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Open randomized trial of the effects of 6% hydroxyethyl starch 130/0.4/9 and 5% albumin on safety profile, volume efficacy, and glycocalyx degradation in hepatic and pancreatic surgery

Journal of Anesthesia volume 34, pages 912–923 (2020)Cite this article

Abstract

Purpose

The aim of this study was to evaluate the effects of hydroxyethyl starch (HES) 130/0.4/9 compared to 5% albumin on renal and coagulation safety profiles, volume efficacy and glycocalyx degradation in major abdominal surgery.

Methods

The study was approved by the institutional ethics committee as a single center, open-labeled randomized trial. Fifty patients undergoing hepatic or pancreatic surgery were randomly assigned to the HES group (n = 25), who received HES 130/0.4/9, or the Albumin group (n = 25), who received 5% albumin. Ringer’s acetate solution (3 ml/kg/h) and colloid solution (2 mL/kg/h) were infused and goal-directed fluid management was performed to stabilize hemodynamics. Perioperative changes and differences in serum creatinine, N-acetyl-beta-d-glucosaminidase (NAG), hemodynamics, coagulation parameters and glycocalyx biomarkers were compared between the groups. Blood loss and requirements for transfusion and vasoactive agents were also examined. Statistical analysis was performed by Mann–Whitney U tests, chi-square or Fisher exact test, with P < 0.05 taken to be significant.

Results

Serum creatinine levels did not differ between the HES and Albumin groups (median: 0.67 vs. 0.75 mg/dL at anesthesia induction, 0.82 vs. 0.83 mg/dL at ICU admission, 0.67 vs. 0.73 mg/dL one day after surgery, 0.68 vs. 0.70 mg/dL one month after surgery). NAG, coagulation parameters, hemodynamics, glycocalyx biomarkers, intraoperative blood loss, transfusion and use of vasoactive agents did not differ between the groups.

Conclusion

HES 130/0.4/9 can be used as safely and effectively as 5% albumin. Glycocalyx degradation did not differ between use of these solutions in major abdominal surgery.

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Acknowledgements

We give special thanks to Professor Hideki Miyao (Department of Anesthesiology, Saitama Medical Center, Saitama Medical University, Japan), Associate Professor Yohei Kawasaki (Biostatistics Section, Clinical Research Center, Chiba University Hospital) and Yusuke Mazda (Clinical Fellow in Perioperative Quality Improvement and Patient Safety, Mount Sinai Hospital, University of Toronto) for their help with research design, including statistical review, and preparation of the manuscript. We also thank the doctors of the Hepato-biliary-Pancreatic Surgery Department and the staff members of the Anesthesiology Department (Saitama Medical Center, Saitama Medical University) for their support and assistance.

Funding

This study was funded by Saitama Medical University.

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Authors and Affiliations

  1. Department of Anesthesiology, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan

    Toshinari Suzuki & Kaoru Koyama

Authors
  1. Toshinari Suzuki
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  2. Kaoru Koyama
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Contributions

TS: collection of data and drafting of the manuscript; KK: final approval of the version to be published.

Corresponding author

Correspondence to Toshinari Suzuki.

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Conflict of interest

All authors have no conflicts of interest to disclose.

Registration of clinical trials

The study was registered prior to patient enrollment in the University hospital Medical Information Network (UMIN) clinical trials registry by number UMIN00001347. Principal investigator: Kaoru Koyama. Data for registration: April 1, 2014. Saitama Medical Center, Saitama Medical University Institutional Review Board (Clinical Trial Number 952). Principal investigator: Toshinari Suzuki. Data for registration: May 2, 2014.

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Suzuki, T., Koyama, K. Open randomized trial of the effects of 6% hydroxyethyl starch 130/0.4/9 and 5% albumin on safety profile, volume efficacy, and glycocalyx degradation in hepatic and pancreatic surgery. J Anesth 34, 912–923 (2020). https://doi.org/10.1007/s00540-020-02847-y

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