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Septic Shock clinical trials

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NCT ID: NCT02668432 Terminated - Septic Shock Clinical Trials

Use of Amiodarone in Atrial Fibrillation Associated With Severe Sepsis or Septic Shock

Start date: May 2016
Phase: Phase 4
Study type: Interventional

Purpose/Objectives: Severe sepsis and septic shock are a common cause of new onset atrial fibrillation (NOAF) in the intensive care unit. Development of NOAF in this setting can prolong length of stay and increase mortality. Amiodarone is the most commonly used agent used in this setting to control rate and rhythm. However, limited data exist detailing appropriate dosing in this setting. The primary objective of this study is to evaluate two amiodarone dosing strategies, a full loading dose versus a partial loading dose, in patients with new-onset atrial fibrillation (AF) due to severe sepsis or septic shock to assess the mean heart rate every 6 hours after initiation of amiodarone infusion to day 7 or death. Research Design/Plan: Consecutive patients admitted to the medical or cardiac intensive care unit at University Hospital with NOAF in the setting of severe sepsis or septic shock will be screened for study inclusion. Data will be collected and stored using Microsoft Excel or Access and analyzed with JMP 12.0 and SPSS. Methods: Patients aged 18 years or older who develop new-onset atrial fibrillation in the setting of severe sepsis or septic shock and in whom the medical team deems appropriate to initiate amiodarone therapy in will be considered for study inclusion. Patients will receive intravenous (IV) and oral (PO) amiodarone, as per the standard of care. Patients will be randomized to a certain quantitative loading dose strategy; either a full loading dose (≥ 5g IV or ≥10g PO +/- 20%) or a partial loading dose (<4g IV or < 8g PO). Clinical Relevance: With intensive care unit length of stay (ICU LOS) and mortality being twice as high in NOAF with sepsis as compared to septic patients without NOAF, the investigators ultimately aim to identify a management strategy that may minimize this morbidity and mortality while also minimizing exposure to a drug that may cause serious adverse effects.

NCT ID: NCT02576457 Terminated - Septic Shock Clinical Trials

Safety, Pharmacokinetics and Pharmacodynamics of BMS-936559 in Severe Sepsis

Start date: December 2, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether BMS-936559 is safe and has the desired pharmacologic activity in patients who have severe sepsis.

NCT ID: NCT02508649 Terminated - Septic Shock Clinical Trials

Selepressin Evaluation Programme for Sepsis-Induced Shock - Adaptive Clinical Trial

SEPSIS-ACT
Start date: July 2015
Phase: Phase 2/Phase 3
Study type: Interventional

This is a double-blind, randomised, placebo-controlled, two-part adaptive clinical trial. The trial is designed to investigate the efficacy and safety of multiple dosing regimens of selepressin and to confirm the efficacy and safety of one dosing regimen in treatment of adult patients with septic shock requiring vasopressor.

NCT ID: NCT02369900 Terminated - Septic Shock Clinical Trials

Esmolol to Treat the Hemodynamic Effects of Septic Shock

Start date: March 2015
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to determine the effects of controlling the heart rate of patients with septic shock using an intravenous medication called esmolol.

NCT ID: NCT02357433 Terminated - Septic Shock Clinical Trials

Mortality Reduction in Septic Shock by Plasma Adsorption

ROMPA
Start date: February 2015
Phase: N/A
Study type: Interventional

The study objective is to clarify whether the application of high doses CPFA (Coupled Plasma-Filtration Adsorption) in addition to the current clinical practice is able to reduce hospital mortality in septic shock patients in intensive care unit (ICU).

NCT ID: NCT02335723 Terminated - Septic Shock Clinical Trials

ASSET - a Double-Blind, Randomized Placebo-Controlled Clinical Investigation With Alteco® LPS Adsorber

ASSET
Start date: September 2015
Phase: N/A
Study type: Interventional

The primary objective of this clinical investigation is to investigate the feasibility and possible benefits of the Alteco® LPS Adsorber in treating patients with septic shock with presumed endotoxemia of abdominal or urogenital origin.

NCT ID: NCT02317549 Terminated - Septic Shock Clinical Trials

Treatment of Septic Shock by Inhibiting Autodigestion and Preserving Gut Integrity With Enteric LB1148

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

Septic shock is a potentially life-threatening condition that can result in multi-organ dysfunction syndrome (MODS) and mortality. LB1148 was formulated to preserve gut integrity during physiological shock and ameliorate the subsequent autodigestion leading to MODS and mortality. The purpose of this study in septic shock patients is to determine if enteral administration of LB1148 will increase the number of days alive without cardiovascular, pulmonary or renal replacement therapy through Day 28.

NCT ID: NCT02237833 Terminated - Septic Shock Clinical Trials

Cerebral Oxygenation in Septic Patients Using Vasopressors - the Conscious Study

CONSCIOUS
Start date: February 2015
Phase: N/A
Study type: Observational

The purpose of this study is to reveal if higher doses of vasopressors in septic shock patients correlates with cerebral vasoconstriction and lower cerebral oximetry.

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: NCT01957254 Terminated - Septic Shock Clinical Trials

Investigate the Activity of Endotoxin in Severe Sepsis

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

Endotoxin is the major mediator of gram-negative bacteria which cause the systemic inflammation and result in microcirculatory dysfunction, and it leads to multiple organ dysfunction and death in patients with severe sepsis and septic shock. The goal of this study is to measure the endotoxin activity of patients with severe sepsis and septic shock at certain time points, and furthermore, to compare the difference of endotoxin activity among different pathogens, infection source, and antibiotics. The study will enroll severe sepsis and septic shock patients. The endotoxin activity will be measured at certain time points according to the protocol.