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Shock, Septic 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: NCT02424721 Terminated - Sepsis Clinical Trials

Sepsis Assessment in Belgian Emergency Rooms

SABER
Start date: May 2015
Phase:
Study type: Observational

To validate the use of the Heparin Binding Protein (HBP) concentration to assist in the evaluation of patients admitting to the emergency department with suspected infection.

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: NCT02301585 Terminated - Shock, Septic Clinical Trials

Optimization of Fluid Therapy in Sepsis by a Passive Leg Raising Test

OFTaPLR
Start date: February 2014
Phase: N/A
Study type: Interventional

A randomized controlled clinical trial to evaluate whether a passive leg raising test to guide fluid therapy of patients with septic shock can reduce fluid balance and weight gain. Patients will be treated according to an algorithm in which the indexed stroke volume (stroke volume related to body surface area) and mean arterial pressure will guide the timing and amount of fluid and the use of inotropic and vasoactive support. Patients will be randomized to either an intervention group in which a passive leg raising test will be made prior to any decision for fluid administration or to a control group where this test is not performed and fluid administration is carried out according to standard of care at the department. Hypothesis: A passive leg raising test, will reduce weight gain by day 3 by 30%.

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.