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Shock, Septic clinical trials

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NCT ID: NCT06306001 Not yet recruiting - Neonatal Sepsis Clinical Trials

Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock

Start date: March 15, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Preterm infants (born at less than 37 weeks of pregnancy) sometimes develop a serious blood infection leading to low blood pressure, which does not respond to saline or to the standard medicines for increasing blood pressure, such as dopamine and epinephrine. The goal of this research study is to compare the effect of giving an injectable medicine called Methylene blue (MB) versus not giving MB to such preterm infants who are unresponsive to standard treatment. The main questions that this study aims to answer is: 1. Whether MB treatment reduces death to any cause as compared to no MB treatment. 2. Whether treatment with MB reduces the time to achieve normal blood pressure 3. Whether treatment with MB reduces the time to stoppage of all blood pressure medications, steroids and normal saline. 4. Whether treatment with MB improves heart function as measured by echocardiography at 24 and 48 hours.

NCT ID: NCT06302998 Not yet recruiting - Sepsis Clinical Trials

Dexmedetomidine and Vasopressin in Septic Shock

DecatSepsis-2
Start date: June 2024
Phase: Phase 2
Study type: Interventional

Rudiger and Singer suggested strategies for refining adrenergic stress (decatecholaminization). They proposed the use of dexmedetomidine and vasopressin to reduce the catecholamine load during sepsis. The investigators will use vasopressin as the primary vasopressor and a heart rate-calibrated dexmedetomidine infusion in septic shock patients. The investigators of the current study will use DEXPRESSIN in septic shock patients to investigate the effects of decatecholaminization on in-hospital mortality.

NCT ID: NCT06294730 Recruiting - Sepsis Clinical Trials

COronary Microcirculation and Troponin Elevation in Septic Shock

COMTESS
Start date: June 13, 2019
Phase:
Study type: Observational

Plasma cardiac troponin (cTn) elevation is an indicator of increased mortality in patients with sepsis yet the underlying cause of troponin elevation in sepsis is not known. The COMTESS study investigates whether elevated high-sensitive cardiac Troponin T (hs-cTnT) levels in hemodynamically unstable patients with sepsis can be explained by an underlying coronary artery disease or a process within the coronary microcirculation. Fifty patients with sepsis and with hs-cTnT elevation (>15 ng/L) will undergo coronary angiography, including an assessment of coronary flow using a method called thermo-dilution to record the index of microcirculatory resistance (IMR) in the left anterior descending artery (LAD). The relationship between IMR and hs-cTnT will subsequently be analysed. It is important to identify the underlying causes of elevated cTn during sepsis to target further research with an aim to improve the survival in patients suffering from this condition.

NCT ID: NCT06258291 Not yet recruiting - Septic Shock Clinical Trials

First in Human Trial to Assess the Safety & Efficacy of HemoSystem REBOOT in Patients With Sepsis-induced Immunosuppression

(RESTORE)
Start date: September 15, 2024
Phase: N/A
Study type: Interventional

The aim of this randomized controlled trial is to restore immune function by selectively removing three mediators largely contributing to sepsis-induced immunosuppression from extracorporeal circulation.

NCT ID: NCT06242626 Completed - Septic Shock Clinical Trials

Euthyroid Sick Syndrome in Septic Shock

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

This prospective observational cohort study included all septic shock patients with two groups of ESS and anylised in 28-day outcome, clinical biochemical parameters and hemodynamic monitoring.

NCT ID: NCT06234592 Not yet recruiting - Acute Kidney Injury Clinical Trials

The Effect of Vasopressor Therapy on Renal Perfusion in Septic Shock

REPERFUSE
Start date: January 2024
Phase: N/A
Study type: Interventional

Acute kidney injury (AKI) is a common complication of septic shock and together these conditions carry a high mortality risk. In septic patients who develop severe AKI renal cortical perfusion is deficient despite normal macrovascular organ blood flow. This intra-renal perfusion abnormality may be amenable to pharmacological manipulation, which may offer mechanistic insight into the pathophysiology of septic AKI. The aim of the current study is to investigate the effects of vasopressin and angiotensin II on renal microcirculatory perfusion in a cohort of patients with septic shock.

NCT ID: NCT06227702 Not yet recruiting - Septic Shock Clinical Trials

Vexus-guided Fluid Management in Patients With Septic Shock After the Resuscitation Phase

VEXUS
Start date: February 1, 2024
Phase: N/A
Study type: Interventional

It is well recognized the association between fluid volume administered and positive fluid balance with adverse outcomes . Active fluid removal is widely practiced in an attempt to mitigate this potential damage. However, it is not clear which is the best approach for the post-resuscitation phase in critically ill patients. In this context, Point-of-Care ultrasound (POCUS) through Venous Excess Ultrasound (VExUS) would allow the assessment of the degree of venous congestion, through the visualization of vascular anatomy and blood velocity using Doppler, being potentially useful to guide fluid removal. The investigators will evaluate whether fluid management after the initial phase of VExUS-guided resuscitation is able to improve outcomes compared to usual therapy in patients with septic shock. This is a single center, prospective, open and randomized clinical study in which patients admitted to intensive care will be included after the first 24 hours of resuscitation. A total of 200 patients will be randomized either to volume management guided by VExUS or to the standard therapy arm as per usual practice.

NCT ID: NCT06226441 Recruiting - Sepsis Clinical Trials

Aminoglycoside Administration in Septic Patients

AMASEP
Start date: June 2, 2023
Phase: N/A
Study type: Interventional

Sepsis is one of the main causes of mortality and morbidity in an ICU setting, while the responsible microorganisms most frequently isolated are multidrug-resistant gram-negative bacteria. Aminoglycoseides (AG) seem to be particularly effective in dealing with these microbes, however their potential toxicity, especially nephrotoxicity, often makes them an unsuitable treatment option. This becomes particularly evident in patients with already impaired renal function, a common occurrence in septic patients requiring ICU treatment. AG are bacteriocidal antibiotics the efficiency of which depends on the maximum concentration in patients' serum (Cpeak). Pathophysiological changes in critically ill patients, result in significant distribution of the drug extravascullary resulting in a decreased concentration of the biologically active component. On the other hand, impaired renal clearance results in high serum drug levels (C trough) making the desired once-daily administration not always achieved. The purpose of this study is to test the hypothesis of successful clearance of AG after achieving satisfactory serum levels and therefore their maximum effect minimizing potential toxicity, by using continuous veno-venous haemodiafiltration in patients with sepsis or septic shock and impaired renal function. This way, the aforementioned antibiotics could become a more frequent and potentially earlier choice for physicians in the treatment of sepsis and septic shock patients from multidrug-resistant microbes.

NCT ID: NCT06225258 Recruiting - Pneumonia Clinical Trials

Xanthohumol as an Adjuvant in the Treatment of Septic Shock

Start date: May 9, 2023
Phase: Phase 2
Study type: Interventional

Septic shock (SS) is a life-threatening condition resulting from excessive inflammatory response to bacterial, viral or/and fungal infections. It is associated with dysregulation of the immune system, activation of immune cells, and massive release of cytokines, commonly known as the cytokine storm (CS). The clinical manifestations of SS depend on the initial site of infection. However, the classic symptoms are associated with severe dysfunction of the respiratory and cardiovascular systems, which are observed from the early phase. Respiratory insufficiency frequently requires different forms of oxygen supplementation, including mechanical ventilation and even extracorporeal oxygenation. The severity of respiratory and other organ dysfunction depends on the inflammatory response to the infection and circulating toxins, which correspond to excessive cytokine release. In the past years, several studies documented that reduction of SS-related inflammatory response and CS improved organ function and alleviated the clinical course of SS. Unfortunately, an effective strong anti-inflammatory without side effects medications has not yet been found. Therefore, the use of natural anti-inflammatory and antioxidant substances seems very promising. Xanthohumol (Xn) is a natural prenylated chalcone extracted from the female inflorescences of hop cones (Humulus lupus) and possesses strong anti-inflammatory and antioxidant properties. It is widely used as a supplement to diet. Xanthohumol inhibits CS and has been showed to be an effective medication for reducing the severity of lung injury. It has been documented that Xn inhibits proinflammatory pathways in a different manner. A decrease in cytokine production and release can affect endothelial function and correct inflammatory-related vascular hyperpermeability, reducing uncontrolled water shift to extravascular space and then tissue edema. Clinical observation showed that administration of Xn alleviated clinical course, improved respiratory function, and reduced mortality in critically ill COVID-19 patients. Xanthohumol is safe and well tolerated by humans, and no adverse effects have been reported yet. Based on its strong anti-inflammatory and antioxidative properties, it can be speculated that the use of Xn can effectively reduce the inflammatory response and improve the clinical course in SS patients.

NCT ID: NCT06224881 Completed - Septic Shock Clinical Trials

Vitamin C Deficiency in Septic Shock

Start date: December 1, 2021
Phase: Phase 4
Study type: Interventional

Objectives: investigators aim to study the effect of addition of vitamin C as a part of treatment in septic shock patients on: Hemodynamics, Inflammation status and ICU outcome. Subjects and methods: A prospective interventional randomized cohort study, was conducted on 150 consecutive patients who were admitted to the ICU with septic shock based on SIRS, SOFA and APACHE II. Treatment group (n=75) had given ascorbic acid (Vitamin C) parenterally 6gm daily and control group (n=75). Measuring the level of Vitamin C in all study population (normal range 50-70 μM/L) before and after period of 4 days.