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Shock, Septic clinical trials

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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: NCT04302584 Completed - Acute Kidney Injury Clinical Trials

Norepinephrine / Vasopressin Combination for Resuscitation in Septic Shock

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Although norepinephrine is commonly used and is the recommended agent for the treatment of hypotension in volume-resuscitated hyperdynamic septic shock, Low doses of vasopressin may be added to norepinephrine to maintain arterial blood pressure in refractory septic shock and to decrease exposure to norepinephrine. The aim of the work is to compare the effect of norepinephrine alone and Norepinephrine/vasopressin combination on hemodynamics and tissue perfusion in septic shock patients.

NCT ID: NCT04295993 Not yet recruiting - Septic Shock Clinical Trials

Methylene Blue and Microcirculation in Septic Shock

Start date: March 10, 2020
Phase: Phase 3
Study type: Interventional

This trial aims to identify the effects of methylene blue infusion on the the micro-circulation in patients with septic shock. The investigators will evaluate various indices of micro-circulation such as: microvascular flow index, the flow heterogeneity index, the total vessel density, the perfused vessel density, and the proportion of perfused vessels.

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: NCT04282252 Not yet recruiting - Septic Shock Clinical Trials

The Effect of Restrictive Fluid Management on Cardiac Function and Glycocalyx Degradation

Start date: February 24, 2020
Phase: Phase 4
Study type: Interventional

The study aims to compare the effects of restrictive fluid management on cardiac dysfunction and vascular integrity in septic shock patients. To achieve this, patients with septic shock according to Sepsis-3 criteria admitted to several Intensive Care Units in Sweden and Denmark will be randomized to receive restrictive respectively standard fluid therapy. Blood test from these patients will be analyzed for several biomarkers of cardiac function and glycocalyx degradation. Echocardiography will also be performed to further investigate cardiac function.

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: NCT04257838 Not yet recruiting - Sepsis Clinical Trials

Monitoring of Piperacillin-Tazobactam and Meropenem Plasmatic Levels in Critical Patients

Start date: February 15, 2020
Phase:
Study type: Observational

The aim of this study is to establish the Piperacillin-Tazobactam and Meropenem Plasmatic Levels to know if it´s necessary to make some adjustment in the recommended dose regimen.

NCT ID: NCT04257136 Active, not recruiting - Sepsis Clinical Trials

VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients

Start date: February 17, 2020
Phase: Phase 2
Study type: Interventional

This study is being conducted to evaluate the safety and effectiveness of VBI-S in elevating the blood pressure of septic shock patients with absolute or relative hypovolemia.

NCT ID: NCT04231994 Completed - Septic Shock Clinical Trials

Therapeutic Plasmaexchange in Early Septic Shock

EXCHANGE
Start date: June 1, 2018
Phase: Phase 2
Study type: Interventional

Sepsis is defined by the occurrence of critical organ dysfunction in the context of infection. Unfortunately, its incidence appears to be rising, and the mortality of septic shock remains extraordinary high (> 60%). Death in sepsis arises from shock and multi organ dysfunction that are - at least in part - triggered by an inadequate response of the host's immune system to the infection. Given the injurious role of 1) this overwhelming immune response and 2) the consumption of protective plasmatic factors (e.g. vWF cleaving proteases, hemostatic factors etc.) while the disease is progressing the investigators hypothesize that early therapeutic plasma exchange (TPE) in the most severely ill individuals might improve hemodynamics, oxygenation and ultimately survival. This therapeutic strategy combines 2 major aspects in 1 procedure: 1. removal of harmful circulating molecules and 2. replacement of protective plasma proteins. The investigators designed the EXCHANGE trial to analyze in a randomized fashion the benefit of TPE as an add-on treatment to state of the art standard sepsis care. Only patients with early septic shock (< 24 hrs) and high catecholamine doses (norepinephrine > 0.4 ug/kg body weight/min) will be included. Those in the treatment group will receive 1 TPE within 2 hours following randomization. The primary outcome is norepinephrine dose 6 hrs after randomization. The recruitment period is 2 years and will be performed at the Hannover medical School University hospital in Germany. Secondary endpoints (including organ dysfunction as well as biochemical markers of inflammation and coagulation) will be assessed on day 1-8 and day 28 after TPE. The investigators hope to demonstrate a potential benefit of an additive treatment approach to improve the outcome of patients suffering from septic shock.