Patients with septic shock admitted to the intensive care unit MedDRA version: 19.0 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: octaplasLG
Pharmaceutical Form: Infusion
INN or Proposed INN: Octaplas
CAS Number: N/A
Other descriptive name: HUMAN PLASMA POOLED AND TREATED FOR VIRUS INACTIVATION
Concentration unit: IU
Sponsors
Section for Transfusion Medicine, Capitol Region Blood Bank
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Adult intensive care patients (age =18 years) AND 2. Sepsis, defined as suspected or confirmed site of infection or positive blood culture and =2 of 4 systemic inflammatory response syndrome (SIRS) criteria fulfilled within the last 24h: a) Temperature = 36° C or = 38°C b) Heart rate = 90 beats per minute c) Mechanical ventilation for acute respiratory process or respiratory rate = 20 breaths per minute or PaCO2 10% bands AND 3. Septic shock requiring infusion of vasopressor/inotropic agents to maintain blood pressure Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Exclusion criteria Patients are not eligible for inclusion in this trial if they fulfill one or more of the following 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 a randomised trial, if known at the time of enrolment 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of octaplasLG® administration as compared to crystalloids (standard) in patients with septic shock;Secondary Objective: Safety of octaplasLG® administration as compared to crystalloids (standard) in patients with septic shock;Primary end point(s): Primary endpoints • Change in microvascular perfusion from baseline to 6 hours after inclusion as evaluated by sidestream darkfield (SDF; MicroVision Medical, Amsterdam, The Netherlands) imaging technique. • Change in biomarkers indicative of endothelial activation and damage (sE-selectin, syndecan-1, thrombomodulin, sVE-cadherin, nucleosomes) from baseline to 6 hours after inclusion ;Timepoint(s) of evaluation of this end point: 6 hours after inclusion in the trial as compared to baseline (inclusion) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints • Difference in 6 hours, 24 hours, 7, 30 and 90 day mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids) • Length of stay in the ICU • Days on vasopressors • Days on ventilator • Bleeding requiring > 2 RBC / day during the first 72 hours • Severe adverse reactions, defined as symptomatic thromboembolism and TACO/TRALI during the first 72 hours. Safety endpoints • Maximal change in SOFA score from baseline to 6, 24, 48 and 72 hours as well as ICU day 7 • Acute Kidney Injury (AKI) according to RIFLE Criteria in the first 7 days • Renal replacement therapy as deemed necessary by the attending physician during the first 30 days post-randomization. • Thrombelastograph maximum amplitude (clot strength) in TEG and TEG Functional Fibrinogen (FF) at 6, 24, 48, 72 hours as compared to baseline • Disseminated intravascular coagulation score (DIC) during the first 72 hours as well as day 7;Timepoint(s) of evaluation of this end point: Difference in 6 hours, 24 hours, 7, 30 and 90 day mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids) Other secondary and safety endpoint during the first 72 hours and at 7 days | — |
Countries
Denmark
Contacts
Public ContactPär I. Johansson
Section for Transfusion Medicine, Capitol Region Blood Bank
Outcome results
None listed