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Shock, Septic clinical trials

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NCT ID: NCT05578534 Completed - Septic Shock Clinical Trials

CO2 Gap Changes in Septic Shock in Relation to Cardiac Output

Start date: December 1, 2020
Phase:
Study type: Observational [Patient Registry]

Background The arteriovenous difference of partial pressure of carbon dioxide (PCO2) between mixed or central venous blood and arterial blood is the ∆PCO2 or CO2 gap. Previous data demonstrated a strong relationship between ∆PCO2 and cardiac index (CI) at the very early phase of resuscitation in septic shock. Monitoring the ∆PCO2 from the beginning of the resuscitation may be a useful tool to assess the adequacy of cardiac output (CO) in tissue perfusion. Aim of work: To examine behavior of ∆PCO2 during early management of septic shock. Methodology: Seventy-six patients with diagnosis of septic shock admitted to critical care department, Cairo university hospitals. We classified the study population according to initial resuscitation response, initial CO2 gap, or 28-days mortality. The response vs non-response to initial resuscitation, ICU morbidity and recovery rate were the study primary outcomes while secondary outcomes included ICU length of stay (LOS) and 28-day ICU Mortality.

NCT ID: NCT05401695 Completed - Septic Shock Clinical Trials

The Role of Blood Purification by Hemoadsorption as Adjunctive Treatment in Children With Septic Shock

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

Sepsis is a major healthcare problem and leading cause of death in the pediatric population. Despite advances in supportive care of critically ill patients, sepsis remains an important cause of death worldwide in children. Overall, sepsis incidence peaked in early childhood. There were an estimated 20.3 million incident sepsis cases worldwide among children younger than 5 years. The Surviving Sepsis Campaign (SSC), which standardized the evidence-base approach to management of septic shock and other sepsis-associated organ dysfunction in children, was recently updated. Nevertheless, mortality and costs are still high. Sepsis is characterized by a complex systemic inflammatory response to a microbial pathogen. A dysregulated host response to infection may result in life-threatening multi-organ dysfunction. Endotoxin, which is found in the outer membrane of Gram-negative bacteria, plays an important role in the pathogenesis of septic shock by producing proinflammatory cytokines. High levels of endotoxin and proinflammatory cytokines are associated with a high mortality rate. Treatment strategies in sepsis and septic shock include early and adequate fluid resuscitation, vasopressors and inotropic support when indicated, early use of broad-spectrum antibiotics with source control, with close monitoring and organ support, if indicated. Other therapies such as immune-modulation and blood purification have been tried to improve outcomes in patients with sepsis and septic shock. Immunomodulation and blood purification techniques aim at restoring the balance of the immune response to infection, by removing the triggers for the response and the cytokines produced and thereby achieve immune homeostasis. Removing endotoxin and inflammatory cytokines would be an effective adjunctive approach in the management of severe sepsis. Direct hemoadsorption (HA) is an extracorporeal technique utilized for blood purification. It involves the passage of blood through an adsorption cartridge, where solutes are removed by direct binding to the sorbent material. Over the years, new adsorption cartridge, with improved characteristics have been developed. Resin-directed hemoadsorption is associated with improved oxygenation, hemodynamic status and cardiac function. However, most studies include only adults, and little information is available regarding the clinical experience and efficacy of blood purification for pediatric septic shock. This pilot study aimed to evaluate the overall clinical outcomes among children who received direct hemoadsorption as an adjunctive treatment for refractory septic shock with high severity scores, compared with outcomes among children admitted to the PICU who received standard treatment.

NCT ID: NCT05358912 Completed - Septic Shock Clinical Trials

Efficacy of Targeted Abdominal Perfusion Pressure in Septic Shock

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

Septic shock is a clinical condition that is defined as a subset of sepsis that causes very high mortality and morbidity. Surviving sepsis campaign guideline states that the target mean arterial pressure should be 65 mmHg and above in septic shock patients. It is known that abdominal pressure increases and perfusion of intra-abdominal organs decreases in septic shock patients. With this study, we aim to investigate the effects of targeted abdominal perfusion pressure (60 mmHg and above) on renal injury, reversal of renal injury, liver functions and ultimately mortality in patients with septic shock.

NCT ID: NCT05283317 Completed - Sepsis Clinical Trials

Effect of Mesenchymal Stromal Cells on Sepsis and Septic Shock

Start date: March 11, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Methods:Ten patients were enrolled in the study. Adipose derived-MSCs infusions were given (1x 106/ kg, on 1st, 3rd, 5th, 7th and 9th days of therapy) together with Standard therapy. Before the MSCs applications, blood samples were collected for cytokine assessment (TNF-α, IFN-γ, IL-2, IL-4, IL-6, IL-10). The clinical and laboratory improvements were recorded and compared with control groups selected retrospectively.

NCT ID: NCT05283083 Completed - Sepsis Clinical Trials

Decatecholaminisation of Septic Shock With Dexmedetomidine and In-hospital Mortality

DECATSepsis
Start date: March 25, 2022
Phase: Phase 2
Study type: Interventional

The study aims to determine whether the infusion of DEX in septic shock can reduce in-hospital mortality, norepinephrine infusion, need and duration for mechanical ventilation, and acute kidney injury without significant adverse events.

NCT ID: NCT05271032 Completed - Septic Shock Clinical Trials

PiCCO ASSESSMENT IN PATIENTS WITH SEPTIC SHOCK

Start date: March 1, 2018
Phase:
Study type: Observational

Sepsis is the result of a complex pathological process which involves an intravascular inflammatory state, loss of vascular tone, endothelial injury, extravascular leakage, and often inefficient myocardial contractility. These affect the cardiovascular homeostasis as well as the regional perfusion and tissue oxygenation of patient. The importance of early cardiovascular support in septic patients is the reason why, for about fifteen years, the implementation of standardized resuscitation protocols has been emphasized. The Surviving Sepsis Campaign Guidelines (SSG) recommend an initial fluid resuscitation followed by use of a vasoactive agent such as norepinephrine for the treatment of patients with septic shock. To understand the impact of the hemodynamic support provided by the resuscitation strategy, the assessment of surrogate clinical parameters is pivotal. According to the current guidelines, the increase of mean arterial pressure (MAP) above 65 mmHg represents the threshold in defining patients as "stable". Although this strategy has been well established, its impact on the actual hemodynamic profile of the septic patient, remains a subject of ongoing controversy. In this scenario, the transpulmonary thermodilution technique (TPTD) allows invasive assessment of the patient hemodynamic profile in terms of fluid responsiveness, vasomotor status, or global cardiac efficiency. By using this technique, several studies highlighted a wide variability in the individual response of patients undergoing cardiovascular stabilization guided by SSG. This suggests that the implementation of a "customized" resuscitation protocol based TPTD derived parameters rather than resuscitation strategy guided by a fixed mathematic model, could be preferred. However, in daily clinical practice, the use of this advanced hemodynamic monitoring system in not routinely used, though it is often reserved in case of failure of the initial SSG-resuscitation protocol. The investigators supposed that, even if the initial resuscitative efforts were successful in achieving the SSG targets i.e. by restoring the MAP > 65 mmHg, this could still be inadequate in some patients. Accordingly, the investigators hereby will report the hemodynamic profile of patients with septic shock admitted in ICU.

NCT ID: NCT05270798 Completed - Septic Shock Clinical Trials

Thyroid Hormone Supplementation in Patients With Septic Shock

Start date: May 1, 2022
Phase: Phase 2
Study type: Interventional

The primary aim of the study would be to determine whether there is a difference in survival in the Intensive Care Unit between the group of patients with septic shock diagnosed with euthyroid sick syndrome who were treated with T3 hormone compared to the group of patients not treated with this hormone. Secondary objectives of the research would be: Compare the level of thyroid hormones between the examined groups and 1. laboratory indicators of septic shock (C-reactive protein-CRP, procalcitonin, leukocytes, acid-base status, lactates) 2. APACHE II, SOFA and SAPS II patient assessment scales, 3. inflammatory prognostic systems (ratio of CRP and albumin-modified Glasgow prognostic score-mGPS, ratio of neutrophils and lymphocytes - NLR, ratio of platelets and lymphocytes - PLR, and ratio of leukocytes and CRP, prognostic index - PI) 4. hemodynamic stability of patients (MAP, systolic and diastolic pressure) in the periods of admission T0, T3, T6, T12, T24 and every 24 hours for 4 days, 5. effect of vasoactive drugs, 6. the need for mechanical ventilation categorized as yes or no, in case - number of respirator days, 7. length of stay in the Intensive Care Unit, 8. treatment outcome categorized as 28 day survival.

NCT ID: NCT05249088 Completed - Shock, Septic Clinical Trials

Protocolized Reduction of Non-resuscitation Fluids vs Usual Care in Septic Shock Feasibility Trial

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

The objectives of this feasibility trial are to assess the efficacy and feasibility of methods and procedures of a protocol purposed to compare a reduction of administration of non-resuscitation fluids to usual care in patients with septic shock.

NCT ID: NCT05208112 Completed - Sepsis Clinical Trials

Intravenously Administered M6229 in Critically Ill Sepsis Patients

HistoSeps
Start date: April 5, 2022
Phase: Phase 1
Study type: Interventional

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Mortality is high and survivors frequently suffer from long-term sequelae. Extracellular histones have been identified as essential mediators in the pathogenesis of sepsis and septic shock. These toxic molecules are released by damaged cells in response to infection and high extracellular levels can induce tissue injury and multiple organ dysfunction syndrome. Extracellular histones can be neutralized by complexation with the new candidate drug called M6229, a non-anticoagulant heparin, allowing the use of elevated dose levels relative to regular unfractionated heparin. This project aims at the roll-out of a first-in-man clinical study in sepsis patients evaluating the safety, tolerability, pharmacokinetics and pharmacodynamic effects of intravenously administered M6229 in subjects suffering from sepsis.

NCT ID: NCT05172479 Completed - Sepsis Clinical Trials

Prognostic Accuracy of qSOFA, SIRS, and EWSs for In-hospital Mortality in Emergency Department

PASSEM
Start date: December 12, 2021
Phase:
Study type: Observational

Early identification of a patient with infection who may develop sepsis is of utmost importance. Unfortunately, this remains elusive because no single clinical measure or test can reflect complex pathophysiological changes in patients with sepsis. However, multiple clinical and laboratory parameters indicate impending sepsis and organ dysfunction. Screening tools using these parameters can help identify the condition, such as SIRS, quick SOFA (qSOFA), National Early Warning Score (NEWS), or Modified Early Warning Score (MEWS). The 2016 SCCM/ESICM task force recommended using qSOFA, while the 2021 Surviving Sepsis Campaign strongly recommended against its use compared with SIRS, NEWS, or MEWS as a single screening tool for sepsis or septic shock. We hypothesised that qSOFA has greater prognostic accuracy than SIRS and EWS (NEWS/NEWS2/MEWS).