Clinical trials: Sepsis and Septic Shock
Sepsis, Septic Shock
Hemodynamic and Perfusion Response to Drotrecogin Alfa (Activated) in Patients With Septic Shock
The study will evaluate the vasopressor requirement, hemodynamic response and measures of tissue perfusion in patients with septic shock receiving an infusion of drotrecogin alfa (activated) compared to patients not receiving…
- Trial name
- NCT00279214
- Testing
- drotrecogin alfa (activated)
- Where
- 2 sites in United States
- Volunteers
- 43 people
- Sponsor
- Eli Lilly and Company
Sepsis, Severe Sepsis
Protocolized Care for Early Septic Shock
The ProCESS study is large, 5-year, multicenter study of alternative resuscitation strategies for septic shock. The study hypothesizes that there are "golden hours" in the initial management of septic shock where prompt…
- Conditions
- Sepsis, Severe Sepsis, Septic Shock
- Trial name
- ProCESS (NCT00510835)
- Testing
- Early Goal Directed Therapy (EGDT), Protocolized Standard Care (PSC), Usual Care (UC)
- Where
- 31 sites in United States
- Volunteers
- 1,351 people
- Sponsor
- University of Pittsburgh
Sepsis
A Randomized Controlled Trial of a Conservative Fluid Balance Strategy for Patients With Sepsis and Cardiopulmonary Dysfunction (BALANCE Study)
Sepsis is a common inflammatory response to infection characterized by hypovolemia and vasodilation for which early administration of intravenous fluids has been suggested to improve outcomes.
- Trial name
- BALANCE (NCT02159079)
- Testing
- Conservative Fluid Management Strategy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Vanderbilt University
Severe Sepsis, Septic Shock
A Study to Assess Safety,and Tolerability of 2 Doses of AZD9773 (CytoFab™) in Japanese With Severe Sepsis/Septic Shock
The two co-primary objectives of this study are to assess in Japanese patients with severe sepsis and/or septic shock: 1) the safety and tolerability of two different doses of intravenous AZD9773 and 2) the PK of AZD9773.
- Trial name
- NCT01144624
- Testing
- AZD9773
- Where
- 7 sites in Japan
- Volunteers
- 20 people
- Sponsor
- AstraZeneca
Septic Shock, Endotoxemia
Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock
To compare the safety and efficacy of the PMX cartridge based on mortality at 28-days in subjects with septic shock who have high levels of endotoxin and are treated with standard medical care plus use of the PMX cartridge…
- Trial name
- EUPHRATES (NCT01046669)
- Testing
- TORAYMYXIN PMX-20R (PMX cartridge), Standard medical care for septic shock
- Where
- 40 sites in United States, Canada
- Volunteers
- 450 people
- Sponsor
- Spectral Diagnostics (US) Inc.
Sepsis
Randomized Trial of Inhaled Nitric Oxide to Augment Tissue Perfusion in Sepsis
The purpose of this study is to determine whether inhaled nitric oxide is an effective treatment for microcirculatory dysfunction and acute organ system failure in the early stage of sepsis therapy.
- Trial name
- NCT00608322
- Testing
- Inhaled nitric oxide
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- National Institute of General Medical Sciences (NIGMS)
Shock, Septic
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM (Nangibotide) in Patients With Septic Shock
This is a randomised, double-blind, two-stage, placebo controlled study. It is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of nangibotide versus placebo in adult patients…
- Trial name
- NCT03158948
- Testing
- Nangibotide 0.3 mg/kg, Nangibotide 1 mg/kg, Nangibotide 3 mg/kg
- Where
- 4 sites in Belgium, France and 2 more
- Volunteers
- 50 people
- Sponsor
- Inotrem
Sepsis, Severe, Septic Shock
Metabolic Resuscitation Using Ascorbic Acid, Thiamine, and Glucocorticoids in Sepsis.
This study has been created to compare the addition of intravenous (IV) vitamin C, thiamine, and hydrocortisone to the usual standard of care of sepsis and septic shock.
- Trial name
- ORANGES (NCT03422159)
- Testing
- Ascorbic Acid, Thiamine, Hydrocortisone
- Where
- 2 sites in United States
- Volunteers
- 140 people
- Sponsor
- Community Medical Center, Toms River, NJ
Escalation of Care, Cardiopulmonary Arrest
Early Warning System for Clinical Deterioration on General Hospital Wards
The goal is to develop a two-tiered monitoring system to improve the care of patients at risk for clinical deterioration on general hospital wards (GHWs) at Barnes-Jewish Hospital (BJH).
- Conditions
- Escalation of Care, Cardiopulmonary Arrest, Respiratory Arrest, Severe Sepsis
- Trial name
- NCT01280942
- Testing
- EWS Nursing Alerts, Wireless Remote Sensor
- Where
- United States
- Volunteers
- 20,031 people
- Sponsor
- Washington University School of Medicine
Sepsis, Hypotension
Fluid Responsiveness Evaluation in Sepsis-associated Hypotension
This study assesses the mean difference in fluid balance at ICU discharge and associated patient outcomes, based on a dynamic assessment of fluid responsiveness in septic patients with refractory hypotension in an ICU setting.
- Trial name
- FRESH (NCT02837731)
- Testing
- Treatment Starling SV monitor
- Where
- 12 sites in United States, United Kingdom
- Volunteers
- 150 people
- Sponsor
- Cheetah Medical Inc.
Septic Shock
HCT+F vs. HCT Alone in Critically Ill Medical Septic Shock Patients
This study will be conducted as a single-center, prospective, open-label, randomized trial that will evaluate adult patients admitted with septic shock to the medical critical care unit (MCC).
- Trial name
- NCT03710187
- Testing
- Hydrocortisone
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- University of Tennessee Medical Center
Toxic-Shock Syndrome, Sepsis
Amendment of rTSST-1 Variant Vaccine Phase 1 Clinical Trial
Toxic Shock Syndrome (TSS) a severe condition with high morbidity and mortality results from the hosts overwhelming inflammatory response and cytokine storm. Staphylococcal superantigen toxins are the main causative agents.
- Trial name
- NCT02971670
- Testing
- rTSST-1 Variant Candidate Vaccine
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Biomedizinische Forschungs gmbH
Shock, Septic
Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis: A Pilot Feasibility Study
The objective of this pilot study is to assess overall feasibility prior to embarking on a larger randomized pragmatic trial comparing the clinical effectiveness of fluid resuscitation with NS versus LR for pediatric patients…
- Trial name
- PRoMPT BOLUS (NCT03340805)
- Testing
- Lactated Ringer, Normal saline
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Children's Hospital of Philadelphia
Septic Shock
Effects of the V1a Agonist FE 202158 in Patients With Septic Shock
The purpose of this trial was to examine the safety and tolerability, pharmacokinetics of FE 202158 and to assess whether it can stabilize blood pressure and reduce vascular (blood vessel) leakage.
- Trial name
- NCT01000649
- Testing
- FE 202158 1.25, FE 202158 2.5, FE 202158 3.75
- Where
- 16 sites in United States, Belgium and 2 more
- Volunteers
- 53 people
- Sponsor
- Ferring Pharmaceuticals
Severe Sepsis
A Study of Nivolumab Safety and Pharmacokinetics in Patients With Severe Sepsis or Septic Shock.
A study to evaluate the safety, tolerability and pharmacokinetics of Nivolumab in participants with severe sepsis or septic shock.
- Trial name
- NCT02960854
- Testing
- Nivolumab
- Where
- 16 sites in United States
- Volunteers
- 38 people
- Sponsor
- Bristol-Myers Squibb
Septic Shock
Thiamine as a Metabolic Resuscitator in Septic Shock
The major goal of this project is to determine whether the use of thiamine in patients with septic shock will result in attenuation of lactic acidosis and a more rapid reversal of shock.
- Trial name
- NCT01070810
- Testing
- D5W, Thiamine
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- Beth Israel Deaconess Medical Center
Sepsis, Septic Shock
Release of Nociceptin From Granulocytes in Sepsis
Nociceptin is a protein found in the body, with a number of functions in the central nervous system, blood vessels and the gut. There is evidence that it may have a role in controlling the immune response to infection, and may…
- Conditions
- Sepsis, Septic Shock, Sepsis Syndrome, Severe Sepsis
- Trial name
- NCT03037281
- Testing
- Septic
- Where
- 2 sites in United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of Leicester
Sepsis, Septic Shock
Ascorbic Acid (Vitamin C) Infusion in Human Sepsis
The major goal of this project is to determine whether intravenously infused ascorbic acid is safe for use as a viable therapeutic strategy in adult humans with sepsis.
- Conditions
- Sepsis, Septic Shock, Hypotension, Acute Lung Injury
- Trial name
- NCT01434121
- Testing
- Ascorbic Acid
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Virginia Commonwealth University
Sepsis, Severe Sepsis
Preemptive Resuscitation for Eradication of Septic Shock
The purpose of this study is to assess the ability of an empiric resuscitation strategy compared to standard care to decrease the incidence of organ failure in normotensive sepsis patients.
- Trial name
- NCT01449721
- Testing
- Intravenous fluid
- Where
- 5 sites in United States
- Volunteers
- 142 people
- Sponsor
- Christiana Care Health Services
Septic Shock
Hemodynamic and Inflammatory Effects of Abrupt Versus Tapered Corticosteroid Discontinuation in Septic Shock
The proposed study will evaluate the potential benefit of a tapered course of hydrocortisone compared to abrupt cessation in patients initiated on hydrocortisone for septic shock.
- Trial name
- NCT01150409
- Testing
- hydrocortisone, Normal Saline
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- The Cleveland Clinic