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Clinical Trial
. 2019 Apr 29;14(4):e0213057.
doi: 10.1371/journal.pone.0213057. eCollection 2019.

Impact of a new balanced gelatine on electrolytes and pH in the perioperative care

Gernot Marx  1 , Patrick Meybohm  2 , Tobias Schuerholz  1   3 , Gösta Lotz  2 , Mandy Ledinko  1 , Achim W Schindler  1 , Rolf Rossaint  4 , Kai Zacharowski  2
Affiliations
Clinical Trial

Impact of a new balanced gelatine on electrolytes and pH in the perioperative care

Gernot Marx et al. PLoS One. .

Abstract

Introduction: Balanced fluid replacement solutions can possibly reduce the risks for electrolyte imbalances, for acid-base imbalances, and thus for renal failure. To assess the intraoperative change of base excess (BE) and chloride in serum after treatment with either a balanced gelatine/electrolyte solution or a non-balanced gelatine/electrolyte solution, a prospective, controlled, randomized, double-blind, dual centre phase III study was conducted in two tertiary care university hospitals in Germany.

Material and methods: 40 patients of both sexes, aged 18 to 90 years, who were scheduled to undergo elective abdominal surgery with assumed intraoperative volume requirement of at least 15 mL/kg body weight gelatine solution were included. Administration of study drug was performed intravenously according to patients need. The trigger for volume replacement was a central venous pressure (CVP) minus positive end-expiratory pressure (PEEP) <10 mmHg (CVP <10 mmHg). The crystalloid:colloid ratio was 1:1 intra- and postoperatively. The targets for volume replacement were a CVP between 10 and 14 mmHg minus PEEP after treatment with vasoactive agent and mean arterial pressure (MAP) > 65 mmHg.

Results: The primary endpoints, intraoperative changes of base excess -2.59 ± 2.25 (median: -2.65) mmol/L (balanced group) and -4.79 ± 2.38 (median: -4.70) mmol/L (non-balanced group)) or serum chloride 2.4 ± 1.9 (median: 3.0) mmol/L and 5.2 ± 3.1 (median: 5.0) mmol/L were significantly different (p = 0.0117 and p = 0.0045, respectively). In both groups (each n = 20) the investigational product administration in terms of volume and infusion rate was comparable throughout the course of the study, i.e. before, during and after surgery.

Discussion: Balanced gelatine solution 4% combined with a balanced electrolyte solution demonstrated significant smaller impact on blood gas analytic parameters in the primary endpoints BE and serum chloride when compared to a non-balanced gelatine solution 4% combined with NaCl 0.9%. No marked treatment differences were observed with respect to haemodynamics, coagulation and renal function.

Trial registration: ClinicalTrials.gov (NCT01515397) and clinicaltrialsregister.eu, EudraCT number 2010-018524-58.

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Conflict of interest statement

This study was supported by a restricted grant of B. Braun Meldungen AG, Germany. GM received honoria for consulting and research grants by B. Braun Melsungen AG and Adrenomed, lecture fees by B. Braun Melsungen AG. KZ has received payments for lectures and consulting from B. Braun Melsungen AG and Fresenius Kabi as well as funding for a clinical trial. PM has received payments for lectures and consulting from B. Braun Melsungen AG and Fresenius Kabi as well as funding for a clinical trial. RR received honoria for consulting from Fresenius; he received lecture fees from Fresenius and B. Braun Melsungen AG and is Editor-in-Chief of Der Anaesthesist and editor of the European Journal of Anaesthesiology. TS received honoria for board membership by Astellas Pharma GmbH, lecture fees by Astellas Pharma, Bayer Health Care, B. Braun Melsungen AG and Astra Zeneca and research grants by Bayer Health Care and Astellas Pharma GmbH. All the other authors declare that they have no competing interests. This does not alter our adherence to PLOS One policies on sharing data and materials.

Figures

Fig 1
Fig 1. Study flow chart.
Fig 2
Fig 2. Change of base excess from baseline until the end of surgery.
Data presented as mean ± SD; p = 0.0117.
Fig 3
Fig 3. Change of serum chloride from baseline until the end of surgery.
Data presented as mean ± SD; p = 0.0045.
See this image and copyright information in PMC

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