Septic Shock Clinical Trial
Official title:
A Prospective, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of PMX Cartridge in Addition to Standard Medical Care for Patients With Endotoxemic Septic Shock
Prospective, multicenter, randomized, open-label study of standard of care plus the PMX cartridge versus standard of care alone in patients with endotoxemic septic shock
This is a prospective, multicenter, randomized, open-label trial of standard medical care plus the PMX cartridge versus standard medical care alone, in subjects with endotoxemia and septic shock. Subjects in critical care areas will be assessed for septic shock using known or suspected infection, multiple organ failure, fluid resuscitation and hypotension requiring vasopressor support as primary criteria. Subjects will meet all entry criteria for study if endotoxin activity is within the range of ≥ 0.60 to <0.90. Eligible and consented subjects will be randomized to receive either the PMX cartridge (administered twice for 1½ to 2 hours per treatment session approximately 24 hours apart) plus standard medical care or standard medical care alone. For all randomized subjects, a follow-up visit (if they are still in the hospital) or a telephone call will be completed at Day 28 (or later) to determine their mortality status. In surviving subjects, a follow-up visit or telephone call to determine their mortality status will also take place at approximately three months (i.e. Day 90) and 12 months after the subject was randomized. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03649633 -
Vitamin C, Steroids, and Thiamine, and Cerebral Autoregulation and Functional Outcome in Septic Shock
|
Phase 1/Phase 2 | |
| Terminated |
NCT04117568 -
The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
|
||
| Completed |
NCT04227652 -
Control of Fever in Septic Patients
|
N/A | |
| Completed |
NCT05629780 -
Temporal Changes of Lactate in CLASSIC Patients
|
N/A | |
| Recruiting |
NCT04796636 -
High-dose Intravenous Vitamin C in Patients With Septic Shock
|
Phase 1 | |
| Terminated |
NCT03335124 -
The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock
|
Phase 4 | |
| Recruiting |
NCT04005001 -
Machine Learning Sepsis Alert Notification Using Clinical Data
|
Phase 2 | |
| Recruiting |
NCT05217836 -
Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
|
||
| Recruiting |
NCT05066256 -
LV Diastolic Function vs IVC Diameter Variation as Predictor of Fluid Responsiveness in Shock
|
N/A | |
| Not yet recruiting |
NCT05443854 -
Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)
|
Phase 3 | |
| Not yet recruiting |
NCT04516395 -
Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae
|
N/A | |
| Recruiting |
NCT02899143 -
Short-course Antimicrobial Therapy in Sepsis
|
Phase 2 | |
| Recruiting |
NCT02565251 -
Volemic Resuscitation in Sepsis and Septic Shock
|
N/A | |
| Recruiting |
NCT02676427 -
Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination
|
||
| Recruiting |
NCT02580240 -
Administration of Hydrocortisone for the Treatment of Septic Shock
|
N/A | |
| Completed |
NCT02638545 -
Hemodynamic Effects of Dexmedetomidine in Septic Shock
|
Phase 3 | |
| Not yet recruiting |
NCT02547467 -
TOADS Study: TO Assess Death From Septic Shock.
|
N/A | |
| Terminated |
NCT02335723 -
ASSET - a Double-Blind, Randomized Placebo-Controlled Clinical Investigation With Alteco® LPS Adsorber
|
N/A | |
| Completed |
NCT02204852 -
Co-administration of Iloprost and Eptifibatide in Septic Shock Patients
|
Phase 2 | |
| Completed |
NCT02079402 -
Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care
|
Phase 4 |