Vasculopathic Injury and Plasma as Endothelial Rescue in Septic Shock Trial. VIPER-Sepsis (EudraCT no. 2016-000707-81)

NCT02875236 | Terminated Phase 4 DMC

• 1 other identifier: Viper Sepsis
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Microvascular perfusion

  Change in microvascular perfusion as evaluated by sidestream darkfield (SDF; MicroVision Medical, Amsterdam, The Netherlands) imaging technique.

  6 hours after inclusion

• Endothelial activation and damage

  Change in biomarkers indicative of endothelial activation and damage (soluble E-selectin, syndecan-1, thrombomodulin, soluble VE-cadherin, nucleosomes)

  6 hours after inclusion

Secondary Outcomes (8)

• Mortality

  From 6 hours until 90 days

• Length of stay in Intensive Care Unit

  through study completion, an average of 1 month

• Vasopressors

  through study completion, an average of 1 month

• Ventilator

  through study completion, an average of 1 month

• Bleeding

  1 week

Other Outcomes (5)

• SOFA score

  7 days

• AKI

  7 days

• CRRT

  7 days

Study Arms (2)

Control

PLACEBO COMPARATOR

Ringer-acetat

Drug: OctaplasLG®

Intervention

ACTIVE COMPARATOR

OctaplasLG®

Drug: Ringer-acetat

Interventions

OctaplasLG® DRUG

OctaplasLG is an donor plasma product pooled from approximately 1000 single donor units. It possesses unique features when compared to standard fresh frozen plasma, such as having standardized concentrations of natural pro- and anti-coagulation factors, a standardized volume as well as being pathogen free. The manufacturing method of OctaplasLG removes immune complexes and cells in several steps of microfiltration in addition to viral, bacterial and prion pathogen inactivation by immune neutralization. OctaplasLG should reduce the "inflammatory hit" on the endothelium, including the glycocalyx, by having standardized levels of coagulation proteins, which can give more sustainable support to the endothelial regeneration as compared to standard fresh frozen plasma.

Also known as: OctaplasLG

Control

Ringer-acetat DRUG

Crystalloid used as standard of care.

Also known as: Ringer

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult intensive care patients AND
• Septic shock requiring infusion of vasopressor/inotropic agents to maintain blood pressure as defined in international guidelines AND
• Consent obtainable from patient or by proxy (independent physicians and/or next of kin)

You may not qualify if:

• Documented refusal of blood transfusion OR
• Treatment with GPIIb/IIIa inhibitors \< 24h from screening OR
• Withdrawal from active therapy OR
• Previously within 30 days included in a randomised trial, if known at the time of enrolment OR
• Known Immunoglobulin A deficiency with documented antibodies against Immunoglobulin A OR
• Known hypersensitivity to OctaplasLG: the active substance, any of the excipients (Sodium citrate dihydrate, Sodium dihydrogenphosphate dihydrate or Glycine) or residues from the manufacturing process (Tri (N-Butyl) Phosphate (TNBP) and Octoxynol (Triton X-100)) OR
• Known severe deficiencies of protein S OR
• Pregnancy (non-pregnancy confirmed by patient being postmenopausal or having a negative urine-hCG) OR
• Severe cirrhotic hepatic failure with expected need for treatment with terlipressin

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Octapharma: collaborator

Study Sites (1)

Intensive Care Unit Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Per I Johansson, MD

  University of Copenhagen, Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Department of Anesthesia and Intensive Care, Bispebjerg Hospital, Principal Investigator.

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 23, 2016
• Study Start: September 1, 2016
• Primary Completion: November 8, 2016
• Study Completion: November 8, 2016
• Last Updated: January 9, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)