Efficacy and safety of OctaplasLG® administration vs. crystalloids (standard) in patients with septic shock - a randomized, controlled, open-label investigator-initiated pilot trial
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
OctaplasLG is given as an infusion when resuscitation fluids are required.
Ringer-acetate is given as an infusion when resuscitation fluids are required.
ICU Bispebjerg Hospital
Copenhagen, Denmark
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.
Time frame: 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.
Time frame: 24 hours after baseline
24 hour mortality
Difference in 24 hours mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids such as Ringer-Acetate).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 90 days after inclusion
Length of stay in the ICU
The number of days in the ICU after inclusion
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Time frame: Days, assessed at 30-days and 90-days
Days on vasopressors
The number of days on vasopressors after inclusion
Time frame: Days, assessed at 30-days and 90-days
Days on ventilator
The number of days on vasopressors after inclusion
Time frame: Days, assessed at 30-days and 90-days
Transfusion requirements
Bleeding requiring \> 2 RBC / day
Time frame: For the first 7 days after inclusion
Serious Adverse Reactions at 72 hours
Severe adverse reactions, defined as symptomatic thromboembolism and TACO/TRALI
Time frame: For the first 72 hours after inclusion
Serious Adverse Reactions at day 30
Severe adverse reactions, defined as symptomatic thromboembolism and TACO/TRALI
Time frame: At day 30 after inclusion
Oxygenation
As evaluated by the PaO2/FiO2-ratio during the ICU stay
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
Acute Kidney Injury according to RIFLE criteria
Time frame: For the first 7 days in the ICU
Renal Replacement Therapy
recording whether the patient is receiving dialysis or not
Time frame: For the first 7 days after inclusion