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25 Mechanisms of Action

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|||||||||| Trial completion: Investigating FE 202158 as Potential Primary Treatment in Patients With Early Septic Shock (clinicaltrials.gov) - Feb 25, 2014
P2, N=31, Completed, Sponsor: Ferring Pharmaceuticals
Active, not recruiting --> Completed

||||||||||  fludrocortisone / Generic mfg.
New P3 trial:  Effects of Fludrocortisone on Norepinephrine-mean Arterial Pressure Dose-response in Septic Shock (clinicaltrials.gov) -  Feb 20, 2014
P3, N=0, Withdrawn,  Sponsor: Rennes University Hospital

|||||||||| Trial completion: ATHOS: Intravenous AII for the Treatment of Severe Hypotension in High Output Shock: A Pilot Study (clinicaltrials.gov) - Feb 17, 2014
P1, N=20, Completed, Sponsor: George Washington University
Active, not recruiting --> Completed Recruiting --> Completed

|||||||||| Biomarker, Enrollment open: Neutrophil Gelatinase Associated Lipocalin (NGAL) in Urine: Can This Prove to be a Biomarker for Acute Kidney Injury in Patients With Sepsis? (clinicaltrials.gov) - Jan 31, 2014
P=N/A, N=40, Recruiting, Sponsor: Sygehus Lillebaelt
Recruiting --> Completed Not yet recruiting --> Recruiting

||||||||||  midazolam hydrochloride / Generic mfg.
New P1/2 trial:  The Effect of Midazolam on Fluid Responsiveness in Septic Patients (clinicaltrials.gov) -  Jan 29, 2014
P1/2, N=40, Completed,  Sponsor: Southeast University, China

||||||||||  midazolam hydrochloride / Generic mfg.
Trial completion:  The Effect of Midazolam on Fluid Responsiveness in Septic Patients (clinicaltrials.gov) -  Jan 29, 2014
P1/2, N=40, Completed,  Sponsor: Southeast University, China
Not yet recruiting --> Recruiting Not yet recruiting --> Completed

||||||||||  Fragmin (dalteparin sodium) / Pfizer, Eisai
Enrollment closed:  Heparin Anticoagulation to Improve Outcomes in Septic Shock: The HALO Pilot (clinicaltrials.gov) -  Jan 16, 2014
P2, N=76, Active, not recruiting,  Sponsor: University of Manitoba
Not yet recruiting --> Completed Recruiting --> Active, not recruiting

|||||||||| Enrollment open: Pilot Study for the SQUEEZE Trial (clinicaltrials.gov) - Jan 5, 2014
P3, N=50, Recruiting, Sponsor: McMaster Children's Hospital
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting

|||||||||| New P2/3 trial: Efficacy of Mw Vaccine in Treatment of Severe Sepsis (clinicaltrials.gov) - Dec 30, 2013
P2/3, N=50, Completed, Sponsor: Postgraduate Institute of Medical Education and Research

|||||||||| Enrollment closed: TRISS: Transfusion-requirements in Septic Shock Trial (clinicaltrials.gov) - Dec 26, 2013
P3, N=1000, Active, not recruiting, Sponsor: Scandinavian Critical Care Trials Group
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting

|||||||||| Trial completion: ABDO-MIX: Effects of Hemoperfusion With a Polymyxin B Membrane in Peritonitis With Septic Shock (clinicaltrials.gov) - Dec 16, 2013
P3, N=243, Completed, Sponsor: Meditor SAS
Recruiting --> Active, not recruiting Active, not recruiting --> Completed

|||||||||| Enrollment open, Monotherapy, Head-to-Head: Efficacy and Safety of Monotherapy With Noradrenaline and Terlipressin in Patients of Cirrhosis With Septic Shock Admitted to Intensive Care Unit (clinicaltrials.gov) - Dec 15, 2013
P=N/A, N=84, Recruiting, Sponsor: Institute of Liver and Biliary Sciences, India
Active, not recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| Enrollment change: Septic Shock and Delirium Because of rSO2 Abnormalities in Intensive Care Unit Patients (The SAD BRAIN Study) (clinicaltrials.gov) - Dec 5, 2013
P=N/A, N=16, Completed, Sponsor: University of Manitoba
Not yet recruiting --> Recruiting N=20 --> 16

|||||||||| Trial completion: Septic Shock and Delirium Because of rSO2 Abnormalities in Intensive Care Unit Patients (The SAD BRAIN Study) (clinicaltrials.gov) - Dec 5, 2013
P=N/A, N=16, Completed, Sponsor: University of Manitoba
N=20 --> 16 Recruiting --> Completed

||||||||||  ceftriaxone / Generic mfg.
Clinical:  PHANTASi: Prehospital Antibiotics Against Sepsis Trial (clinicaltrials.gov) -  Nov 18, 2013
P=N/A, N=2200, Not yet recruiting,  Sponsor: VU University Medical Center

|||||||||| Trial completion: SEPSICOAG: Prospective Validation of Clini-biological Parameters Including Initial Hemostasis, Which Improve the Prediction of Death at 1 Month Among Patients With Septic Shock (clinicaltrials.gov) - Nov 14, 2013
P=N/A, N=780, Completed, Sponsor: Centre Hospitalier Universitaire de Nīmes
Recruiting --> Completed Recruiting --> Completed

|||||||||| Enrollment open: International Multicentre Prevalence Study on Sepsis (clinicaltrials.gov) - Nov 13, 2013
P=N/A, N=1000, Recruiting, Sponsor: European Society of Intensive Care Medicine
Recruiting --> Completed Not yet recruiting --> Recruiting

||||||||||  piperacillin sodium/tazobactam sodium / Generic mfg., doripenem / Generic mfg.
Enrollment change:  Pharmacokinetic of Doripenem and Piperacillin/Tazobactam in More Than 120 kg Critically Ill Patients (clinicaltrials.gov) -  Nov 4, 2013
P=N/A, N=50, Completed,  Sponsor: University Hospital, Montpellier
Not yet recruiting --> Recruiting N=40 --> 50

||||||||||  piperacillin sodium/tazobactam sodium / Generic mfg., doripenem / Generic mfg.
Trial completion:  Pharmacokinetic of Doripenem and Piperacillin/Tazobactam in More Than 120 kg Critically Ill Patients (clinicaltrials.gov) -  Nov 4, 2013
P=N/A, N=50, Completed,  Sponsor: University Hospital, Montpellier
N=40 --> 50 Recruiting --> Completed

||||||||||  clonidine / Generic mfg.
Trial initiation date:  CATACHOC: Upregulation of Alpha-1 Receptors Upon Septic Shock? (clinicaltrials.gov) -  Nov 3, 2013
P2/3, N=40, Recruiting,  Sponsor: Direction Centrale du Service de Santé des Armées
Recruiting --> Completed Initiation date: Apr 2013 --> Aug 2013

|||||||||| Enrollment open: HEMOSEPSIS: Transpulmonary Thermodilution and Transesophageal Echocardiography in Early Septic Shock (clinicaltrials.gov) - Oct 30, 2013
P3, N=153, Recruiting, Sponsor: University Hospital, Limoges
Initiation date: Apr 2013 --> Aug 2013 Not yet recruiting --> Recruiting

|||||||||| New P3 trial: Pilot Study for the SQUEEZE Trial (clinicaltrials.gov) - Oct 30, 2013
P3, N=50, Recruiting, Sponsor: McMaster Children's Hospital

|||||||||| Trial completion: Early Haemodynamic Optimization Using Preload Dependence During Septic Shock = EHOSS-1 (clinicaltrials.gov) - Oct 29, 2013
P=N/A, N=61, Completed, Sponsor: Hospices Civils de Lyon
Not yet recruiting --> Recruiting Not yet recruiting --> Completed

|||||||||| Enrollment closed: IMproved PREdiction of Severe Sepsis in the Emergency Department (clinicaltrials.gov) - Oct 24, 2013
P=N/A, N=1000, Active, not recruiting, Sponsor: Axis Shield Diagnostics Ltd
Not yet recruiting --> Completed Recruiting --> Active, not recruiting

|||||||||| Trial initiation date: Lactated Ringer Versus Albumin in Early Sepsis Therapy (clinicaltrials.gov) - Oct 15, 2013
P3, N=360, Recruiting, Sponsor: University of Sao Paulo
Recruiting --> Active, not recruiting Initiation date: Jan 2013 --> Oct 2013

|||||||||| Enrollment open: Lactated Ringer Versus Albumin in Early Sepsis Therapy (clinicaltrials.gov) - Oct 15, 2013
P3, N=360, Recruiting, Sponsor: University of Sao Paulo
Initiation date: Jan 2013 --> Oct 2013 Not yet recruiting --> Recruiting

||||||||||  simvastatin / Generic mfg.
Enrollment open:  Statin Therapy in the Treatment of Sepsis (clinicaltrials.gov) -  Oct 7, 2013
P2/3, N=60, Recruiting,  Sponsor: Beth Israel Deaconess Medical Center
Not yet recruiting --> Recruiting Active, not recruiting --> Recruiting

|||||||||| Clinical: Investigate the Activity of Endotoxin in Severe Sepsis (clinicaltrials.gov) - Oct 6, 2013
P=N/A, N=60, Recruiting, Sponsor: National Taiwan University Hospital

||||||||||  hydrocortisone / Generic mfg.
Trial completion:  HYPRESS: Hydrocortisone for Prevention of Septic Shock (clinicaltrials.gov) -  Sep 25, 2013
P3, N=380, Completed,  Sponsor: Charite University, Berlin, Germany
Active, not recruiting --> Recruiting Recruiting --> Completed

|||||||||| Trial completion: Skeletal Muscle and Platelet Mitochondrial Dysfunction During Sepsis (clinicaltrials.gov) - Sep 25, 2013
P=N/A, N=50, Completed, Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Recruiting --> Completed Recruiting --> Completed

|||||||||| Clinical: Venous Lactate in Progression to Overt Septic Shock and Mortality in Non-elderly Sepsis Patients in Emergency Department (clinicaltrials.gov) - Sep 18, 2013
P=N/A, N=400, Recruiting, Sponsor: Chulalongkorn University

|||||||||| Enrollment open: German Lactat Clearance in Severe Sepsis (clinicaltrials.gov) - Aug 20, 2013
P=N/A, N=300, Recruiting, Sponsor: RWTH Aachen University
Recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| Enrollment open, Review: Outcomes of Severe Sepsis Patients in Surgical Intensive Care Units (clinicaltrials.gov) - Aug 6, 2013
P=N/A, N=1100, Recruiting, Sponsor: National Taiwan University Hospital
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting

|||||||||| Enrollment change: Procalcitonin Monitoring Sepsis Study (clinicaltrials.gov) - Jul 24, 2013
P=N/A, N=800, Recruiting, Sponsor: Brahms AG
Not yet recruiting --> Recruiting N=360 --> 800

|||||||||| Trial completion: A Study to Compare the Efficacy and Safety of 2 Dosing Regimens of IV Infusions of AZD9773 (CytoFab™) With Placebo in Adult Patients With Severe Sepsis and/or Septic Shock (clinicaltrials.gov) - Jul 18, 2013
P2b, N=300, Completed, Sponsor: AstraZeneca
N=360 --> 800 Active, not recruiting --> Completed

|||||||||| Trial completion: SISPCT: Placebo Controlled Trial of Sodium Selenite and Procalcitonin Guided Antimicrobial Therapy in Severe Sepsis (clinicaltrials.gov) - Jun 27, 2013
P3, N=1180, Completed, Sponsor: Kompetenznetz Sepsis
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Inomax (nitric oxide) / Mallinckrodt
Enrollment change:  Randomized Trial of Inhaled Nitric Oxide to Augment Tissue Perfusion in Sepsis (clinicaltrials.gov) -  Jun 2, 2013
P3, N=49, Completed,  Sponsor: National Institute of General Medical Sciences (NIGMS)
Active, not recruiting --> Completed N=138 --> 49

||||||||||  Inomax (nitric oxide) / Mallinckrodt
Trial completion:  Randomized Trial of Inhaled Nitric Oxide to Augment Tissue Perfusion in Sepsis (clinicaltrials.gov) -  Jun 2, 2013
P3, N=49, Completed,  Sponsor: National Institute of General Medical Sciences (NIGMS)
N=138 --> 49 Recruiting --> Completed

||||||||||  Byetta (exenatide) / AstraZeneca
Trial withdrawal:  Pharmacology of Exenatide in Pediatric Sepsis (clinicaltrials.gov) -  May 23, 2013
P1/2, N=0, Withdrawn,  Sponsor: Seattle Children's Hospital
Recruiting --> Completed Not yet recruiting --> Withdrawn

||||||||||  Byetta (exenatide) / AstraZeneca
Enrollment change:  Pharmacology of Exenatide in Pediatric Sepsis (clinicaltrials.gov) -  May 23, 2013
P1/2, N=0, Withdrawn,  Sponsor: Seattle Children's Hospital
Not yet recruiting --> Withdrawn N=100 --> 0

||||||||||  clonidine / Generic mfg.
New P2/3 trial:  CATACHOC: Upregulation of Alpha-1 Receptors Upon Septic Shock? (clinicaltrials.gov) -  May 15, 2013
P2/3, N=40, Recruiting,  Sponsor: Direction Centrale du Service de Santé des Armées

|||||||||| Trial termination: GCIV as an Adjuvant Therapy for Community-Acquired Severe Sepsis or Septic Shock (clinicaltrials.gov) - Apr 28, 2013
P3, N=214, Terminated, Sponsor: Green Cross Corporation
N=100 --> 0 Suspended --> Terminated

|||||||||| Trial completion: Evaluation of Hemodynamic Effects of Cascade Hemofiltration in Septic Shock (clinicaltrials.gov) - Apr 8, 2013
P3, N=60, Completed, Sponsor: Gambro Lundia AB
Suspended --> Terminated Active, not recruiting --> Completed

|||||||||| Enrollment change: EARTH-ICU: Early Physical Therapy in Patients With Sepsis (clinicaltrials.gov) - Feb 24, 2013
P=N/A, N=36, Recruiting, Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Active, not recruiting --> Completed N=22 --> 36

|||||||||| Enrollment open: EARTH-ICU: Early Physical Therapy in Patients With Sepsis (clinicaltrials.gov) - Feb 24, 2013
P=N/A, N=36, Recruiting, Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
N=22 --> 36 Not yet recruiting --> Recruiting

|||||||||| Trial completion: Diagnostic and Prognostic Value of Serial Procalcitonin (PCT) Measurements in Critically Ill Patients (clinicaltrials.gov) - Feb 14, 2013
P=N/A, N=300, Completed, Sponsor: The Cleveland Clinic
Not yet recruiting --> Recruiting Active, not recruiting --> Completed

||||||||||  esmolol / Generic mfg.
Enrollment change:  Heart Rate Control With Esmolol in Septic Shock (clinicaltrials.gov) -  Jan 22, 2013
P2, N=154, Completed,  Sponsor: Andrea Morelli
Active, not recruiting --> Completed N=100 --> 154

||||||||||  esmolol / Generic mfg.
Trial completion:  Heart Rate Control With Esmolol in Septic Shock (clinicaltrials.gov) -  Jan 22, 2013
P2, N=154, Completed,  Sponsor: Andrea Morelli
N=100 --> 154 Recruiting --> Completed

|||||||||| Clinical: Dose-response Study of Arginine Supplementation in Severe Sepsis (clinicaltrials.gov) - Jan 22, 2013
P0, N=8, Completed, Sponsor: Maastricht University Medical Center

||||||||||  eritoran (E5564) / Eisai
Trial completion:  ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis (clinicaltrials.gov) -  Jan 1, 2013
P3, N=2000, Completed,  Sponsor: Eisai Inc.
Recruiting --> Completed Active, not recruiting --> Completed