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

Septic Shock Clinical Trial

— VIPER-SHOCK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03092245
• Other study ID #: VIPER-SHOCK
• Secondary ID: 2017-000427-27
• Status: Completed
• Phase: Phase 2
• Start date: April 18, 2017
• Est. completion date: April 17, 2019

Study information

• Verified date: January 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 17, 2019
• Est. primary completion date: April 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• OctaplasLG
OctaplasLG is given as an infusion when resuscitation fluids are required.
• Ringer-Acetate
Ringer-acetate is given as an infusion when resuscitation fluids are required.

Locations

Country	Name	City	State
Denmark	ICU Bispebjerg Hospital	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Octapharma, University of Iceland

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sepsis-related organ failure assessment (SOFA)	Worst score in a 24 hour period	At 24 hours, 48 hours, 72 hours and at day 7 after baseline
Other	Thrombelastograph (TEG) maximum amplitude at 24 hours	Measuring the maximum amplitude (MA) in mm with TEG	At 24 hours after baseline
Other	Thrombelastograph (TEG) maximum amplitude at 48 hours	Measuring the maximum amplitude (MA) in mm with TEG	At 48 hours after baseline
Other	Thrombelastograph (TEG) maximum amplitude at 72 hours	Measuring the maximum amplitude (MA) in mm with TEG	At 72 hours after baseline
Other	Thrombelastograph (TEG) Functional Fibrinogen maximum amplitude at 24 hours	Measuring the maximum amplitude (MA) in mm with TEG Functional Fibrinogen (FF)	At 24 hours after baseline
Other	Thrombelastograph (TEG) Functional Fibrinogen maximum amplitude at 48 hours	Measuring the maximum amplitude (MA) in mm with TEG Functional Fibrinogen (FF)	At 48 hours after baseline
Other	Thrombelastograph (TEG) Functional Fibrinogen maximum amplitude at 72 hours	Measuring the maximum amplitude (MA) in mm with TEG Functional Fibrinogen (FF)	At 72 hours after baseline
Other	Disseminated Intravascular Coagulation (DIC) score	Total score in a 24 hour period based upon platelets, INR, Fibrinogen and D-dimer lab results.	At 24 hours, 48 hours, 72 hours and at day 7 after baseline
Primary	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
Primary	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	24 hour mortality	Difference in 24 hours mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids such as Ringer-Acetate).	24 hours after inclusion
Secondary	7 day mortality	Difference in 7 day mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids such as Ringer-Acetate).	7 days after inclusion
Secondary	30 day mortality	Difference in 30 day mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids such as Ringer-Acetate).	30 days after inclusion
Secondary	90 day mortality	Difference in 90 day mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids such as Ringer-Acetate).	90 days after inclusion
Secondary	Length of stay in the ICU	The number of days in the ICU after inclusion	Days, assessed at 30-days and 90-days
Secondary	Days on vasopressors	The number of days on vasopressors after inclusion	Days, assessed at 30-days and 90-days
Secondary	Days on ventilator	The number of days on vasopressors after inclusion	Days, assessed at 30-days and 90-days
Secondary	Transfusion requirements	Bleeding requiring > 2 RBC / day	For the first 7 days after inclusion
Secondary	Serious Adverse Reactions at 72 hours	Severe adverse reactions, defined as symptomatic thromboembolism and TACO/TRALI	For the first 72 hours after inclusion
Secondary	Serious Adverse Reactions at day 30	Severe adverse reactions, defined as symptomatic thromboembolism and TACO/TRALI	At day 30 after inclusion
Secondary	Oxygenation	As evaluated by the PaO2/FiO2-ratio during the ICU stay	At 24 hours, 48 hours, 72 hours and at day 7 after baseline
Secondary	RIFLE criteria: Risk, Injury, and Failure, Loss and End-stage kidney disease	Acute Kidney Injury according to RIFLE criteria	For the first 7 days in the ICU
Secondary	Renal Replacement Therapy	recording whether the patient is receiving dialysis or not	For the first 7 days after inclusion