Plasma as endothelial rescue in septic shock: A randomized, phase 2a pilot trial
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Plasma as endothelial rescue in septic shock : A randomized, phase 2a pilot trial. / Clausen, Niels E.; Meyhoff, Christian S.; Henriksen, Hanne H.; Lindhardt, Anne; Pott, Frank C.; Lunen, Thomas Bech; Gybel-Brask, Mikkel; Lange, Theis; Johansson, Pär I.; Stensballe, Jakob.
I: Transfusion, 2024.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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T1 - Plasma as endothelial rescue in septic shock
T2 - A randomized, phase 2a pilot trial
AU - Clausen, Niels E.
AU - Meyhoff, Christian S.
AU - Henriksen, Hanne H.
AU - Lindhardt, Anne
AU - Pott, Frank C.
AU - Lunen, Thomas Bech
AU - Gybel-Brask, Mikkel
AU - Lange, Theis
AU - Johansson, Pär I.
AU - Stensballe, Jakob
N1 - Publisher Copyright: © 2024 AABB.
PY - 2024
Y1 - 2024
N2 - Background: Septic shock is associated with high morbidity and mortality, the endothelium plays an important role. Crystalloids is standard of care to maintain intravascular volume. Plasma is associated with improved endothelial integrity and restoration of the glycocalyx layer. We evaluated the efficacy and safety aspects of cell-free and pathogen inactivated pooled plasma (OctaplasLG®) as resuscitation in septic shock patients. Study Design and Methods: This randomized, investigator-initiated phase IIa trial ran at a Danish single center intensive care unit, from 2017 to 2019. Patients were 18 years of age or older with septic shock and randomized to fluid optimization with OctaplasLG® or Ringer-acetate in the first 24 h. The primary endpoints were changes in biomarkers indicative of endothelial activation, damage, and microvascular perfusion from baseline to 24 h. Safety events and mortality were assessed during 90 days. Results: Forty-four patients were randomized, 20 to OctaplasLG versus 24 to Ringer-acetate. The median age was 69, and 55% were men. Median Sequential Organ Failure Assessment score was 13. Baseline differences favoring the Ringer-acetate group were observed. The OctaplasLG® group was resuscitated with 740 mL plasma and the Ringer-acetate group with 841 mL crystalloids. There was no significant change in the microvascular perfusion or five biomarkers except VEGFR1 change, which was higher in patients receiving OctaplasLG® 0.12(SD 0.37) versus Ringer-acetate −0.24 (SD 0.39), with mean difference 0.36 (95% CI, 0.13–0.59, p =.003) in favor of Ringer-acetate. Discussion: This study found that fluid resuscitation with OctaplasLG® in critically ill septic shock patients is feasible. Baseline confounding prevented assessment of the potential effect of OctaplasLG®.
AB - Background: Septic shock is associated with high morbidity and mortality, the endothelium plays an important role. Crystalloids is standard of care to maintain intravascular volume. Plasma is associated with improved endothelial integrity and restoration of the glycocalyx layer. We evaluated the efficacy and safety aspects of cell-free and pathogen inactivated pooled plasma (OctaplasLG®) as resuscitation in septic shock patients. Study Design and Methods: This randomized, investigator-initiated phase IIa trial ran at a Danish single center intensive care unit, from 2017 to 2019. Patients were 18 years of age or older with septic shock and randomized to fluid optimization with OctaplasLG® or Ringer-acetate in the first 24 h. The primary endpoints were changes in biomarkers indicative of endothelial activation, damage, and microvascular perfusion from baseline to 24 h. Safety events and mortality were assessed during 90 days. Results: Forty-four patients were randomized, 20 to OctaplasLG versus 24 to Ringer-acetate. The median age was 69, and 55% were men. Median Sequential Organ Failure Assessment score was 13. Baseline differences favoring the Ringer-acetate group were observed. The OctaplasLG® group was resuscitated with 740 mL plasma and the Ringer-acetate group with 841 mL crystalloids. There was no significant change in the microvascular perfusion or five biomarkers except VEGFR1 change, which was higher in patients receiving OctaplasLG® 0.12(SD 0.37) versus Ringer-acetate −0.24 (SD 0.39), with mean difference 0.36 (95% CI, 0.13–0.59, p =.003) in favor of Ringer-acetate. Discussion: This study found that fluid resuscitation with OctaplasLG® in critically ill septic shock patients is feasible. Baseline confounding prevented assessment of the potential effect of OctaplasLG®.
KW - crystalloids
KW - endothelium
KW - glycocalyx
KW - plasma
KW - sepsis
U2 - 10.1111/trf.17939
DO - 10.1111/trf.17939
M3 - Journal article
C2 - 38973502
AN - SCOPUS:85197710881
JO - Transfusion
JF - Transfusion
SN - 0041-1132
ER -
ID: 398559963