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Shock, Septic clinical trials

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NCT ID: NCT02203630 Terminated - Sepsis Clinical Trials

Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients

Start date: August 2014
Phase: Phase 4
Study type: Interventional

Septic shock is a condition that is marked by severe infection causing hypotension requiring vasopressors to maintain adequate perfusion to vital organs. The Surviving Sepsis campaign, an international organization formed for the purpose of guiding the management of sepsis and septic shock, currently recommends norepinephrine as the first-choice vasopressor for septic shock. Phenylephrine, a vasopressor FDA-approved for use in septic shock, is recommended as an alternative vasopressor when septic shock is complicated by tachyarrhythmia to mitigate cardiac complications. This recommendation is based solely on experience with no scientific evidence to support this recommendation. The investigators will conduct an open-label randomized controlled trial (RCT) directly comparing phenylephrine and norepinephrine, two FDA-approved vasopressors that are both used in clinical practice for the management of septic shock. The investigators will perform this study with a population of patients that have septic shock to complete the following aims: Aim 1: Determine the incidence of tachyarrhythmias. Aim 2: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a lower heart rate. Aim 3: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a higher incidence of new tachyarrhythmias. Aim 4: Determine which vasopressor, phenylephrine or norepinephrine, is associated with less time in tachyarrhythmia. Aim 5: Determine which vasopressor, phenylephrine or norepinephrine, is associated with fewer complications, including cardiac complications. The investigators hypothesize that in this setting, phenylephrine will improve the management of septic shock when used as a "first choice" vasopressor by: 1. Decreasing the mean heart rate 2. Decreasing the incidence of new tachyarrhythmias 3. Decreasing the amount of time spent in tachyarrhythmia for patients who develop new onset and recurrent tachyarrhythmias 4. Decreasing the number of cardiac complications

NCT ID: NCT02195830 Not yet recruiting - Sepsis Clinical Trials

Inferior Vena Cava Collapsibility Index in Severe Sepsis

Start date: July 2014
Phase: N/A
Study type: Interventional

There is debate regarding the use of non invasive (ultrasound assessed) parameters of fluid volume status in patients with sepsis. To establish the role of inferior vena cava ultrasound in guiding fluid resuscitation we first need to define the inferior vena cava collapsibility index in this population of patients. The research question is: In adult patients with sepsis, severe sepsis and septic shock what is the mean baseline inferior vena cava collapsibility index (IVCCI) prior to fluid resuscitation.

NCT ID: NCT02188888 Completed - Septic Shock Clinical Trials

Echocardiographic and Arterial Pressure Waveform Changes After Reducing Heart Rate With Esmolol in Septic Shock Patients

Start date: December 2013
Phase: N/A
Study type: Observational

Clinical study suggests that beta-blockers by decreasing heart rate together with an increase in stroke volume do not negatively affect cardiac output allowing an economization of cardiac work and oxygen consumption in patients with septic shock. Whether this hemodynamic profile leads to an amelioration of myocardial performance is still unclear. The objective of the present study is therefore to elucidate whether a reduction in heart rate with esmolol is associated to an improvement of cardiac efficiency in patients with septic shock who remained tachycardic after hemodynamic optimization.

NCT ID: NCT02186522 Completed - Sepsis Clinical Trials

Immune Failure in Critical Therapy (INFECT) Study

INFECT
Start date: July 2014
Phase: N/A
Study type: Observational

Patients admitted to intensive care units (ICU) are at high risk of developing secondary infections, and this is in part due to dysfunction or failure of their 'germ killing' functions (the immune system). Our group has recently identified three signatures of immune system failure which can be readily detected on a blood sample, and importantly, appear to predict the chances of developing secondary infection. Such a test would have major benefits for the management of patients in intensive care if it can be translated into a test usable in everyday clinical practice. This study aims to validate our original findings in a cohort of patients from multiple ICUs, using a test which will be suitable for everyday clinical practice, and thus take the next step towards developing a market-ready test. Study hypothesis: Measurement of neutrophil CD88, monocyte HLA-DR and percentage Tregs will accurately predict the risk of nosocomial infection.

NCT ID: NCT02165501 Active, not recruiting - Clinical trials for Severe Sepsis or Septic Shock (ICD-10-GM, R65.0, R65.1)

Jena Sepsis Registry

JenaSepsisReg
Start date: January 2011
Phase: N/A
Study type: Observational [Patient Registry]

Despite the burden of severe sepsis and septic shock deficiencies in the quality of sepsis management are recognized. Investigators present a population-based registry with easy feasibility as part of German Center for Sepsis Control & Care (CSCC). All ICU patients of the Jena University Hospital, Germany will be screened for inclusion (severe sepsis or septic shock). Baseline data on ICU- and hospital care will be extracted from patient records at ICU discharge. The primary outcome is change in all-cause mortality from baseline to follow up at 6, 12, 24, 36, 48 and 60 months after diagnosis of sepsis. Follow-up data will be collected from the primary care provider of the patient. The registry may provide valid data on quality in sepsis care.

NCT ID: NCT02163473 Completed - Sepsis Clinical Trials

Hypoxia Inducible Factor 1 Alpha as a Novel Biomarker in Septic Shock

Start date: January 2013
Phase: N/A
Study type: Observational

The purpose of this research study is to determine if a chemical marker in the blood, hypoxia-inducible factor (HIF-1 alpha), can be used to predict subject's hospital outcomes when the subject is diagnosed with sepsis. Sepsis is defined as either the presence of pathogenic organisms or their toxins in the blood and tissues. Sepsis is one of the most significant challenges in critical care medicine. The investigators propose that hypoxia-induced expression of HIF-1 alpha will correlate with the clinical features of Sepsis and in the future, HIF-1 alpha may be used as a biomarker in Sepsis.

NCT ID: NCT02150512 Recruiting - Septic Shock Clinical Trials

Resuscitation Strategies in Septic Shock

ReSSeS
Start date: November 2014
Phase: N/A
Study type: Interventional

The purpose of this study, in mechanically ventilated septic shock patients, is to determine whether a fluid loading strategy based on parameters derived from the transpulmonary thermodilution technique may lead to more ventilator free days compared to a fluid loading strategy based on the surviving sepsis guidelines.

NCT ID: NCT02135796 Recruiting - Septic Shock Clinical Trials

Echocardiography in Septic Shock

Start date: October 2008
Phase:
Study type: Observational

BACKGROUND: Echocardiography can provide evaluation of right or left ventricular dysfunction and volume status during resuscitation of patients with sepsis and septic shock and guide intravenous vasopressor and fluid therapy. While there are numerous echocardiographic studies regarding cardiac function and volume status in patients with established shock, there are none that describe these during the early resuscitation of septic shock. The study objective is to correlate echocardiographic findings with clinical parameters and net fluid balance measured during the early resuscitation of critically ill patients with sepsis and septic shock. Aim 1) correlate echocardiographic findings of cardiac function with physiologic markers in the early hours of resuscitation Aim 2) correlate cardiac function and fluid status with clinical outcomes Aim 3) evaluate the change in cardiac function over time in patients with sepsis and septic shock Aim 4) evaluate long term clinical outcomes for patients with sepsis and septic shock.

NCT ID: NCT02135770 Completed - Clinical trials for Severe Sepsis With Septic Shock

Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis

Start date: January 2013
Phase: Phase 3
Study type: Interventional

Sepsis is a clinical syndrome which infection trigger systemic inflammatory response. Uncontrolled inflammatory process leads to multiple organ dysfunction and cause early mortality in severe sepsis. Unfractionated heparin is an anticoagulant that widely used either for DVT prophylaxis or treatment of disseminated intravascular coagulation. Heparin also have an anti-inflammatory effect through downregulates nuclear factor kappa B and tumor necrosis factor alpha. Aim of this study is to determine effects of low dose unfractionated heparin treatment on inflammation in severe sepsis patient.

NCT ID: NCT02120404 Active, not recruiting - Septic Shock Clinical Trials

Pilot Phase II Study: Hemodynamic Tolerance and Anti-inflammatory Effects of Esmolol During the Treatment of Septic Shock

THANE
Start date: April 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is : - to evaluate the hemodynamic tolerance of esmolol titrated to obtain a lowering of heart rate of 10% or 20%.