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Sepsis 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: NCT02602210 Terminated - Liver Cirrhosis Clinical Trials

Supplemental Corticosteroids in Cirrhotic Hypotensive Patients With Suspicion of Sepsis

SCOTCH;
Start date: January 2015
Phase: Phase 3
Study type: Interventional

The main goal of the study is to investigate the clinical relevance, efficacy and safety of treating hypotensive cirrhotic patients with suspicion of sepsis and on vasopressors with low-dose hydrocortisone in order to reverse hemodynamic instability and organ failure and to decrease mortality.

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: NCT02568189 Terminated - Sepsis Clinical Trials

Utility of Ultrasound Assessment of the Inferior Vena Cava in Patients With Sepsis and Dehydration

Start date: October 1, 2015
Phase: N/A
Study type: Interventional

Conduct a randomized, controlled trial looking at how the use of ultrasound analyzing the inferior vena cava impacts the management and outcomes of pediatric emergency department patients undergoing evaluation and treatment of sepsis and gastroenteritis associated dehydration.

NCT ID: NCT02523690 Terminated - Sepsis Clinical Trials

Evaluating Muscle Weakness Improvement With Lorcaserin in ICU

EMILI
Start date: December 2015
Phase: Phase 1/Phase 2
Study type: Interventional

ICU acquired muscle weakness is a significant problem in patients recovering from critical illness. This trial will evaluate the safety and efficacy of a drug in improving muscle weakness in critically ill patients.

NCT ID: NCT02424734 Terminated - Late-onset Sepsis Clinical Trials

Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis

Start date: August 4, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of ceftaroline for the treatment of Late Onset Sepsis in neonates and young infants aged 7 to <60 days

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: NCT02367170 Terminated - Sepsis Clinical Trials

Project 4A: Inspiratory Muscle Training and Diaphragm Strength

Start date: March 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Investigators will assess the effect of exercise on markers of inflammation and protein catabolism. This research study will further our understanding of how treating Chronic Critical illness (CCI) - related respiratory muscle weakness with strength training can not only improve muscle function, but also potentially blunt the inflammation and catabolism of Peristent Inflammation/Immunosuppression and Catabolism (PICS).

NCT ID: NCT02258022 Terminated - Sepsis Clinical Trials

Changes in 13CO2/12CO2 Delta Value in Exhaled Breath as an Early Indicator of Infection in Adult Trauma Subjects

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

Carbon-12 and carbon-13 are naturally-abundant isotopes in exhaled breath carbon dioxide. The ratio of carbon-13 to carbon-12 in exhaled breath is known as the breath delta value. This study is seeking to determine if the breath delta value of adults with trauma is an early indicator of the onset of infection that may lead to sepsis.

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