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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Judith-Irina Pagel, Nikolai Hulde, Tobias Kammerer, Michaela Schwarz, Daniel Chappell, Alexander Burges, Klaus Hofmann-Kiefer, Markus Rehm

Published in: Trials | Issue 1/2017

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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.
Appendix
Available only for authorised users
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Metadata
Title
The impact of phosphate-balanced crystalloid infusion on acid-base homeostasis (PALANCE study): study protocol for a randomized controlled trial
Authors
Judith-Irina Pagel
Nikolai Hulde
Tobias Kammerer
Michaela Schwarz
Daniel Chappell
Alexander Burges
Klaus Hofmann-Kiefer
Markus Rehm
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2051-z

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