You are here

  • Home
  • Archive
  • Volume 3, Issue 1
  • Protocol for a pilot randomized controlled trial comparing plasma with balanced crystalloid resuscitation in surgical and trauma patients with septic shock

Article Text

Article menu

Download PDFPDF

Brief report
Protocol for a pilot randomized controlled trial comparing plasma with balanced crystalloid resuscitation in surgical and trauma patients with septic shock
  1. Shuyan Wei1,2,3,
  2. Lillian S Kao1,2,3,
  3. Henry E Wang1,4,
  4. Ronald Chang1,2,
  5. Jeanette Podbielski1,
  6. John B Holcomb1,2,
  7. Charles E Wade1,2
  1. 1 Center for Translational Injury Research, McGovern Medical School at the University of Texas Health Science Center, Houston, Texas, USA
  2. 2 Department of Surgery, McGovern Medical School at the University of Texas Health Science Center, Houston, Texas, USA
  3. 3 Center for Surgical Trials and Evidence-based Practice, Departments of Surgery and Pediatric Surgery, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA
  4. 4 Department of Emergency Medicine, McGovern Medical School at the University of Texas Health Science Center, Houston, Texas, USA
  1. Correspondence to Dr Shuyan Wei, Department of Surgery, McGovern Medical School at the University of Texas Health Science Center, Houston, Texas 77030, USA; shuyan.wei{at}uth.tmc.edu

Abstract

Background Septic shock is a public health problem with high mortality. There remains a knowledge gap regarding the optimal resuscitation fluid to improve clinical outcomes, and the underlying mechanism by which fluids exert their effect. Shock-induced endotheliopathy (SHINE) is thought to be a shared pathophysiologic mechanism associated with worsened outcomes in critically ill trauma and sepsis patients. SHINE is characterized by breakdown of the glycocalyx—a network of membrane-bound proteoglycans and glycoproteins that covers the endothelium. This has been associated with capillary leakage and microvascular thrombosis, organ dysfunction, and mortality. Biomarkers of SHINE have been shown to correlate with clinical outcomes in patients with septic shock. Interventions to mitigate SHINE may improve outcomes in patients with septic shock. In surgical/trauma patients with septic shock, initial plasma resuscitation as compared with balanced crystalloid (BC) resuscitation will mitigate biomarkers of SHINE and improve clinical outcomes.

Methods A pilot, single-center randomized controlled trial (RCT) will compare initial plasma to BC resuscitation in surgical and trauma patients with septic shock. Patients will be enrolled based on a Sepsis Screening Score of ≥4 with a suspected source of infection. Patient randomization only occurs if they meet the criteria: (1) hypotension with mean arterial pressure <65 mm Hg, and (2) evidence of hypoperfusion including lactic acid >4 mmol/L, altered mental status or decreased urine output of <0.5 mL/kg in the past hour.

Results The primary outcome is a reduction in serum biomarkers at 6 hours. Secondary outcomes will include clinical outcomes such as intensive care unit-free days, organ dysfunction, and in-hospital mortality.

Discussion This trial will provide insights into the effects of initial plasma resuscitation on SHINE. Furthermore, it will provide unbiased estimates regarding the feasibility, safety, and clinical efficacy of plasma resuscitation in septic shock on which to base subsequent adequately powered multicenter RCTs.

Trail registration number ClinicalTrials.gov (NCT03366220).

  • septic shock
  • resuscitation fluid
  • endothelial dysfunction
  • plasma

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/tsaco-2018-000220

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • Contributors All authors included in the article contributed to the conception, design, implementation of the trial and drafting of the article.

    • Funding SW is supported by the National Institute of General Medical Sciences of the National Institutes of Health under award number R01GM085232.

    • Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Advancing Translational Sciences or the National Institutes of Health.

    • Competing interests None declared.

    • Patient consent Not required.

    • Ethics approval This study has been approved by our institutional review board. Committee for the Protection of Human Subjects (HSC-MS-17-0714).

    • Provenance and peer review Not commissioned; internally peer reviewed.