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Septic Shock clinical trials

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NCT ID: NCT06363149 Recruiting - Septic Shock Clinical Trials

Disseminated Intravascular Coagulation (DIC) Score and Organ Dysfunction in Septic Shock Patients

Start date: April 12, 2024
Phase:
Study type: Observational

Septic shock is common complication in patients with critical illnesses, with higher incidence in low and medium income countries like ours. Disseminated intravascular coagulation (DIC) is also common in patients presenting to intensive care units. Further DIC is common coexisting condition seen in many patients presenting with sepsis and septic shock. Both DIC and septic shock individually are associated with very high mortality and morbidity and coexistence of both increase risk manifold. Organ dysfunction is a complication of both septic shock and DIC individually and in presence of coexistence risk further multiply. DIC scoring of every patient at risk as in patients presenting with septic shock help us to predict about patients having more chances to convert to overt DIC. Understanding effects of DIC on organ dysfunction in septic shock patients can help to prognosticate and guide towards early intervention. Also, there is paucity of literature on effect of DIC score changes on organ dysfunction in patients with septic shock.

NCT ID: NCT06287684 Recruiting - Sepsis Clinical Trials

Molecular Endotype-Specific Dynamics of Lung Endothelial Barrier Integrity in Sepsis

MENDSEP
Start date: September 13, 2023
Phase:
Study type: Observational [Patient Registry]

Sepsis is a complex syndrome that causes lethal organ dysfunction due to an abnormal host response to infection. No drug specifically targeting sepsis has been approved. The heterogeneity in sepsis pathophysiology hinders the identification of patients who would benefit, or be harmed, from specific therapeutic interventions. Recent clinical genomics studies have shown that sepsis patients can be stratified as molecular endotypes, or subclasses, with important clinical implications. Classifying sepsis patients as molecular endotypes revealed that a poor prognosis endotype was characterized by immunosuppression and septic shock. Against this backdrop, the study hypothesis is that a poor prognosis for sepsis is defined by a molecular endotype reflecting impaired innate immune and endothelial barrier integrity in the primary anatomical site of infection.

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: NCT06181604 Recruiting - Sepsis Clinical Trials

Multicenter Symphony IL-6 Monitoring Sepsis ICU Study

SYMON
Start date: January 12, 2024
Phase:
Study type: Observational

The primary objective of this study is to establish an IL-6 concentration cutoff and optimal time point(s) for using Symphony IL-6 that predict 28-day mortality in patients who are admitted or are intended to be admitted to the intensive care unit (ICU) diagnosed with sepsis or septic shock.

NCT ID: NCT06178822 Recruiting - Sepsis Clinical Trials

Towards Novel BIOmarkers to Diagnose SEPsis on the Emergency Room

BIOSEP
Start date: October 25, 2022
Phase:
Study type: Observational [Patient Registry]

Objectives: 1. To compare the immune response of patients with or without sepsis presenting to the ED with a(n) (suspected) infection. 2. To determine immune response aberrations that are associated with an increased risk of developing sepsis in patients presenting to the ED with a(n) (suspected) infection without sepsis. 3. To determine the long term cognitive and physical sequelae of sepsis after admission.

NCT ID: NCT06145828 Recruiting - Septic Shock Clinical Trials

Clinical Application of Cytokine Adsorption Technique in AIDS Patients With Severe Pneumonia and/or Septic Shock

Start date: October 23, 2023
Phase:
Study type: Observational

Observing the Real-World Application Effectiveness of Cytokine Immune Adsorption Technology in AIDS Patients with Severe Pneumonia or septic shock.

NCT ID: NCT06140147 Recruiting - Septic Shock Clinical Trials

Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients

REDUSE
Start date: November 27, 2023
Phase: N/A
Study type: Interventional

The objective of this trial is to assess the beneficial and harmful effects of a restrictive strategy for administration of non-resuscitation fluids in adult patients with septic shock.

NCT ID: NCT06122909 Recruiting - Septic Shock Clinical Trials

The Effect Of Resuscitation Guided By Two Different Dynamic Parameters On Time To Normalization Of The Capillary Refill Time In Adult Patients With Septic Shock

Start date: July 21, 2023
Phase: Phase 3
Study type: Interventional

The aim of this study is to compare the effect of resuscitation guided by Left ventricular outflow tract-velocity time integral (LVOT-VTI) variation versus the effect of resuscitation guided by inferior vena cava (IVC) variation on time to normalization of the capillary refill time in adult patients with septic shock, amount of resuscitation fluids, rate of vasopressor and ICU length of stay.

NCT ID: NCT06119815 Recruiting - Septic Shock Clinical Trials

CO2 Gap Changes Versus Inferior Vena Cava Collapsibility in Relation to Cardiac Index as a Prognostic Value in Septic Shock

Start date: October 10, 2023
Phase: N/A
Study type: Interventional

In 2016, sepsis and septic shock was redocumented as fatal organ dysfunction caused by infection-induced host response disorders (Singer et al. 2016). Infectious shock is a subtype of sepsis; its circulation abnormalities significantly increase the mortality rate. The definition was updated to facilitate rapid identification and timely treatment. Despite the continuous progress of awareness and intervention, the mortality rate of septic shock is approaching 40% or more (Gasim et al. 2016, Karampela et al. 2022). Infectious shock exists in the presence of imbalance of oxygen supply and demand as well as tissue hypoxia, early improvement of tissue hypoperfusion is key to the treatment, a specific cluster treatment program was recommended in the guidelines of sepsis rescue action (Rhodes et al. 2017). Severe sepsis remains associated with high mortality, and the early recognition of the signs of tissue hypoperfusion is crucial in its management. The effectiveness of oxygen-derived parameters as resuscitation goals has been questioned, and the latest data have failed to demonstrate clinical advantage (Rudd et al. 2020). Prompt diagnosis and appropriate treatment of sepsis are of ulmost importance and key to survival. However, routinely used biomarkers, such as C-reactive protein and procalcitonin, have shown moderate diagnostic and prognostic value. Of note, the recent consensus definition for sepsis is based on clinical criteria, implying the paucity of reliable sepsis biomarkers. The new diagnostic criteria also incorporate the use of the SOFA score, a composite prediction tool, which is derived by a combination of clinical signs and biomarkers of organ dysfunction, leaving aside classic inflammatory biomarkers (Pierrakos et al. 2020, Karampela et al. 2022). The venous oxygen saturation (SvO2) is <70% in the majority of patients with severe sepsis on admission to the intensive care unit (ICU). The central venous-to-arterial carbon dioxide difference or only carbon dioxide gap (PCO2 gap) has gained relevance as a measure of assessment of several parameters (Mallat et al. 2015). The balance of dioxide carbon (CO2) production by the tissues and its elimination through the lungs can be reflected by the difference between the mixed venous content (CvCO2) and the arterial content (CaCO2). This venous-arterial difference in CO2 content (CCO2) can be estimated by the following equation: ΔPCO2 = PvCO2 - PaCO2, denominated PCO2 gap and in physiological conditions it ranges from 2 to 5 mmHg. In a few words, it indicates the difference between partial pressure of carbon dioxide in central venous blood (PvCO2) and arterial blood (PaCO2) (Janotka et al. 2021). The venous-to-arterial carbon dioxide difference (Pv-aCO2) can indicate the adequacy of microvascular blood flow in the early phases of resuscitation in sepsis (Ospina-Tascon et al. 2016, de Sá 2022). Hence, other resuscitation goals, such as PCO2 gap, have been suggested, due to their ability to predict adverse clinical outcomes and simplicity in patients achieving normal oxygen derived parameters during the early phases of resuscitation in septic shock. The PCO2 gap can be a marker of cardiac output adequacy in global metabolic conditions that are less affected by the impairment of oxygen extraction capacity (Bitar et al. 2020).