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

NCT03092245 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2023-01-19

No results posted yet for this study

Summary

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

Conditions

  • Septic Shock

Interventions

DRUG

OctaplasLG

OctaplasLG is given as an infusion when resuscitation fluids are required.

DRUG

Ringer-Acetate

Ringer-acetate is given as an infusion when resuscitation fluids are required.

Sponsors & Collaborators

  • Octapharma

    collaborator INDUSTRY

  • University of Iceland

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Niels E Clausen · Bispebjerg and Frederiksberg Hospitals, Capitol Region of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-18
Primary Completion
2019-04-17
Completion
2019-04-17

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03092245 on ClinicalTrials.gov