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

NCT03092245 | Completed Phase 2

• 2 other identifiers: VIPER-SHOCK2017-000427-27
• Study Type: interventional
• Target: 44
• 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)

• Microscan at 24 hours

  Change in microvascular perfusion from baseline to 24 hours after inclusion as evaluated by sidestream darkfield (SDF; MicroVision Medical, Amsterdam, The Netherlands) imaging technique.

  24 hours after baseline

• Biomarkers at 24 hours

  Change in biomarkers indicative of endothelial activation and damage (sE-selectin, syndecan-1, thrombomodulin, VEGFR1, VEGF, nucleosomes) from baseline to 24 hours after inclusion.

  24 hours after baseline

Secondary Outcomes (13)

• 24 hour mortality

  24 hours after inclusion

• 7 day mortality

  7 days after inclusion

• 30 day mortality

  30 days after inclusion

• 90 day mortality

  90 days after inclusion

• Length of stay in the ICU

  Days, assessed at 30-days and 90-days

Other Outcomes (8)

• Sepsis-related organ failure assessment (SOFA)

  At 24 hours, 48 hours, 72 hours and at day 7 after baseline

• Thrombelastograph (TEG) maximum amplitude at 24 hours

  At 24 hours after baseline

• Thrombelastograph (TEG) maximum amplitude at 48 hours

  At 48 hours after baseline

Study Arms (2)

OctaplasLG

ACTIVE COMPARATOR

OctaplasLG® is an industrial donor plasma product pooled from 630 -1520 single donor units. It possesses unique features when compared to standard FFP, such as having a standardized concentration of natural pro- and anti-coagulation factors, a standardized volume as well as being pathogen-free.12 Most importantly, the manufacturing method of OctaplasLG® removes immune complexes and cells in several steps of microfiltration. The manufacturing process also inactivates viral, bacterial and prion pathogen by immune neutralization, solvent-detergent treatment and a prion specific ligand affinity chromatography step.

Drug: OctaplasLG

Ringer-Acetate

PLACEBO COMPARATOR

standard of care resuscitation fluid Ringer-acetate is a mixture of electrolytes in water to a slightly hypotonic solution.

Drug: Ringer-Acetate

Interventions

OctaplasLG DRUG

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

Also known as: Octaplas

OctaplasLG

Ringer-Acetate DRUG

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

Also known as: Ringer's Acetate

Ringer-Acetate

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 (age ≥ 18 years) AND
• Sepsis, defined as life-threatening organ dysfunction caused by a dysregulated host response to infection AND
• Quick SOFA (qSOFA) with two or more of
• Respiratory rate ≥ 22/min
• Altered mentation (Glasgow Coma Scale score \< 15)
• Systolic blood pressure ≤ 100mmHg AND
• Septic shock, defined as a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level \>2 mmol/L despite adequate volume resuscitation AND
• Requiring infusion of noradrenalin 0.10 mcg/kg/min or more to maintain blood pressure AND
• Respiratory failure requiring intubation and mechanical ventilation

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 an interventional trial OR
• Known IgA deficiency with documented antibodies against IgA 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
• University of Iceland: collaborator

Study Sites (1)

ICU Bispebjerg Hospital

Copenhagen, 2200, Denmark

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Ringer's acetate

Condition Hierarchy (Ancestors)

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

Study Officials

• Niels E Clausen

  Bispebjerg and Frederiksberg Hospitals, Capitol Region of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaethetist, MD, PhD

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 27, 2017
• Study Start: April 18, 2017
• Primary Completion: April 17, 2019
• Study Completion: April 17, 2019
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)