct a prospective blinded randomized control trial to investigate whether this intervention truly effect outcomes.

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.