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Shock, Septic clinical trials

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NCT ID: NCT04934943 Recruiting - Sepsis Clinical Trials

"Mini Fluid Challenge Assessment: a Comparison Among Three Hemodynamic Tools"

MINI3
Start date: October 22, 2021
Phase:
Study type: Observational

The mini fluid challenge (mini_FC) is a functional hemodynamic test which has been used in different clinical contexts to assess fluid responsiveness. This test is performed by rapidly injecting a small aliquot of fluid (100 ml over 1 minute), which is followed by the infusion of the residual aliquot of fluid. Since the threshold of the mini_FC identified by the literature is rather small (5% of stroke volume (SV) increase after the 100 ml bolus to discriminate between responder and non-responder), it is crucial that the hemodynamic tool assessing this change could be reliable. Moreover, the SV changes with inspiratory/expiratory movements and the increase after the mini_FC should also consider the physiological fluctuations of the SV. In the literature this test has been performed by means of tolls with different least significant change of the SV. The least significant change (LSC) represents the smallest difference between successive measurements of SV that can be considered to be a real change and not attributable to chance. The purpose of this study is to assess the agreement among MOSTCARE system (4.5& of SV LSC described in the literature) and the echocardiography (about 10% of SV LSC described in the literature) with the PICCO system (about 1% of SV LSC described in the literature - considered the gold standard) in discriminating fluid responsiveness after a mini_FC

NCT ID: NCT04931485 Recruiting - Septic Shock Clinical Trials

Protocolised Early De-Resuscitation in Septic Shock (REDUCE)

REDUCE
Start date: July 19, 2021
Phase: N/A
Study type: Interventional

Background: Recent studies have questioned the safety of current fluid resuscitation strategies in patients with septic shock as prospective and observational data suggesting that the resulting fluid overload is associated with mortality. Two strategies have evolved to prevent or minimize fluid overload: restrictive fluid administration or active removal of accumulated fluid. While several small trials show benefits with a restrictive fluid administration regimen, active protocolized de-resuscitation was scarcely evaluated. The combination of both strategies yet warrants systematic evaluation. Aim: This study aims to assess the efficacy and feasibility of an early active de-resuscitation protocol in patients with septic shock. We hypothesize that the application of a structured early de-resuscitation protocol versus standard of care will lead to less fluid overload at day three after ICU admission. Study Intervention: Patients admitted to the ICU with confirmed or suspected septic shock (Sepsis-3 definition) will be randomized (1:1) to either the intervention or standard of care. In the intervention arm, patients are managed according to the REDUCE fluid management protocol during resuscitation and de-resuscitation.

NCT ID: NCT04931225 Recruiting - Septic Shock Clinical Trials

LANdiolol MIcrocirculatory Effects During Septic chOc (MILANOS)

MILANOS
Start date: July 18, 2022
Phase: Phase 3
Study type: Interventional

The objectives of this study are to evaluate the effect of continuous intravenous Landiolol injection (from 0.5 to 10 µg/kg/min during 12 hours ) up to a 15% decrease in Heart Rate (HR) on microcirculatory vascular reactivity vs. usual tachycardia management and evaluate the hemodynamic effects of Landiolol vs. usual management in patients with septic shock.

NCT ID: NCT04915625 Recruiting - Septic Shock Clinical Trials

A Prediction Model of 28-day Mortality in Septic Shock

Start date: December 1, 2020
Phase:
Study type: Observational

This clinical study adopts the design of cohort research, selects the sepsis shock patients admitted to our hospital ICU as the research object, takes the 28-day mortality rate as the outcome index, collects the baseline data of the patient, the severity of the disease, vital signs, the main infection site, the laboratory-related index, the treatment method and other data, screens out the risk factors affecting the sepsis shock 28-day mortality rate and constructs the prediction model accordingly, analyzes the prediction model with the subject's working characteristic curve (ROC). The recognition ability of the model is calculated by the area under the ROC curve (AUC) and the ability of the model to predict 28-day mortality with SOFA and APACHE II.

NCT ID: NCT04913181 Not yet recruiting - Septic Shock Clinical Trials

Artificial Intelligence for Sepsis Prediction in ICU

AICUSepsis
Start date: June 1, 2021
Phase:
Study type: Observational

The development of sepsis prediction model in line with Chinese population, and extended to clinical, assist clinicians for early identification, early intervention, has a good application prospect. This study is a prospective observational study, mainly to evaluate the accuracy of the previously established sepsis prediction model. The occurrence of sepsis was determined by doctors' daily clinical judgment, and the results of the sepsis prediction model were matched and corrected to improve the clinical accuracy and applicability of the sepsis prediction model.

NCT ID: NCT04910893 Completed - Septic Shock Clinical Trials

Cytokine Adsorption in Severe, Refractory Septic Shock

Start date: November 27, 2014
Phase: N/A
Study type: Interventional

Septic shock and the underlying dysregulated inflammatory host-response remain a major contributor to mortality in critically ill patients. Cytokine adsorption represents an attractive approach to the treatment of septic shock. Nevertheless, its effect on circulating cytokine levels, as well as on the course of disease remains largely unassessed.

NCT ID: NCT04910841 Recruiting - Hypotension Clinical Trials

Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine

GALI
Start date: September 11, 2023
Phase: N/A
Study type: Interventional

Glycemic imbalances are very common in shock patients admitted to intensive care units. A blood glucose control every 2 hours is routinely performed in patients requiring insulin therapy. In practice, we use a protocol and management software called "CPG" (Personalized Control of Blood Glucose). This involves taking capillary samples from the fingertips. In addition to the pain generated, local haematomas and sensitivity disorders have been described. Night-time sampling also leads to repeated awakenings. The "CGM GUARDIAN 2" system has been validated for the measurement of glucose in interstitial fluid in insulin-dependent diabetic patients. An electrode is placed on the patient's abdomen or arm for up to 6 days. This electrode consists of a needle that is inserted subcutaneously only during the placement. The sugar level is read using a sensor placed on the electrode and an insulin pump (which will not deliver therapy (for our study) and which will be used only as an information reader to know the glucose level and trends). Interstitial fluid is automatically drawn from the electrode every minute and averaged every 5 minutes. This device has not yet been validated in resuscitation patients.

NCT ID: NCT04884854 Completed - Septic Shock Clinical Trials

Efferon LPS Hemoperfusion for Treatment of Patients With Septic Shock

Start date: September 13, 2019
Phase:
Study type: Observational

Sepsis is a global healthcare burden sepsis, it reaches 20-30 million cases annually (WHO data). Numerous studies have shown that extracorporeal hemoperfusion therapies that eliminate endotoxin and\or excess of cytokines improve treatment outcomes in patients with septic shock. Aim of the study: to evaluate safety and feasibility of clinical use of an extracorporeal blood adsorber based on a hypercrosslinked styrene-divinylbenzene copolymer with immobilized lipopolysaccharide (LPS)-selective ligand designed to remove endotoxins from the bloodstream to treat patients with septic shock.

NCT ID: NCT04870892 Recruiting - Septic Shock Clinical Trials

Effects of Norepinephrine and Volume Expansion in Capillary Refill Time in Septic Shock

NOVECAR
Start date: January 15, 2021
Phase:
Study type: Observational

The purpose of this study is to assess the effect of norepinephrine and fluid expansion on capillary refill time during septic shock.

NCT ID: NCT04855786 Active, not recruiting - Sepsis Clinical Trials

External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients

Start date: January 13, 2022
Phase: N/A
Study type: Interventional

To demonstrate that external drainage of thoracic duct lymph during sepsis results in a reduction in circulating pro-inflammatory cytokines. To demonstrate safety and feasibility of early thoracic duct cannulation and external lymph drainage for up to 7 days in adult surgical intensive care patients. To explore other biochemical and physiological endpoints that can be used for the design of future randomized controlled trials and estimate effect size of external drainage.