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Shock, Septic clinical trials

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NCT ID: NCT03802500 Recruiting - Clinical trials for ICU Acquired Weakness

Neurophysiological Diagnosis for ICU Septic Shock Patients

EDX
Start date: January 23, 2019
Phase:
Study type: Observational

Patients hospitalized in the Intensive Care Unit (ICU) are at risk for developing severe disabilities, physical or cognitive. In particular, ICU-acquired weakness is frequent. The causes of this weakness are multiple and the physiopathology is still not fully understood. Immobilization in bed and sepsis are known risk factors. ICU-acquired weakness has been associated with prolonged mechanical ventilation duration, and increased in ICU and hospital length of stay. It has also been associated with significant decrease in functional capacity and with higher mortality. An early screening using a specific diagnostic protocol could help improving the management of patients suffering from ICU acquired weakness. The aim of this study is to early detect ICU acquired weakness in patients suffering from septic shock and ventilated for more than 72 hours.

NCT ID: NCT03802136 Recruiting - Sepsis Clinical Trials

Multiple Biomarkers in ICU Sepsis Patients

Start date: December 30, 2018
Phase:
Study type: Observational

Acute kidney injury (AKI) is a common condition among sepsis patients in the intensive care unit (ICU) and is associated with high morbidity and mortality. Oxidative stress biomarkers were investigated in panels and were reported to predict renal failure in sepsis patients. Some biomarkers would be able to identify who will recover and not recover better than serum creatinine. Thus, a combining oxidative stress biomarkers are needed to predict the occurrence or progression of AKI in critically ill patients.

NCT ID: NCT03788837 Completed - Clinical trials for Septic Shock Hyperdynamic

Ilomedin in Septic Shock With Persistent Microperfusion Defects (I-MICRO)

I-MICRO
Start date: July 3, 2019
Phase: Phase 3
Study type: Interventional

Septic shock remains a major cause of death in critically ill patients. Alterations in microcirculation have long been proposed as a key pathophysiological factor of organ dysfunction and death in septic shock patients. Persistence of mottling, prolonged skin recoloration time and cyanosis of the extremities are the easily and frequently observed manifestations of these microcirculatory disorders. Ilomedin is a prostaglandin analog with a potent vasodilatory effect together with anti-thrombotic properties (inhibition of platelet aggregation) preferentially at the microcirculatory level. An increase in cardiac output with increased arterial oxygen delivery has been observed in clinical and preclinical studies with no episodes of hypotension. Improvement in mesenteric perfusion has moreover been observed in experimental sepsis using Ilomedin. Our group has furthermore reported that administration of Ilomedin in patients with refractory septic shock (peripheral hypoperfusion) resulted in a rapid and sustained improvement in peripheral perfusion. Altogether, Ilomedin may prevent or improve recovery of organ dysfunction in septic shock patients through recruitment of the microcirculation and, thereby, ultimately improve outcome.

NCT ID: NCT03788096 Recruiting - Sepsis Clinical Trials

Peer Support for Post Intensive Care Syndrome Self-Management

PS-PICS
Start date: April 20, 2020
Phase: N/A
Study type: Interventional

A prospective, 2-arm, single-blind, randomized controlled clinical feasibility trial design is planned. Forty CCI survivors will be randomized (1:1) to either the PS-PICS (peer support) intervention or usual care (control) group.

NCT ID: NCT03783091 Recruiting - Septic Shock Clinical Trials

A Trial of Vitamin B12 in Septic Shock

B12
Start date: August 5, 2019
Phase: Phase 2
Study type: Interventional

This study will randomize 20 septic shock patients to receive either a single 5 gram dose of IV vitamin B12 (Cyanokit® Meridian Medical Technologies, Columbia, MD) versus placebo in addition to standard of care to test the feasibility of completing clinical and laboratory protocols.

NCT ID: NCT03782454 Recruiting - Sepsis Clinical Trials

Quantification of Bacterial DNA in Sepsis

Start date: January 7, 2019
Phase:
Study type: Observational

The purpose of this study is to evaluate whether bacterial DNA clearance measured with droplet digital Polymerase Chain Reaction (ddPCR) can be used as a measure of bacterial load in septic intensive care patients. Furthermore, the aim is to examine a possible relation between clearance of bacterial DNA and clinical outcome in the septic patient, and the relationship between concentration of beta-lactam antibiotics and the clearance of bacterial DNA.

NCT ID: NCT03765489 Completed - Septic Shock Clinical Trials

Electrical Muscle Stimulation in the Development of Acquired Weakness in Patients With Severe Sepsis and Septic Shock

Start date: November 18, 2016
Phase: N/A
Study type: Interventional

The aim of this study is to compare the effect of EMS and conventional physical therapy on strength and muscle mass and development in adult patients with severe sepsis and septic shock.

NCT ID: NCT03762005 Recruiting - Septic Shock Clinical Trials

Peripheral Perfusion Versus Lactate Targeted Fluid Resuscitation in Septic Shock

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

Persistent hyperlactatemia has been traditionally considered as representing tissue hypoxia, and lactate normalization is recommended as a resuscitation target by the Surviving Sepsis Campaign (SSC). However, other sources contribute to hyperlactatemia such as sustained adrenergic activity and impaired lactate clearance. Only hypoperfusion-related hyperlactatemia might be reversed by optimizing systemic blood flow. Fluid resuscitation (FR) is used to improve cardiac output (CO) in septic shock to correct hypoperfusion. Nevertheless, if persistent hyperlactatemia is not hypoxia-related, excessive FR could lead to flow overload. In addition, kinetics of recovery of lactate is relatively slow, and thus it might be a suboptimal target for FR. Peripheral perfusion appears as a promising alternative target. Abnormal capillary refill time (CRT) is frequently used as trigger for FR in septic shock. Studies demonstrated the strong prognostic value of persistent abnormal peripheral perfusion, and some recent data suggest that targeting FR on CRT normalization could be associated with less fluid loading and organ dysfunctions. The excellent prognosis associated with CRT recovery, the rapid-response time to fluid loading, its simplicity, and its availability in resource-limited settings, constitute a strong background to promote studies evaluating its usefulness to guide FR . The study hypothesis is that a CRT-targeted FR is associated with less positive fluid balances, organ dysfunctions, and at least similar improvement of tissue hypoperfusion or hypoxia, when compared to a lactate-targeted FR. To test this hypothesis, the investigators designed a clinical physiological, randomized controlled trial in septic shock patients. Recruited patients will be randomized to FR aimed at normalizing CRT or normalizing or decreasing lactate >20% every 2 h during the study period. Fluid challenges (500 ml in 30 min intervals) will be repeated until perfusion target is achieved, or dynamic predictors of fluid responsiveness become negative, or a safety limit is reached. The design of our study is aimed at: a) determining if CRT targeted resuscitation is associated with less fluid resuscitation and fluid balances; b) determining if this strategy is associated with less organ dysfunctions; and c) if it results in similar improvement in markers of tissue hypoperfusion or hypoxia such as hepato-splanchnic blood flow or microcirculatory perfusion.

NCT ID: NCT03756220 Completed - Sepsis Clinical Trials

Ascorbic Acid and Thiamine Effect in Septic Shock

ATESS
Start date: December 1, 2018
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate the efficacy of early metabolic resuscitation with combination therapy using vitamin C and thiamine in improving organ function and survival in patients with septic shock.

NCT ID: NCT03754257 Recruiting - Sepsis Clinical Trials

Effects of Electrical Stimulation for Preventing Loss of Muscle Mass in Patients With Sepsis

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

Background: Electrical stimulation has been used in critical patients as an adjunct strategy of early rehabilitation. In septic or septic shock patients there are reports of only two studies in the literature, with conflicting results. Objective: To evaluate the effects of electrical stimulation in the prevention of muscle mass loss in patients admitted to the ICU with sepsis or septic shock. Methods: This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a diagnosis of sepsis or septic shock (including patients with sepsis due to the new coronavirus - COVID-19) will be randomly assigned to experimental group and sham group. They will be evaluated in relation to muscle mass, peripheral muscle strength and functional status. They will also be submitted to the collection of inflammatory, metabolic, damage and muscular trophism markers. Expected results: Electrical stimulation is expected to be able to prevent loss of muscle mass in patients admitted to the ICU with sepsis or septic shock. In addition, it is expected to be able to preserve strength in this population without increasing the pro-inflammatory or metabolic response.