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Vasculopathic Injury and Plasma as Endothelial Rescue in Septic Shock (SHOCK) Trial — VIPER-SHOCK  

Septic Shock Clinical Trial

Official title:
Efficacy and Safety of OctaplasLG® Administration vs. Crystalloids (Standard) in Patients With Septic Shock - a Randomized, Controlled, Open-label Investigator-initiated Pilot Trial

Clinical Trial Summary

Efficacy and safety of OctaplasLG® administration vs. crystalloids (standard) in patients with septic shock - a randomized, controlled, open-label investigator-initiated pilot trial

Clinical Trial Description

This is a single center, randomized (1:1, active : standard of care), controlled, open-label, investigator-initiated pilot phase IIa trial in patients with septic shock investigating the efficacy and safety of administrating OctaplasLG® as compared to crystalloids, such as Ringer-Acetate (standard of care) in a total of 40 patients. 40 patients will be enrolled: - Patients in the active treatment group (n = 20 patients) will receive OctaplasLG® as volume support according to trial algorithm. - Patients in the standard of care group (n = 20 patients) will receive crystalloids, such as Ringer-Acetate, as volume support according to trial algorithm. All patients will be treated according to the standard ICU care. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03092245
Study type Interventional
Source Rigshospitalet, Denmark
Contact
Status Completed
Phase Phase 2
Start date April 18, 2017
Completion date April 17, 2019
View Details
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