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      The impact of phosphate-balanced crystalloid infusion on acid-base homeostasis (PALANCE study): study protocol for a randomized controlled trial

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          Abstract

          Background

          This study aims to investigate the effects of a modified, balanced crystalloid including phosphate in a perioperative setting in order to maintain a stable electrolyte and acid-base homeostasis in the patient.

          Methods/design

          This is a single-centre, open-label, randomized controlled trial involving two parallel groups of female patients comparing a perioperative infusion regime with sodium glycerophosphate and Jonosteril® (treatment group) or Jonosteril® (comparator) alone. The primary endpoint is to maintain a stable concentration of weak acids [A -] according to the Stewart approach of acid-base balance. Secondary endpoints are measurement of serum phosphate levels, other acid-base parameters such as the strong ion difference (SID), the onset and severity of postoperative nausea and vomiting (PONV), electrolyte levels and their excretion in the urine, monitoring of renal function and glycocalyx components, haemodynamics, amounts of catecholamines and other vasopressors used and the safety of the infusion regime.

          Discussion

          Perioperative fluid replacement with the use of currently available crystalloid preparations still fail to maintain a stable acid-base balance and experts agree that common balanced solutions are still not ideal. This study aims to investigate the effectivity and safety of a new crystalloid solution by adding sodium glycerophosphate to a standardized crystalloid preparation in order to maintain a balanced perioperative acid-base homeostasis.

          Trial registration

          EudraCT number 201002422520. Registered on 30 November 2010.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s13063-017-2051-z) contains supplementary material, which is available to authorized users.

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          Most cited references24

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          Prediction of Creatinine Clearance from Serum Creatinine

          Donald W Cockcroft, Henry Gault (1976)
          A formula has been developed to predict creatinine clearance (C cr ) from serum creatinine (S cr ) in adult males: Ccr = (140 – age) (wt kg)/72 × S cr (mg/100ml) (15% less in females). Derivation included the relationship found between age and 24-hour creatinine excretion/kg in 249 patients aged 18–92. Values for C cr were predicted by this formula and four other methods and the results compared with the means of two 24-hour C cr’s measured in 236 patients. The above formula gave a correlation coefficient between predicted and mean measured Ccr·s of 0.83; on average, the difference between predicted and mean measured values was no greater than that between paired clearances. Factors for age and body weight must be included for reasonable prediction.
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            A balanced view of balanced solutions

            Bertrand Guidet, Neil Soni, Giorgio Della Rocca … (2010)
            The present review of fluid therapy studies using balanced solutions versus isotonic saline fluids (both crystalloids and colloids) aims to address recent controversy in this topic. The change to the acid-base equilibrium based on fluid selection is described. Key terms such as dilutional-hyperchloraemic acidosis (correctly used instead of dilutional acidosis or hyperchloraemic metabolic acidosis to account for both the Henderson-Hasselbalch and Stewart equations), isotonic saline and balanced solutions are defined. The review concludes that dilutional-hyperchloraemic acidosis is a side effect, mainly observed after the administration of large volumes of isotonic saline as a crystalloid. Its effect is moderate and relatively transient, and is minimised by limiting crystalloid administration through the use of colloids (in any carrier). Convincing evidence for clinically relevant adverse effects of dilutional-hyperchloraemic acidosis on renal function, coagulation, blood loss, the need for transfusion, gastrointestinal function or mortality cannot be found. In view of the long-term use of isotonic saline either as a crystalloid or as a colloid carrier, the paucity of data documenting detrimental effects of dilutional-hyperchloraemic acidosis and the limited published information on the effects of balanced solutions on outcome, we cannot currently recommend changing fluid therapy to the use of a balanced colloid preparation.
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              The role of serum proteins in acid-base equilibria.

              James J Figge, Henrik Rossing, V FENCL (1991)
              Serum proteins act as weak acids and participate in acid-base balance. Their effects are imprecisely quantified; in particular, the roles of albumin and globulins need reevaluation. We approached the problem in three steps. First, in artificial solutions resembling serum but with human serum albumin as the only protein moiety, we varied the strong ion difference (SID), partial pressure of carbon dioxide (Pco2) and the concentration of albumin [( Alb]) and fixed the concentration of inorganic phosphate [( Pi]). We measured pH and derived the charges on albumin. Second, extending the work of Stewart (Stewart PA. How to understand acid-base. A quantitative acid-base primer for biology and medicine. New York: Elsevier, 1981:1-286), we developed a mathematical model that solves for pH and for the charges on albumin as functions of SID, Pco2, [Pi], and [Alb]. The calculated values fit the observed values well; that is, the model describes well the behavior of these solutions over a wide range of simulated complex acid-base disturbances. Finally, in human serum samples containing both albumin and globulins, we varied SID, Pco2, and total protein concentration [( TP]); we fixed [Pi] and then measured pH and derived the charges on proteins as above. When we applied to these data the computer model developed for albumin alone, the calculated pH and derived charges on albumin values agreed well with the observed pH and derived charges on proteins. We conclude first that human serum globulins play a negligible role in acid-base equilibria, and second, that in normal human serum at pH 7.40 with [TP] = 7 and [Alb] = 4.3 gm/dl, the charges attributed to proteins are approximately 12 mEq/L; this is substantially less than the value of approximately 17 mEq/L given by many contemporary texts, based on work of van Slyke et al. (van Slyke DD, Hastings AB, Hiller A, Sendroy J Jr. Studies of gas and electrolyte equilibria in blood. XIV. Amounts of alkali bound by serum albumin and globulin. J Biol Chem 1928;79:769-80). These findings should be considered when evaluating acid-base balance in patients with abnormal serum albumin concentration, for example, when interpreting values of the anion gap.
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                Author and article information

                Contributors
                Judith-Irina Pagel:
                ORCID: http://orcid.org/0000-0003-3605-955X
                judith.pagel@med.uni-muenchen.de
                Nikolai Hulde: nikolai.hulde@med.uni-muenchen.de
                Tobias Kammerer: tobias.kammerer@med.uni-muenchen.de
                Michaela Schwarz: schwarz@chkmb.de
                Daniel Chappell: daniel.chappell@med.uni-muenchen.de
                Alexander Burges: alexander.burges@med.uni-muenchen.de
                Klaus Hofmann-Kiefer: klaus.hofmann-kiefer@med.uni-muenchen.de
                Markus Rehm: markus.rehm@med.uni-muenchen.de
                Journal
                Journal ID (nlm-ta): Trials
                Journal ID (iso-abbrev): Trials
                Title: Trials
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1745-6215
                Publication date (Electronic): 10 July 2017
                Publication date PMC-release: 10 July 2017
                Publication date Collection: 2017
                Volume: 18
                Electronic Location Identifier: 313
                Affiliations
                [1 ]ISNI 0000 0004 0477 2585, GRID grid.411095.8, Department of Anaesthesiology, , Hospital of the University of Munich LMU, ; Marchioninistr. 15, 81377 Munich, Germany
                [2 ]Department of Anaesthesiology, Surgical Clinic of Munich-Bogenhausen, Munich, Germany
                [3 ]Department of Gynaecology, Hospital of the University of Munich, LMU, Munich, Germany
                Author information
                http://orcid.org/0000-0003-3605-955X
                Article
                Publisher ID: 2051
                DOI: 10.1186/s13063-017-2051-z
                PMC ID: 5504754
                PubMed ID: 28693594
                SO-VID: a2a2c0a5-c01c-4da7-862f-f17721ad0bf6
                Copyright © © The Author(s). 2017
                License:

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                Date received : 1 July 2016
                Date accepted : 13 June 2017
                Funding
                Funded by: Fresenius Kabi (DE)
                Award ID: not applicable
                Categories
                Subject: Study Protocol
                Custom metadata
                issue-copyright-statement © The Author(s) 2017

                ScienceOpen disciplines: Medicine
                Keywords: phosphate,fluid replacement therapy,weak acids [a-],stewart concept,acid-base balance
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: phosphate, fluid replacement therapy, weak acids [a-], stewart concept, acid-base balance

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