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Shock clinical trials

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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: NCT04143893 Recruiting - Cardiogenic Shock Clinical Trials

The Current Status and Clinical Outcomes of Patients With Cardiogenic Shock II

RESCUE II
Start date: May 30, 2019
Phase:
Study type: Observational [Patient Registry]

The investigation of patient characteristics and prognostic factors of the patients presented with cardiogenic shock (CS) will guide us to identify the better management strategy for these critically ill patients. Mechanical circulatory support (MCS) may improve the prognosis of some of severe subset of CS patients. The better understanding of the indications of initiation and weaning of MCS will improve the prognosis of critically ill CS patients.

NCT ID: NCT04141410 Recruiting - Sepsis Clinical Trials

Global Longitudinal Strain Assessment in Cardiogenic Shock During Sepsis

GLASSES-1
Start date: October 21, 2019
Phase:
Study type: Observational

Cardiogenic shock is a condition of low cardiac output that represents the end of a progressive deterioration of cardiac function. The main cause is ischemic heart disease but there are several causes of non-ischemic nature including sepsis. Sepsis is characterized by a picture of organ dysfunction caused by an altered response of the body to an infection. Its most serious form is septic shock, defined as a picture of sepsis in which the underlying abnormalities in the cardiovascular system and cellular metabolism are such as to increase mortality. An organ failure correlates directly with the function of others and this interdependence is especially evident when a cardiovascular failure is established. 3 Cardiac dysfunction in sepsis can be defined as that of a syndrome characterized by low cardiac output not related to myocardial ischemia. The use of levosimendan in cardiogenic shock during sepsis was first described in a 2005 case report. Since then there have been small studies and other case reports that have shown improvements in right and left ventricular contractility, ventricular coupling, cardiopulmonary performance, global oxygen transport, renal and splanchnic perfusion when compared to dobutamine and placebo. Other beneficial effects of this drug have emerged, including an anti-inflammatory, antioxidant and antiapoptotic action with a possible protection from ischemia-reperfusion damage. The present study aims to evaluate the correct use of levosimendan, after the occurrence of cardiogenic shock on a low cardiac index has been ascertained, with the aim of weaning from inotropic drugs in infusion.

NCT ID: NCT04138394 Recruiting - Shock Clinical Trials

VItamin C in Thermal injuRY: The VICToRY Trial

VICToRY
Start date: July 24, 2020
Phase: Phase 3
Study type: Interventional

This study aims to show that giving high dose, intravenous vitamin C in addition to standard care to burned critically ill patients will be associated with less organ dysfunction, improved survival and a quicker rate of recovery. In this study, all patients will receive standard care and of the patients will also receive high dose intravenous vitamin C, while the other half of patients will receive placebo.

NCT ID: NCT04130230 Recruiting - Clinical trials for Sepsis, Septic Shock

Adjuvant Use of Neostigmine in Sepsis and Septic Shock.

Start date: March 6, 2019
Phase: Phase 2
Study type: Interventional

The inflammatory response represents an important, central component of sepsis. Therefore, it is believed that blunting inflammation will decrease mortality. In vivo test series with mice that had undergone cecal ligation and puncture (recognized sepsis model), physostigmine salicylate significantly inhibited the release of various cytokines (tumor necrosis factor α, interleukin1β, and interleukin 6). These results were similar to those obtained by vagus nerve stimulation. In animal sepsis model using physostigmine not only decreased inflammation but also, diminished the decrease in blood pressure following infection. Animals treated with the peripheral choline esterase inhibitor neostigmine showed no difference compared with physostigmine-treated animals. Therefore, this study aims to investigate the efficacy of choline esterase inhibitors as adjuvant therapy in patients with sepsis or septic shock. Outcome measures include: percentage reduction in procalcitonin blood level, percentage of patients achieving significant reduction in procalcitonin levels, Mean Sequential Organ Failure Assessment score, percentage decrease in lactate dehydrogenase blood level, length of stay in hospital intensive care unit, and in hospital mortality.

NCT ID: NCT04114162 Recruiting - Shock, Septic Clinical Trials

Fluid Overload Quantification in Septic Shock

FOTOShock
Start date: January 1, 2020
Phase:
Study type: Observational

Fluid management in septic shock patients remain a great challenge. Insufficient fluid filling lead to hypovolemia, organ failure and increased death, whereas fluid overload was associated to an increased morbidity and mortality in several studies. Several invasive and non invasive strategies have been developed during the past years to monitor the hemodynamic state of septic shock patients, but no method has been validated to objectively quantify fluid overload in septic shock patients. The Body Composition Monitor (BCM) allow for measurement of total body water (TBW), extracellular water (ECW) and intracellular water (ICW) volumes using bioimpedancemetry. The BCW is daily used in patients who undergo renal dialysis to assess the effectiveness of fluid removal. The BCM has never been validated in septic shock patients. The aim of the study is to investigate the accuracy of the BCM to measure the variation of the TBW during a fluid challenge of 500 ml of saline during the early phase of septic shock.

NCT ID: NCT04110418 Recruiting - Neonatal Sepsis Clinical Trials

Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate

Start date: February 19, 2019
Phase: Phase 2
Study type: Interventional

A randomized, prospective study comparing methylene blue versus terlipressin in treatment of catecholamines resistant shock in preterm neonate

NCT ID: NCT04102371 Recruiting - Shock Clinical Trials

Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis

PRoMPT BOLUS
Start date: August 25, 2020
Phase: Phase 3
Study type: Interventional

The objectives of this multicenter pragmatic clinical trial are to compare the effectiveness and relative safety of balanced fluid resuscitation versus 0.9% "normal" saline in children with septic shock, including whether balanced fluid resuscitation can reduce progression of kidney injury.

NCT ID: NCT04089072 Recruiting - Septic Shock Clinical Trials

Methylene Blue as a Third-line Vasopressor in Septic Shock

Start date: December 1, 2019
Phase: Phase 2
Study type: Interventional

A randomized, prospective study comparing ProvayBlue® to standard care with multiple sympathomimetic vasopressors.