Phase 3 N=125 Vitamin C and Septic Shock
Septic Shock · Sepsis
Primary: Number of Participants With ICU Mortality — 20; 14 Participants
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N/A N=142 Preemptive Resuscitation for Eradication of Septic Shock
Sepsis · Severe Sepsis
Primary: Number of Participants With Worsening Organ System Dysfunction Defined by SOFA Score Increase ≥ 1 — 34; 20 Participants — p=0.064
N/A N=15 PK Analysis of Piperacillin in Septic Shock Patients
Septic Shock
Primary: 100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval. — 10 participants
Phase 2 N=88 Thiamine as a Metabolic Resuscitator in Septic Shock
Septic Shock
Primary: Lactate Level 24 Hours After the First Study Medication Dose — 2.6; 2.5 mmol/L — p=0.40
N/A N=450 Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock
Septic Shock · Endotoxemia
Primary: Mortality — 78; 84 Participants
N/A N=458 Venous Lactate in Progression to Overt Septic Shock and Mortality in Non-elderly Sepsis Patients in Emergency Department
Sepsis · Disease Progression · Septic Shock
Primary: Proportion of the Patients Who Require Vasopressor/Mechanical Ventilator — 53; 21 participants
Phase 2 N=120 Vitamin C & Thiamine to Treat Sepsis and Septic Shock
Sepsis · Septic Shock
Primary: Mortality Rates — 12; 7 Participants — p=0.344
Phase 3 N=252 Dopamine Versus Norepinephrine for the Treatment of Vasopressor Dependent Septic Shock
Septic Shock
Primary: Efficacy and Safety of Dopamine Versus Norepinephrine in Septic Shock — 67; 51 participants
Phase 2 N=13 Acetyl-L-Carnitine in the Treatment of Septic Shock
Septic Shock
Primary: Mean Arterial Blood Pressure — 60; 60 mm Hg
N/A N=120 Initiation of Hydrocortisone for the Treatment of Septic Shock
Septic Shock
Primary: 28-day Mortality — 19; 23 Participants
Phase 3 N=1,696 Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock
Sepsis
Primary: 28-Day All-Cause Mortality — 26.4; 24.2 percentage of participants — p=0.313
N/A N=106,629 Effects of Code Sepsis Implementation on Emergency Department (ED) Sepsis Care
Sepsis
Primary: Door-to-antibiotic Time — 160; 146; 139; 140 minutes — p=<0.001
Phase 2 N=250 Rapid Administration of Carnitine in sEpsis
Septic Shock
Primary: Delta SOFA Score — -1.8; -0.34; -1.68; -2.15 units on a scale
Phase 3 N=18 Statin Therapy in the Treatment of Sepsis
Septic Shock
Primary: Time to Shock Reversal — 44.4; 28.6 hours
N/A N=1,351 Protocolized Care for Early Septic Shock
Sepsis · Severe Sepsis · Septic Shock
Primary: Hospital Mortality — 92; 81; 86 Participants
N/A N=19 High MAP in Septic Shock With Hypertension
Septic Shock
Primary: Mean Arterial Pressure — 90 mmHg
Phase 2 N=140 Metabolic Resuscitation Using Ascorbic Acid, Thiamine, and Glucocorticoids in Sepsis.
Sepsis, Severe · Septic Shock
Primary: Time to Vasopressor Independence (Hours) — 27; 53 hours — p=<0.001
Phase 1 N=31 A Study of Nivolumab Safety and Pharmacokinetics in Patients With Severe Sepsis or Septic Shock.
Severe Sepsis
Primary: Percentage of Incidence Rates of Serious Adverse Events (SAEs), Adverse Events (AEs), Immune-mediated AEs, AEs Leading to Discontinuation, and Deaths — 6.7; 43.8; 93.3…
Phase 4 N=28 Renin and Renal Biomarker Response to Angiotensin II
Septic Shock · Acute Kidney Injury
Primary: Change in Plasma Renin Levels — -15; 69; -6; 26 pg/mL
Phase 4 N=43 Hemodynamic and Perfusion Response to Drotrecogin Alfa (Activated) in Patients With Septic Shock
Sepsis · Septic Shock
Primary: Cumulative Vasopressor Index (CVI) — 2.3; 3.0; -2.0; -1.4 units on a scale — p=0.238
Phase 2 N=84 HCT+F vs. HCT Alone in Critically Ill Medical Septic Shock Patients
Septic Shock
Primary: Time to Resolution of Shock — 89; 84 Hours
N/A N=22 Piperacillin PK Analysis in Severe Sepsis Patients
Sepsis · Severe Sepsis
Primary: 100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval. — 4 participants
Phase 4 N=1,554 The Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care Trial
Septic Shock
Primary: 90-day Mortality — 323; 329 Participants
Phase 2 N=31 Investigating FE 202158 as Potential Primary Treatment in Patients With Early Septic Shock
Septic Shock
Primary: Percentage of Patients Maintaining Target/Adequate Mean Arterial Pressure (MAP>60 mmHg) Without Norepinephrine — 20.0; 42.9; 60.0; 7.7 Percentage of patients
N/A N=211 The Randomized Controlled Trial of Inferior Vena Cava Ultrasound-guided Fluid Management in Septic Shock Resuscitation
Septic Shock
Primary: 30-day Mortality — 20; 19 Participants
Phase 2 N=20 A Trial of Vitamin B12 in Septic Shock
Septic Shock
Primary: Feasibility of Clinical and Protocol Completion — 10; 10 Participants
Phase 2 N=301 Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB
Septic Shock
Primary: Endpoints for Primary Objective (Safety and Tolerability of Adrecizumab: Mortality) — 63.1453; 63.1578; 64.5744; 63.9809 days
Phase 2 N=95 Thiamine as a Renal Protective Agent in Septic Shock
Sepsis · Kidney Injury · Thiamine Deficiency
Primary: Kidney Injury Biomarker — 2.24; 2.79 mg/dL — p=0.07
Phase 2 N=12 Pharmacokinetic and Biomarker Study of Pioglitazone in Adolescents With Severe Sepsis and Septic Shock
Severe Sepsis · Septic Shock
Primary: Evaluate the Safety Profile of Pioglitazone in Patients With Severe Sepsis and Septic Shock as the Number of Hypoglycemic Events — 0; 0 events — p=1.0
N/A N=150 Fluid Responsiveness Evaluation in Sepsis-associated Hypotension
Sepsis · Hypotension
Primary: Fluid Balance — 0.65; 2.02 Liters — p=0.021