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

NCT ID: NCT03092245

Last Updated: 2023-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-18
• Study Completion Date: 2019-04-17

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

OctaplasLG

Intervention Type: DRUG

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

Ringer-Acetate

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

Group Type: PLACEBO_COMPARATOR

Ringer-Acetate

Intervention Type: DRUG

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

Interventions

OctaplasLG

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

Intervention Type: DRUG

Ringer-Acetate

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

Intervention Type: DRUG

Other Intervention Names

Octaplas; Ringer's Acetate

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Octapharma

INDUSTRY

Sponsor Role: collaborator

University of Iceland

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Jakob Stensballe, MD, PhD

Consultant Anaethetist, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Niels E Clausen

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg and Frederiksberg Hospitals, Capitol Region of Copenhagen

Locations

ICU Bispebjerg Hospital

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

2017-000427-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VIPER-SHOCK

Identifier Type: -

Identifier Source: org_study_id