Clinical Trials Logo

Septic Shock clinical trials

View clinical trials related to Septic Shock.

Filter by:

NCT ID: NCT04516395 Not yet recruiting - Sepsis Clinical Trials

Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae

Start date: September 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the treatment outcomes in patients with CRE infections.

NCT ID: NCT04515511 Recruiting - Septic Shock Clinical Trials

Whether a Minimal Volume Could Predict Fluid Responsiveness Using Thermodilution by PAC in Septic Shock Patients

Start date: July 1, 2019
Phase: N/A
Study type: Interventional

Assessment of fluid responsiveness (FR) is to detect whether patient could benefit from fluid therapy. Mini fluid challenge has been widely used in clinical practice to prevent patients from volume overload. In clinical practice, 100 mL or 250 mL have been used most frequently and FR was defined as an increase in CO greater than 10% as much as the changes in CO after infusion of 500 mL. While using a half of volume infusion and assessed by the traditional standard of FR, this might misclassify more patients as nonresponders. In that it is imperative to test the predictive ability of mini fluid and find out the threshold of cutoff value. Meanwhile, in almost mini-FC, cardiac output were measured by echocardiography(VTi) and pulse contour,None of the studies conducted cardiac output (CO)measurement by gold standard method of thermodilution by pulmonary artery catheter (PAC). The correlation between new generated CO measurements and PAC varies in different studies as well. It is imperative to investigate the reliability of mini-FC to predicting fluid responsiveness(FR).The investigator's study is to detect the predictive minimal volume using thermodilution by PAC in septic shock patient.

NCT ID: NCT04513288 Recruiting - Sepsis Clinical Trials

ICITRU : Randomized Trial of Immunonutrition With L-citrulline in Patients Hospitalized in Intensive Care for Sepsis or Septic Shock

ICITRU
Start date: May 20, 2022
Phase: N/A
Study type: Interventional

Immunonutrition in intensive care has not yet demonstrated a beneficial effect on organ failure, the acquisition of nosocomial infections, or mortality. It did not correct for acquired immunosuppression in intensive care patients. Despite numerous methodological problems (use of several pharmaconutrients, very heterogeneous set of patients) and the absence of clinical data, deleterious effects have been attributed to immunonutrition in intensive care, in particular in septic patients and patients in intensive care . Arginine (ARG) is a semi-essential amino acid involved in many immunological mechanisms. It is synthesized in sufficient quantity under normal conditions but quickly becomes insufficient under catabolic conditions such as in severe sepsis. Arginine is not only the precursor of nitrogen monoxide (NO) but also an essential substrate for numerous enzymatic reactions which participate in the maintenance of immune homeostasis, in particular T lymphocyte function. Depletion of the cellular medium in arginine will induce an abnormality in the metabolism of immune cells responsible for a dysfunction of these cells (lymphopenia linked to early apoptosis) and thus expose patients to organ failure and nosocomial infections. It has been found that hypoargininemia in intensive care patients is associated with the persistence of organ dysfunction (SOFA score), the occurrence of nosocomial infections and mortality. Also, it has been demonstrated that in these patients, enteral administration of ARG was not deleterious and increased ornithine synthesis, suggesting a preferential use of ARG via the arginases route, without significant increase in argininaemia or effect on immune functions. L-citrulline (CIT), an endogenous precursor of ARG, constitutes an interesting alternative for increasing the availability of ARG. Sponsor recent data demonstrate that the administration of CIT in intensive care is not deleterious and that it very significantly reduces mortality in an animal model of sepsis, corrects hypoargininemia, with convincing data on immunological parameters such as lymphopenia, which is associated with mortality, organ dysfunction and the occurrence of nosocomial infections. The availability of ARG directly impacts the mitochondrial metabolism of T lymphocytes and their function. Our hypothesis is therefore that CIT supplementation is more effective than administration of ARG in correcting hypoargininemia, reducing lymphocyte dysfunction, correcting immunosuppression and organ dysfunction in septic patients admitted to intensive care.

NCT ID: NCT04508946 Completed - Sepsis Clinical Trials

Triple Therapy in Septic Shock Patients

Start date: August 1, 2019
Phase: Phase 3
Study type: Interventional

this study is conducted to evaluate the role of the novel triple therapy combination in reducing the mortality rate, reducing the shock time, and reversal of organ damage. the study includes two arms, the first arm is the control which received hydrocortisone monotherapy and the second arm is the intervention arm which received the triple therapy regimen. calculation of 28 days in-hospital mortality is the primary outcome. shock time, vasopressor doses, infection markers, and organ function tests are the secondary outcomes. the data will be analyzed by student t-test or Mann Whitney test, Fischer exact or chi-square test for numbers, repeated measures ANOVA will be used to consider confounders and other parameters, mortality will be expressed by Kaplan Meier and ROC curve. For Multivariate analysis of repeated quantitative outcomes, linear mixed models were used to quantify the relationship between one dependent variable (SOFA, SCr, doses of vasopressors) and many independent variables including group type and sepsis phenotype adjusted to other clinical and demographic factors.

NCT ID: NCT04494789 Completed - Septic Shock Clinical Trials

Fludrocortisone Dose Response Relationship in Septic Shock - FluDReSS

FluDReSS
Start date: February 11, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the most suitable dose of Fludrocortisone in reversal of sepsis and shock associated with sepsis in patients who are admitted to the ICU. The investigators will be looking to see whether patients receiving Fludrocortisone at different doses recover quicker and spend less time in hospital and in ICU, and to understand the reasons why this happens at certain doses. Sepsis is caused by toxic substances (toxins) from bacteria and other organism entering the bloodstream from a site of infection. In some people, the infection can progress to sepsis and septic shock where the functions of organs in the body are affected. Patients suffering from sepsis and septic shock are commonly managed in the intensive care unit (ICU) where they are prescribed antibiotics as standard therapy, as well as other therapies to support the functions of the body. Fludrocortisone is a steroid that has previously shown to be beneficial to help in shock in patients in ICU, but more information is required about the exact dose that is required to achieve this. This has been shown by previous research. However, the exact role of Fludrocortisone and the best dose has not been studied adequately to date as well as the ways in how it works within the body. The study aims to look tat the dose and the way it works.

NCT ID: NCT04494074 Recruiting - Septic Shock Clinical Trials

Fever Control Using External Cooling in Mechanically Ventilated Patients With Septic Shock

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

The best strategy for managing fever in patients with septic shock remains unknown. In a pilot study, the investigators showed that fever control at normothermia allowed a better control of shock and evolution of organ failures. In this second trial the investigators will conduct a multicentre, open-label, randomized controlled, superiority trial in which two strategies will be compared: 1. Respect of fever 2. Fever control at normothermia using external cooling The primary end point will be d-60 mortality.

NCT ID: NCT04492280 Completed - Septic Shock Clinical Trials

Evaluation of the Role of Hydrocortisone Either Alone or Combined With Fludrocortisone in the Outcome of Septic Shock in Adults

Start date: September 1, 2018
Phase: Phase 4
Study type: Interventional

During Infection, oflfending microbes interact with the host immune system producing a downstream inflammatory cascade involving cytokines and other mediators, which in turn triggers a systemic response. The resultant effects linclude vasodilation, increased vascular permeability, myocardial depression, and impairment of the coagulation cascade, resulting in global imbalance of systemic oxygen supply and demand. During the late stage of sepsis, immunosuppression predominates, leading to multi-organ dysfunction and further clinical deterioration . Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection with two or three on Quick Sepsis-related organ failure assessment score (qSOFA). Septic shock is defined as the presence of sepsis and refractory hypotension to fluid management. Vasopressors are needed to maintain systolic blood pressure more than 90mmHg or mean blood pressure more than 65 mmHg . Experimental and Clinical evidence suggests that sepsis is associated with dysregulated response of Hypothalamic-pituitary-adrenal axis that may involve any of the steps from cortisol production to cortisol use by cells . Glucocorticoid therapy for the treatment of septic shock remains controversial, with conflicting evidence regarding a mortality benefit. It has been used in patients with septic shock who remained hypotensive after fluid and vasopressor resuscitation. Fludrocortisone is a corticosteroid and acts as a powerful mineralocorticoid along with some additional but comparatively very weak glucocorticoid activity. Relative to cortisol, it is to 10 times the glucocorticoid potency but 250 to 800 times the mineralocorticoid potency . Fludrocortisone is added to hydrocortisone to provide additional mineralocorticoid potency. The rationale for adding mineralocorticoid treatment is that an experimental sepsis study showed marked nuclear factor NF-κB mediated down regulation of vascular mineralocorticoid receptors . Corticosteroids attenuate inflammation in various organs an effect partly related to inhibition of nuclear factor NF-κB. Improve cardiovascular function by restoring effective blood volume through increased mineralocorticoid activity and by increasing systemic vascular resistance through vascular α-Adrenergic responsiveness and reduces inflammation-mediated vasodilation .

NCT ID: NCT04474431 Recruiting - Septic Shock Clinical Trials

Correlation of VEGF-A and Fluid Balance in Septic Shock

VEGFluid
Start date: December 24, 2019
Phase: N/A
Study type: Interventional

VEGF is a key molecule in the control of vascular permeability via interactions with the VEGF-receptor on the endothelial cell. Several authors reported plasma VEGF levels are elevated in sepsis shock and associated with increased mortality (1,2). In septic shock, the main elements of treatment are intravenous fluids, appropriate antibiotics and vasopressors. Some authors observed positive fluid balance is associated with increased mortality rates in patients (3,4). To the best of our knowledge, no studies have shown a correlation between VEGF levels and the fluid balance. The aim of our study was to determine the role of VEGF in capillary leakage and the positive fluid balance in septic shock.

NCT ID: NCT04470973 Recruiting - Sepsis Clinical Trials

Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Patients.

PHARAOH
Start date: July 15, 2020
Phase:
Study type: Observational

Infections in critically ill patients are a major healthcare problem and an important source of morbidity and mortality. Since critically ill patients often have altered pharmacokinetics (PK) compared to non-critically ill patients there is a substantial risk that present standard dosing regimens of antibiotics lead to suboptimal outcomes for patients on the ICU or the ED. To prevent the risk of inadequate dosing in ICU patients, it is important to fully understand the PK of antibiotics in this vulnerable group in order to optimize the dosing regimens. With this study, the investigators will describe the pharmacokinetics of cefuroxime and amikacin in ICU and ED patients. A heterogeneous population of ICU and ED patients will be included to be able to find which factors might influence the pharmacokinetics of these drugs and to what extent. By using population modeling the investigators will simulate different dosing regimens and MIC values and compare probability of target attainment between each of these dose and MIC combinations. This will allow the investigators to optimize dosing regimens of cefuroxime and amikacin in critically ill patients.

NCT ID: NCT04470856 Completed - Septic Shock Clinical Trials

Carotid Doppler and EEOT for Fluid Responsiveness Prediction

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Fluid responsiveness prediction prior to fluid challenge administration is a topic of interest, which has been extensively investigated, but remains challenging. In clinical practice, functional hemodynamic tests (FHT) consisting of maneuvers that affect cardiac function and/or heart-lung interaction, have been introduced in order to identify fluid responders and non-responders without fluid challenge administration. Changes in cardiac output induced by the Passive Leg Raising (PLR) test reliably predicted the increase in cardiac output to volume expansion. New approaches have been recently developed based on changes in respiratory dynamics, such as a transient increase in tidal volume, or a lung recruitment maneuver or an end-expiratory occlusion (EEO) test. The EEO leaded to an increase in venous return, cardiac preload and stroke volume in preload-responsive patients. The authors found that an increase in cardiac output ≥ 5% during a 15-s EEO reliably predicted its response to a 500-ml saline infusion. However, in order to identify the rapid and transient increase in cardiac index during the EEO, continuous and instantaneous cardiac output monitoring is necessary. Pulse contour analysis methods provide a beat-to-beat estimation of cardiac output and had been used in most of studies validating the EEO test. Carotid doppler is a non-invasive, bedside, easy to use ultrasound technique that measuring blood flow peak velocity (CDPV) and duration of systolic component of each cardiac cycle (from the onset to dicrotic notch- Flow time - FT) allows a reliable estimation of fluid status and could be an interesting alternative to track changes in SV and cardiac output.