Septic ShockPhase 2VIPER-SHOCKNCT03092245
Vasculopathic Injury and Plasma as Endothelial Rescue in Septic Shock (SHOCK) Trial
A Phase 2 study testing OctaplasLG and Ringer-Acetate in people with Septic Shock, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- OctaplasLG and Ringer-Acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Apr 2017to 17 Apr 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Efficacy and safety of OctaplasLG® administration vs. crystalloids (standard) in patients with septic shock - a randomized, controlled, open-label investigator-initiated pilot trial
Read the 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.
- Conditions
- Septic Shock
- Being tested
- OctaplasLG, Ringer-Acetate
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OctaplasLGDrug
Also called Octaplas
OctaplasLG is given as an infusion when resuscitation fluids are required.
Ringer-AcetateDrug
Also called Ringer's Acetate
Ringer-acetate is given as an infusion when resuscitation fluids are required.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Ringer-Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 hours after baseline
Secondary outcomes (13)
24 hour mortality
Difference in 24 hours mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids such as Ringer-Acetate).
Measured: 24 hours after inclusion
7 day mortality
Difference in 7 day mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids such as Ringer-Acetate).
Measured: 7 days after inclusion
30 day mortality
Difference in 30 day mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids such as Ringer-Acetate).
Measured: 30 days after inclusion
90 day mortality
Difference in 90 day mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids such as Ringer-Acetate).
Measured: 90 days after inclusion
Length of stay in the ICU
The number of days in the ICU after inclusion
Measured: Days, assessed at 30-days and 90-days
Days on vasopressors
The number of days on vasopressors after inclusion
Measured: Days, assessed at 30-days and 90-days
Days on ventilator
The number of days on vasopressors after inclusion
Measured: Days, assessed at 30-days and 90-days
Transfusion requirements
Bleeding requiring > 2 RBC / day
Measured: For the first 7 days after inclusion
Serious Adverse Reactions at 72 hours
Severe adverse reactions, defined as symptomatic thromboembolism and TACO/TRALI
Measured: For the first 72 hours after inclusion
Serious Adverse Reactions at day 30
Severe adverse reactions, defined as symptomatic thromboembolism and TACO/TRALI
Measured: At day 30 after inclusion
Oxygenation
As evaluated by the PaO2/FiO2-ratio during the ICU stay
Measured: At 24 hours, 48 hours, 72 hours and at day 7 after baseline
RIFLE criteria: Risk, Injury, and Failure, Loss and End-stage kidney disease
Acute Kidney Injury according to RIFLE criteria
Measured: For the first 7 days in the ICU
Renal Replacement Therapy
recording whether the patient is receiving dialysis or not
Measured: For the first 7 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start18 Apr 2017
- Primary completion17 Apr 2019
- Study completion17 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Octapharma, University of Iceland
- Responsible party
- Principal investigator, Jakob Stensballe, MD, PhD, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Niels E Clausen, Principal investigator, Bispebjerg and Frederiksberg Hospitals, Capitol Region of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092245
- Sponsor's protocol ID
- VIPER-SHOCK
- Other IDs
- 2017-000427-27, 2017
- Acronym
- VIPER-SHOCK
- Status last verified
- Jan 2023
- First submitted
- 21 Feb 2017
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03092245
- Acronym / sponsor ID
- VIPER-SHOCK / VIPER-SHOCK
- Conditions
- Septic Shock
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Octapharma, University of Iceland
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 17 Apr 2019 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy and safety of OctaplasLG® administration vs. crystalloids (standard) in patients with septic shock - a randomized, controlled, open-label investigator-initiated pilot trial
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OctaplasLG | Active comparator | Drug: OctaplasLGOctaplasLG® 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. |
| Ringer-Acetate | Placebo comparator | Drug: Ringer-Acetatestandard of care resuscitation fluid Ringer-acetate is a mixture of electrolytes in water to a slightly hypotonic solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OctaplasLGAlso: OctaplasOctaplasLG is given as an infusion when resuscitation fluids are required. | Drug | OctaplasLG |
| Ringer-AcetateAlso: Ringer's AcetateRinger-acetate is given as an infusion when resuscitation fluids are required. | Drug | Ringer-Acetate |
Primary outcome
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.
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.
13 secondary outcomes
24 hour mortality
Time frame: 24 hours after inclusion
7 day mortality
Time frame: 7 days after inclusion
30 day mortality
Time frame: 30 days after inclusion
90 day mortality
Time frame: 90 days after inclusion
Length of stay in the ICU
Time frame: Days, assessed at 30-days and 90-days
Days on vasopressors
Time frame: Days, assessed at 30-days and 90-days
Days on ventilator
Time frame: Days, assessed at 30-days and 90-days
Transfusion requirements
Time frame: For the first 7 days after inclusion
Serious Adverse Reactions at 72 hours
Time frame: For the first 72 hours after inclusion
Serious Adverse Reactions at day 30
Time frame: At day 30 after inclusion
Oxygenation
Time frame: At 24 hours, 48 hours, 72 hours and at day 7 after baseline
RIFLE criteria: Risk, Injury, and Failure, Loss and End-stage kidney disease
Time frame: For the first 7 days in the ICU
Renal Replacement Therapy
Time frame: For the first 7 days after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
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RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels E Clausen principal investigator
Bispebjerg and Frederiksberg Hospitals, Capitol Region of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OctaplasLG and Ringer-Acetate in people with Septic Shock, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microscan at 24 hours (time frame: 24 hours after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.