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Shock, Septic clinical trials

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NCT ID: NCT02835157 Completed - Septic Shock Clinical Trials

Balanced Crystalloid vs. Saline in Children With Septic Shock

Start date: April 1, 2017
Phase: N/A
Study type: Interventional

Fluid resuscitation is the cornerstone of pediatric shock management; current practices of fluid resuscitation in children are not evidence based. Normal saline is the preferred crystalloid recommended during initial resuscitation in shock, as the incidence of hyponatremia is lower with normal saline compared to all other fluids available and commonly used. However, normal saline has its own set of undesired physicochemical actions. Emerging data strongly indicate the increased incidence of hyperchloremia, metabolic acidosis and consequently, acute kidney injury associated with infusion of large volumes of normal saline. Balanced salt solutions or crystalloids, which have composition resembling plasma but lower chloride concentrations than normal saline, clearly decrease the risk of hyperchloremia and metabolic acidosis in adult as well as pediatric studies when used during the peri-operative period. The results favored balanced solutions in comparison to normal saline. Recent systematic reviews comparing balanced or buffered versus non-buffered fluids for surgery in adults favored the former solution as the metabolic derangements were less with the use of this type of fluid. In adult patients, the two solutions have been compared in various other settings as well such as in traumatic brain injury and in shock. The results favored balanced solutions in comparison to normal saline. However, in the non-surgical setting there is a paucity of evidence on the use of these solutions in children with shock and more evidence needs to be generated to support or refute the use of this fluid as compared to normal saline. Given this background, the investigators decided to compare the effect of two solutions on the incidence of acute kidney injury in children resuscitated with either of the two fluids. Children receiving at least one fluid bolus at 20 ml/kg in the first hour would be enrolled and followed up for the proposed outcome variables. The investigators plan to enroll 708 patients over a period of 3 years. The investigators believe that the proposed study will provide answer to the research question of which of the fluids could be preferred for resuscitation.

NCT ID: NCT02820675 Completed - Sepsis Clinical Trials

Quality Improvement in Infection COntrol and Sepsis Management in MOdel Regions

icosmos
Start date: August 2015
Phase: N/A
Study type: Interventional

The German Quality Network Sepsis is an association trying to improve quality of care for patients with sepsis, severe sepsis and septic shock or being in risc thereof. The icosmos trial investigates the impact on the use of routine data, a risk adjustment algorithm and feedback to all hospitals as well as a structured implementation for regular screening for deteriorating patients, and education on in-hospital mortality.

NCT ID: NCT02814708 Completed - Clinical trials for Toxic Shock Syndrome

Clinical Trial of the BioMed rTSST-1 Variant Vaccine in Healthy Adults

Start date: May 2016
Phase: Phase 2
Study type: Interventional

Toxic Shock Syndrome (TSS) is a severe condition with high morbidity and mortality from the hosts overwhelming inflammatory response and cytokine storm. Staphylococcal superantigen toxins are the main causative agents. Toxic shock syndrome toxin (TSST-1) being responsible for almost all of menstruation associated and more than 50% of all other cases. There is no specific therapy. The aim of this study is to extend the safety and tolerability of two doses of the BioMed recombinant toxic shock syndrome toxin (rTSST-1) Variant Vaccine after one to three vaccinations in healthy adults. The second aim of the study is to measure immunogenicity and persistence of antibodies which produced in response to treatment with the BioMed rTSST-1 Variant Vaccine over a period of 12 months. These antibodies are expected to be important in prevention and mitigation of the diseases. 140 healthy adults, male and female, age 18-64 years will be assigned to 7 groups comprising two doses of the vaccine or adjuvant at the Department of Clinical Pharmacology of the Medical University of Vienna. The patients will be monitored for vital signs, hematology, clinical chemistry, and antibodies against TSST-1. Immunization will be repeated 3 months after the first with the same dose and 6 months after the second immunization in the respective groups. Antibodies will be determined through monitoring TSST-1 binding antibodies as assessed through ELISA and neutralizing antibodies (exploratory endpoint) as assessed by inhibition of T cell activation (3H Thymidine incorporation; ≥ 50%).

NCT ID: NCT02805049 Completed - Septic Shock Clinical Trials

Pharmacokinetic Study on Echinocandins for Patients With Septic Shock Following Secondary Peritonitis

Start date: January 28, 2017
Phase: Phase 4
Study type: Interventional

The main objective of this study is to describe the pharmacokinetics of the prescribed echinocandins for septic shock with secondary peritonitis for which intra-abdominal fungal infection is suspected or proven.

NCT ID: NCT02782013 Completed - Sepsis Clinical Trials

Study of Progression of Community Acquired Pneumonia in the Hospital

PROGRESS
Start date: August 25, 2009
Phase:
Study type: Observational

Pneumonia is a common infectious disease of the lung, often requiring treatment in the hospital. Clinical scoring systems are available, identifying patients not requiring hospitalization. However, the course of disease of patients in the hospital remains hard to predict. While most patients will recover quickly, some will, despite appropriate treatment, develop a severe course leading to sepsis and systemic responses resulting in organ dysfunction. The PROGRESS study aims to identify clinical, genetic, and other molecular markers and combinations thereof predicting a severe course of pneumonia in the hospital. Such predictors will, for instance, support decisions on earlier transfer of patients to intensive care and thus improving outcome.

NCT ID: NCT02780466 Completed - Septic Shock Clinical Trials

Observational Study on Intubation in Septic Shock

INTUBATIC
Start date: May 2016
Phase:
Study type: Observational

Septic shock is common in intensive care and its mortality remains high. While new treatments have not improved survival, optimization of known and widely used techniques has allowed reduction in mortality. Thus improving care given to patients starts with making better use of existing resuscitation techniques. Among these practices, mechanical ventilation is widespread in the management of patients with septic shock. In large studies published in recent years in Europe and North America, 40 to 85% of patients receive invasive mechanical ventilation. It therefore appears that a significant proportion of patients are never intubated during treatment and management of their septic shock. There is no specific recommendation from critical care societies concerning mechanical ventilation in the treatment of septic shock. Apart from indisputable situations such as impaired consciousness or acute respiratoire distress, the decision whether to ventilate mechanically or not is left to the discretion of the physician. The aim of this study is to analyze intubation practice in septic shock patients and its impact on 28-day survival. This multicentric and observational study will be conducted in 30 French ICUs.

NCT ID: NCT02768740 Completed - Septic Shock Clinical Trials

Hydrocortisone 50 mg Every 6 Hours Compared to Hydrocortisone 300 mg Per Day in Treatment of Septic Shock.

HSHC00582434
Start date: April 2008
Phase: Phase 4
Study type: Interventional

We performed a multicenter, prospective, randomized, double-blind, pilot study in four adult medical intensive care units. Patients presenting septic shock were rapidly administered one of two regimens of hydrocortisone, either a 50-mg intravenous bolus every six hours during seven days (200-mg group) or a 100-mg initial bolus followed by a continuous infusion of 300 mg daily for five days (300-mg group). Hydrocortisone was stopped abruptly at the end of treatment.

NCT ID: NCT02750683 Completed - Septic Shock Clinical Trials

Norepinephrine Exerts an Inotropic Effect at the Early Phase of Human Septic Shock

Start date: October 2014
Phase: N/A
Study type: Observational

Norepinephrine (NE) is a potent vasopressor used in septic shock to reverse hypotension. Early infusion of NE was associated with a favorable clinical outcome in a large cohort of patients . When administered early, NE increases cardiac output (CO) in patients with septic shock . This effect was suggested to be mainly related to an increased cardiac preload via the α-adrenergic-mediated decrease in systemic venous capacitance . Whether NE exerts a positive effect on cardiac contractility through β1-adrenergic stimulation is unclear. On the one hand, the sensitivity of β1-adrenergic receptors can be abnormally reduced in septic conditions. On the other hand, such a sepsis-induced down-regulation of β1-adrenergic receptors may occur relatively late and thus, might not be observed when NE is administered early. Our study was designed to examine the inotropic effects of NE when administered in the early phase of human septic shock

NCT ID: NCT02750163 Completed - Clinical trials for Sepsis and Septic Shock

Circulating Free Hemoglobin and Microcirculation After Administration of Paracetamol in Febrile Septic Patient

Start date: July 5, 2017
Phase:
Study type: Observational

The aim of this study is to evaluate the effect of Acetaminophen on the main parameters of microcirculation, on the plasmatic levels of free hemoglobin/oxidative stress markers and on the expression of PD1/Pd-L1, in pyrexial septic patient.

NCT ID: NCT02748382 Completed - Sepsis Clinical Trials

Fluids in Sepsis and Septic Shock

FISSH
Start date: August 18, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Despite evidence of the physiologic benefits and possible lower mortality associated with low chloride solutions, normal saline remains the most wildly used fluid in the world. Given uncertainty about the impact of lower chloride versus higher chloride solutions on mortality, it is unlikely that clinical practice will change without new and direct RCT evidence. Editorials published in leading critical care journals have called for RCT's to address this important clinical question. The proposed feasibility RCT will investigate the feasibility of a large-scale trial directly comparing low chloride versus normal chloride for resuscitation in septic shock on patient-important outcomes such as mortality and AKI.