Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2024 Sep;64(9):1653-1661.
doi: 10.1111/trf.17939. Epub 2024 Jul 8.

Plasma as endothelial rescue in septic shock: A randomized, phase 2a pilot trial

Niels E Clausen  1 , Christian S Meyhoff  1   2 , Hanne H Henriksen  2   3 , Anne Lindhardt  4 , Frank C Pott  1 , Thomas Bech Lunen  4 , Mikkel Gybel-Brask  3 , Theis Lange  5 , Pär I Johansson  2   3 , Jakob Stensballe  3   6
Affiliations
Clinical Trial

Plasma as endothelial rescue in septic shock: A randomized, phase 2a pilot trial

Niels E Clausen et al. Transfusion. 2024 Sep.

Abstract

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®.

Keywords: crystalloids; endothelium; glycocalyx; plasma; sepsis.

PubMed Disclaimer

References

REFERENCES

    1. Vincent J, Jones G, David S, Olariu E, Cadwell KK. Frequency and mortality of septic shock in Europe and North America: a systematic review and meta‐analysis. Critical Care. 2019;23:1–11.
    1. Holst LB, Haase N, Wetterslev J, Wernerman J, Guttormsen AB, Karlsson S, et al. Lower versus higher hemoglobin threshold for transfusion in septic shock. N Engl J Med. 2014;371(15):1381–1391.
    1. Singer M, Deutschman CS, Seymour C, Shankar‐Hari M, Annane D, Bauer M, et al. The third international consensus definitions for sepsis and septic shock (sepsis‐3). JAMA – J Am Med Assoc. 2016;315(8):801–810.
    1. Cecconi M, Evans L, Levy M, Rhodes A. Sepsis and septic shock. Lancet. 2018;392(10141):75–87.
    1. Guidet B, Aegerter P, Gauzit R, Meshaka P, Dreyfuss D. Incidence and impact of organ dysfunctions associated with sepsis. Chest. 2005;127(3):942–951.

Publication types

LinkOut - more resources