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

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ClinicalTrials.gov Identifier: NCT03092245
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : May 11, 2017
Sponsor:
Collaborators:
Octapharma
University of Iceland
Information provided by (Responsible Party):
Jakob Stensballe, MD, PhD, Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment Phase
Septic Shock Drug: OctaplasLG Drug: Ringer-Acetate Phase 2

Detailed 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 18, 2017
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Active Comparator: OctaplasLG
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
OctaplasLG is given as an infusion when resuscitation fluids are required.
Other Name: Octaplas

Placebo Comparator: Ringer-Acetate
standard of care resuscitation fluid Ringer-acetate is a mixture of electrolytes in water to a slightly hypotonic solution.
Drug: Ringer-Acetate
Ringer-acetate is given as an infusion when resuscitation fluids are required.
Other Name: Ringer's Acetate




Primary Outcome Measures :
  1. Microscan at 24 hours [ Time Frame: 24 hours after baseline ]
    Change in microvascular perfusion from baseline to 24 hours after inclusion as evaluated by sidestream darkfield (SDF; MicroVision Medical, Amsterdam, The Netherlands) imaging technique.

  2. Biomarkers at 24 hours [ Time Frame: 24 hours after baseline ]
    Change in biomarkers indicative of endothelial activation and damage (sE-selectin, syndecan-1, thrombomodulin, VEGFR1, VEGF, nucleosomes) from baseline to 24 hours after inclusion.


Secondary Outcome Measures :
  1. 24 hour mortality [ Time Frame: 24 hours after inclusion ]
    Difference in 24 hours mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids such as Ringer-Acetate).

  2. 7 day mortality [ Time Frame: 7 days after inclusion ]
    Difference in 7 day mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids such as Ringer-Acetate).

  3. 30 day mortality [ Time Frame: 30 days after inclusion ]
    Difference in 30 day mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids such as Ringer-Acetate).

  4. 90 day mortality [ Time Frame: 90 days after inclusion ]
    Difference in 90 day mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids such as Ringer-Acetate).

  5. Length of stay in the ICU [ Time Frame: Days, assessed at 30-days and 90-days ]
    The number of days in the ICU after inclusion

  6. Days on vasopressors [ Time Frame: Days, assessed at 30-days and 90-days ]
    The number of days on vasopressors after inclusion

  7. Days on ventilator [ Time Frame: Days, assessed at 30-days and 90-days ]
    The number of days on vasopressors after inclusion

  8. Transfusion requirements [ Time Frame: For the first 7 days after inclusion ]
    Bleeding requiring > 2 RBC / day

  9. Serious Adverse Reactions at 72 hours [ Time Frame: For the first 72 hours after inclusion ]
    Severe adverse reactions, defined as symptomatic thromboembolism and TACO/TRALI

  10. Serious Adverse Reactions at day 30 [ Time Frame: At day 30 after inclusion ]
    Severe adverse reactions, defined as symptomatic thromboembolism and TACO/TRALI

  11. Oxygenation [ Time Frame: At 24 hours, 48 hours, 72 hours and at day 7 after baseline ]
    As evaluated by the PaO2/FiO2-ratio during the ICU stay

  12. RIFLE criteria: Risk, Injury, and Failure, Loss and End-stage kidney disease [ Time Frame: For the first 7 days in the ICU ]
    Acute Kidney Injury according to RIFLE criteria

  13. Renal Replacement Therapy [ Time Frame: For the first 7 days after inclusion ]
    recording whether the patient is receiving dialysis or not


Other Outcome Measures:
  1. Sepsis-related organ failure assessment (SOFA) [ Time Frame: At 24 hours, 48 hours, 72 hours and at day 7 after baseline ]
    Worst score in a 24 hour period

  2. Thrombelastograph (TEG) maximum amplitude at 24 hours [ Time Frame: At 24 hours after baseline ]
    Measuring the maximum amplitude (MA) in mm with TEG

  3. Thrombelastograph (TEG) maximum amplitude at 48 hours [ Time Frame: At 48 hours after baseline ]
    Measuring the maximum amplitude (MA) in mm with TEG

  4. Thrombelastograph (TEG) maximum amplitude at 72 hours [ Time Frame: At 72 hours after baseline ]
    Measuring the maximum amplitude (MA) in mm with TEG

  5. Thrombelastograph (TEG) Functional Fibrinogen maximum amplitude at 24 hours [ Time Frame: At 24 hours after baseline ]
    Measuring the maximum amplitude (MA) in mm with TEG Functional Fibrinogen (FF)

  6. Thrombelastograph (TEG) Functional Fibrinogen maximum amplitude at 48 hours [ Time Frame: At 48 hours after baseline ]
    Measuring the maximum amplitude (MA) in mm with TEG Functional Fibrinogen (FF)

  7. Thrombelastograph (TEG) Functional Fibrinogen maximum amplitude at 72 hours [ Time Frame: At 72 hours after baseline ]
    Measuring the maximum amplitude (MA) in mm with TEG Functional Fibrinogen (FF)

  8. Disseminated Intravascular Coagulation (DIC) score [ Time Frame: At 24 hours, 48 hours, 72 hours and at day 7 after baseline ]
    Total score in a 24 hour period based upon platelets, INR, Fibrinogen and D-dimer lab results.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult intensive care patients (age ≥ 18 years) AND
  2. Sepsis, defined as life-threatening organ dysfunction caused by a dysregulated host response to infection AND
  3. Quick SOFA (qSOFA) with two or more of

    1. Respiratory rate ≥ 22/min
    2. Altered mentation (Glasgow Coma Scale score < 15)
    3. Systolic blood pressure ≤ 100mmHg AND
  4. 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
  5. Requiring infusion of noradrenalin 0.10 mcg/kg/min or more to maintain blood pressure AND
  6. Respiratory failure requiring intubation and mechanical ventilation

Exclusion Criteria:

  1. Documented refusal of blood transfusion OR
  2. Treatment with GPIIb/IIIa inhibitors < 24h from screening OR
  3. Withdrawal from active therapy OR
  4. Previously within 30 days included in an interventional trial OR
  5. Known IgA deficiency with documented antibodies against IgA OR
  6. 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
  7. Known severe deficiencies of protein S OR
  8. Pregnancy (non-pregnancy confirmed by patient being postmenopausal or having a negative urine-hCG) OR
  9. Severe cirrhotic hepatic failure with expected need for treatment with terlipressin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092245


Contacts
Contact: Jakob Stensballe +45 3545 8587 jakob.stensballe@regionh.dk
Contact: Pär I Johansson +45 2372 9202 per.johansson@regionh.dk

Locations
Denmark
ICU Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2200
Contact: Niels E. Clausen, MD    +4551848580    niels.erikstrup.clausen@regionh.dk   
Contact: Jakob Stensballe, MD, PhD.    +4527538687    jakob.stensballe@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Octapharma
University of Iceland
Investigators
Principal Investigator: Niels E Clausen Bispebjerg and Frederiksberg Hospitals, Capitol Region of Copenhagen

Responsible Party: Jakob Stensballe, MD, PhD, Consultant Anaethetist, MD, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03092245     History of Changes
Other Study ID Numbers: VIPER-SHOCK
2017-000427-27 ( EudraCT Number )
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation