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Severe Sepsis clinical trials

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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: NCT02569086 Completed - Sepsis Clinical Trials

Piperacillin PK Analysis in Severe Sepsis Patients

Start date: November 1, 2015
Phase: N/A
Study type: Observational

Antibiotic dosing in septic patients poses a challenge for clinicians due to the pharmacokinetic changes seen in this population. Piperacillin/tazobactam is often used for empirical treatment, and initial appropriate dosing is crucial for reducing mortality. The investigators aim was to determined the pharmacokinetic profile of piperacillin 4g every 8 hour in 22 patients treated empirically for sepsis and severe sepsis. A PK population model was be established with the dual purpose to assess current standard treatment and to simulate alternative dosing regimens and modes of administration. Time above the minimal inhibitory concentration (T>MIC) predicted for each patient was evaluated against clinical breakpoint MIC for Pseudomonas Aeruginosa (16 mg/L). Pharmacokinetic-pharmacodynamic (PK-PD) targets evaluated were 100% f T>MIC and 50% fT>MIC.

NCT ID: NCT02539147 Completed - Severe Sepsis Clinical Trials

Characterization of Non-canonical Way in Inflammasome Monocytes of Patients With Severe Sepsis

CASPASEs
Start date: September 2014
Phase: N/A
Study type: Observational

Activation of caspase-4 and human caspase-5 (orthologs of caspase-11 in mice) in innate immune cells.

NCT ID: NCT02430142 Completed - Sepsis Clinical Trials

Microcirculatory Oxygen Uptake in Sepsis

Start date: April 2015
Phase:
Study type: Observational

Forearm vasoocclusive testing (VOT) will be performed with laser-doppler spectrophotometry system in septic patients on ICU. Microcirculatory oxygen uptake will be checked for prognostic value and for associations with tissue hypoxia markers and high central venus saturations.

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: NCT02413541 Completed - Severe Sepsis Clinical Trials

The Pilot Study of the Efficacy of Polymyxin-B Hemoperfusion in Critically Ill Patients With Severe Sepsis

Start date: January 2015
Phase: N/A
Study type: Interventional

This research project is a study to immunology changes in critically ill patients with severe sepsis by using Endotoxin Activity Assay (EAA) combined with Polymyxin-B Hemoperfusion.

NCT ID: NCT02393781 Completed - Septic Shock Clinical Trials

Adrenomedullin and Outcome in Severe Sepsis and Septic Shock

AdrenOSS
Start date: June 2015
Phase: N/A
Study type: Observational

The aim of this prospective study is to assess the prognostic value of bioactive plasma adrenomedullin (ADM) in 600 patients with severe sepsis or septic shock in an international multicenter study and to validate the findings concerning the association of ADM concentration and the use of vasopressor therapy, organ failure and outcome.

NCT ID: NCT02376842 Completed - Severe Sepsis Clinical Trials

Study of an Electronic Health Record-embedded Severe Sepsis Early Warning Alert

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

The investigators hypothesize that implementing an electronic health record-based early warning system for severe infections (severe sepsis) will decrease the time to antibiotic order. The study will consist of an algorithm which will monitor lab values, vital signs, and nursing documentation for signs of severe sepsis. When these criteria are met, an alert will be delivered via the electronic health record to a nurse and doctor and simultaneously an alert via pager to another nurse. The investigators plan to randomize which patients will generate these alerts and analyze the data after collecting information for approximately 6 months which will be sufficient to detect a 10% difference in the two patient groups.

NCT ID: NCT02370186 Completed - Sepsis Clinical Trials

The Role of Dysfunctional HDL in Severe Sepsis

Start date: February 2015
Phase:
Study type: Observational

Severe sepsis results in over 300,000 Emergency Department (ED) visits and 215,000 deaths annually in the US. Currently there are no effective drug therapies for sepsis. High density lipoprotein (HDL) has antioxidant, anti-inflammatory, and antithrombotic properties and is protective in sepsis. Its functions in sepsis are primarily mediated by its main apolipoprotein, Apo-A1, that: 1) neutralize potent bacterial toxins, 2) protect blood vessel walls from damage, 3) prevent tissue damage through antioxidant properties, and 4) mediate thymocyte apoptosis (critical for survival) and endogenous corticosteroid release. However, recent literature presents inconsistent data on HDL functionality and shows that HDL becomes non-functional during acute inflammatory states called dysfunctional HDL (Dys-HDL). Several causes for Dys-HDL have been hypothesized including the presence of Apo A1 polymorphisms, which may worsen the pathologic inflammatory response in sepsis and have been demonstrated in early sepsis, making Dys-HDL an unstudied potential early marker. This project aims to: 1) determine the presence of Dys-HDL in adult patients with early severe sepsis who present to the ED (Dys-HDL will be tested using a novel cell free assay and HDL Inflammatory Index will be measured), and 2) examine the relationship between Dys-HDL and cumulative organ dysfunction via Sequential Organ Failure Assessment (SOFA) score. Results of this study could establish Dys-HDL as an early disease marker for sepsis which is influential in the development of sepsis-induced organ dysfunction.

NCT ID: NCT02361528 Completed - Septic Shock Clinical Trials

GM-CSF to Decrease ICU Acquired Infections

GRID
Start date: September 14, 2015
Phase: Phase 3
Study type: Interventional

The concept of acquired immunodeficiency after a first severe infection in the ICU is widely described in the literature. There is a dual risk: increased mortality and increased secondary infections. Several approaches of immunostimulatory treatments have been proposed in the literature. The treatment proposed by this study consists of the administration of Granulocyte-macrophage colony-stimulating factor (GM-CSF), colony stimulating factor widely used particularly in the USA where it is marketed. A phase 2 clinical trial was conducted in Germany in 2009. The main objective is to measure the incidence of ICU-acquired infections in 2 groups of patients treated by GM-CSF or placebo. ICU patients at risk are defined as surviving at D3 from a severe sepsis or septic shock and presenting a sepsis associated immunodepression. The detection of immunosuppressed patients will be achieved by measuring the HLA-DR (Human Leucocyte Antigen DR)with a threshold of less to 8000 sites. Our hypothesis is that the number of secondary infections (primary endpoint) will be significantly reduced in the treated group.