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Shock, Septic clinical trials

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NCT ID: NCT04339868 Recruiting - Septic Shock Clinical Trials

Terlipressin for Refractory Septic Shock

TERESEP
Start date: April 3, 2020
Phase: Phase 2
Study type: Interventional

Norepinephrine was recommended as the first vasopressor for septic shock resuscitation. For the patient who did not response to high dose norepinephrine, epinephrine was recommended. Vasopressin was also recommended as an alternative vasopressor, in case patient did not response to norepinephrine and or epinephrine. Terlipressin, a selective V1 receptor binding with long half life, was reported that it main action is to increase blood pressure via the different mechanism from norepinephrine and epinephrine. To use terlipressin, combine with norepinephrine and or epinephrine among refractory septic shock, could decrease the usage dose of norepinephrine and epinephrine as well as lower the side effects of too high adrenergic stimuli.

NCT ID: NCT04306419 Recruiting - Sepsis Clinical Trials

Observational Trial on Cytokine Adsorption in Sepsis

OuTCASt
Start date: November 15, 2020
Phase:
Study type: Observational

To determine the specific population of critically ill septic patients who benefit most from cytokine adsorption therapy with the HA-380 cartridge. Benefit of the treatment will be assessed on the basis of: - The scope of the effect of cytokine adsorption therapy in this specific population of critically ill patients expressed by cytokine variability within the patients - The scope of cytokine changes in passing the adsorption cartridge my measuring cytokine levels in the patient's blood directly before passing through the cartridge and directly after having passed through the cartridge. - The scope of changes in organ dysfunction expressed by SOFA scores that are repeatedly calculated during the treatment with cytokine adsorption and then daily until day 7 of the ICU treatment. - The scope of changes on cellular function on immune cells in serum samples taken before and after cytokine adsorption therapy. - The scope of removal of anti-infective drugs from the blood in passing through the cytokine adsorption cartridge by measuring antibiotic drug levels in the patients blood during the cytokine adsorption therapy - 30 day and 90 day mortality and location status in survivors

NCT ID: NCT04288635 Recruiting - Septic Shock Clinical Trials

Impact of Metabolite Supplementation to Restore Mitochondrial Dysfunction During Septic Shock: a Preclinical Study

MEFDASE
Start date: July 9, 2020
Phase:
Study type: Observational [Patient Registry]

Septic shock is defined as a subset of sepsis with severe metabolism alterations, leading to organ failure. Septic shock is associated with a high mortality, around 40% according to the SEPSIS 3 definition. Metabolic alterations are responsible for lactic acidosis, and results in mitochondrial dysfunction. This study aims at evaluate the impact of exogenous metabolites on restoring mitochondrial function in septic shock patients with lactate acidosis. Mitochondrial metabolism (quantitative analysis, mitochondrial function) in intact Peripheral Blood Mononuclear Cells (PBMC) will be isolate and analyse from patients at the early phase of septic shock (admission), at day 2 and 4. Participant's medical history will be recorded: renal and liver metabolism, severity scores and outcomes and the need for supportive care in the intensive care unit (ICU) until 28 days after admission. Furthermore, the investigators will evaluate wether selected metabolites added to the cell culture medium may improve mitochondrial metabolism.

NCT ID: NCT04281277 Recruiting - Septic Shock Clinical Trials

Relation Between Mean Arterial Pressure and Renal Resistive Index in the Early Phase of Septic Shock

SEPSIR
Start date: June 6, 2020
Phase: N/A
Study type: Interventional

This study evaluates if improvement of renal resistive index when mean arterial pressure increase (at 65 mmHg to 85 mmHg) in early phase of septic shock is predictive of better renal survival.

NCT ID: NCT04259567 Recruiting - Septic Shock Clinical Trials

Improvement of Cerebrovascular Autoregulation in Patients With Septic Shock Due to Cytokine Elimination

SepsAR3
Start date: June 8, 2020
Phase: N/A
Study type: Interventional

The trial investigates the effect of cytokine elimination in patients with septic schock and acute renal failure with need for renal replacement therapy on the integrity of cerebrovascular autoregulation. Patients with inclusion criteria were randomly assign in either use of CytoSorb filter integrated in renal replacement therapy versus non additional filter an renal replacement therapy alone. Cerebrovascular autoregulation will be measured with transcranial Doppler ultrasound and correlation with arterial blood pressure.

NCT ID: NCT04231695 Recruiting - Septic Shock Clinical Trials

Extracorporeal Cytokine Removal in Patients With Septic Shock in an Adult Intensive Care Unit

Start date: December 1, 2019
Phase:
Study type: Observational

Goals Primary: compare changes in norepinephrine requirements before and after hemoperfusion (HP) treatment. Secondary: demonstrate the decrease in levels of IL-6 , assess the total and individual change of SEQUENTIAL ORGAN FAILURE ASSESSMENT (SOFA), establish the resolution of shock , clearance of lactate , and mortality at discharge from INTENSIVE CARE UNIT (ICU), at 30 and 60 days.

NCT ID: NCT04203524 Recruiting - Sepsis Clinical Trials

Procalcitonin and Antimicrobial Utilization in Critically Ill Cancer Patients With Sepsis

Pro-Can
Start date: August 21, 2019
Phase: N/A
Study type: Interventional

Studies have demonstrated that the use of a procalcitonin (PCT)-guided algorithm in combination with clinical judgment was associated with reduced antibiotic use without impacting mortality or treatment failure. Though several studies have evaluated the use of PCT in critically ill patients, there are limited studies that evaluated PCT in patients with cancer and many of the currently available studies have excluded immune-compromised patients. This is a randomized controlled trial that aims to evaluate the impact of a procalcitonin-guided algorithm on antibiotic utilization in critically ill cancer patients with sepsis. In addition, the study aims to evaluate the predictive value of PCT for predicting mortality and positive cultures.

NCT ID: NCT04182737 Recruiting - Sepsis Clinical Trials

Efficacy and Safety of Therapy With IgM-enriched Immunoglobulin With a Personalized Dose vs Standard Dose in Patients With Septic Shock.

IgM-FAT
Start date: May 1, 2020
Phase: Phase 3
Study type: Interventional

In patients with septic shock, low levels of circulating immunoglobulins are common and they are kinetic, particularly of immunoglobulin M (IgM), seems to be related with clinical outcome. These observations, combined with the pivotal role of immunoglobulins on host immune response to infections, led to consider therapy with polyclonal intravenous immunoglobulins a promising option in patients with septic shock. IgM-enriched preparations have been used since now most of all at a standard dose recommended by the producer although a more tailored approach may improve patients' outcomes. This study hypothesizes that in patients with septic shock and low IgM immunoglobulins titers at shock onset, adjunctive treatment with a personalized dose of IgM-enriched immunoglobulins based on IgM serum titers of the patient may reduce mortality compared to a standard dose of IgM-enriched immunoglobulins. The study is designed as a multicentre, national, interventional, randomized, single-blinded, prospective, investigator-sponsored, two arms study. Patients will be randomly assigned to IgM titer-based treatment or flat treatment group in a 1:1 ratio. One group of patients will receive IgM-enriched immunoglobulins adjunctive treatment in a standard dose of 250mg/kg for 3 days. The other group will receive IgM-enriched immunoglobulins adjunctive treatment in a variable dose calculated taking note of the extent of IgM deficit, in order to achieve an IgM threshold value of 100 mg/dL or above. IgM preparation will be administered in this group up to the withdrawal of vasoactive drugs with a maximum allowed of 7 days. The confirmation of the efficacy of a tailored strategy for IgM-enriched immunoglobulin administration in reducing the mortality rate among patients with septic shock and low IgM titers will lead to a revision of the current clinical practice in the use of this adjunctive treatment.

NCT ID: NCT04156451 Recruiting - Septic Shock Clinical Trials

Effect of Fluid Deresuscitation With Central Venous Pressure Target 0-4 mmHg in Septic Shock Patients

Start date: November 14, 2019
Phase: N/A
Study type: Interventional

A scientific research to prove the safety and effectiveness of TVS 0 - 4 mmHg as a target of resuscitation using furosemide, to improve Perfused Vessel Density (PVD) > 25 mm / mm2, AKI stage (based on KDIGO criteria), CI > 2.5 cc / min / m2 , prevent the incidence of intubation, reduce the duration of ventilator use <120 hours and reduce the length of ICU stay in patients with septic shock after resuscitation

NCT ID: NCT04152174 Recruiting - Septic Shock Clinical Trials

Safety and Efficiency of Combined Extracorporeal Blood Purification in Neurosurgical ICU. Prospective RCT

NEUROCOMB
Start date: April 10, 2018
Phase: N/A
Study type: Interventional

To assess the efficiency and safety of combined extracorporeal blood purification in patients with septic shock in Neurosurgical ICU in comparison with the efficiency and safety of the continuous renal replacement therapy (CRRT).