Impact of a new balanced gelatine on electrolytes and pH in the perioperative care
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...
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| creator | Marx, Gernot Meybohm, Patrick Schuerholz, Tobias Lotz, Gösta Ledinko, Mandy Schindler, Achim W Rossaint, Rolf Zacharowski, Kai |
| description | 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.
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) |
| doi_str_mv | 10.1371/journal.pone.0213057 |
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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.
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.
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.
ClinicalTrials.gov (NCT01515397) and clinicaltrialsregister.eu, EudraCT number 2010-018524-58.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0213057</identifier><identifier>PMID: 31034525</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Abdomen ; Abdomen - physiopathology ; Abdomen - surgery ; Abdominal surgery ; Acid-Base Imbalance - drug therapy ; Acid-Base Imbalance - physiopathology ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Analysis ; Anesthesiology ; Blood ; Blood pressure ; Body weight ; Chloride ; Chlorides - blood ; Clinical trials ; Coagulation ; Control ; Electrolytes ; Electrolytes - administration & dosage ; Female ; Fluid Therapy ; Fluid-electrolyte imbalance ; Gelatin - administration & dosage ; Gelatin capsules ; Germany ; Hemodynamics ; Hospital patients ; Hospitals ; Humans ; Hydrogen-Ion Concentration ; Hydroxyethyl Starch Derivatives - administration & dosage ; Infusion ; Intensive care ; Kidney failure ; Kidneys ; Male ; Management ; Mathematical analysis ; Medicine ; Metabolism ; Middle Aged ; Pain ; Patients ; Perioperative Care ; Plasma Substitutes - administration & dosage ; Renal failure ; Renal function ; Risk factors ; Sodium chloride ; Surgery ; Systematic review ; Vasoactive agents ; Venous pressure ; Water-Electrolyte Balance - drug effects ; Water-Electrolyte Imbalance - drug therapy ; Water-Electrolyte Imbalance - physiopathology ; Young Adult</subject><ispartof>PloS one, 2019-04, Vol.14 (4), p.e0213057-e0213057</ispartof><rights>COPYRIGHT 2019 Public Library of Science</rights><rights>2019 Marx et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2019 Marx et al 2019 Marx et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-eeb403aa70b143074feff6e45b31973aed13b932a82c0ab943f73857697e4ce73</citedby><cites>FETCH-LOGICAL-c692t-eeb403aa70b143074feff6e45b31973aed13b932a82c0ab943f73857697e4ce73</cites><orcidid>0000-0002-0212-9110 ; 0000-0003-0866-4234</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6488052/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6488052/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,2915,23845,27901,27902,53766,53768,79342,79343</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31034525$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Marx, Gernot</creatorcontrib><creatorcontrib>Meybohm, Patrick</creatorcontrib><creatorcontrib>Schuerholz, Tobias</creatorcontrib><creatorcontrib>Lotz, Gösta</creatorcontrib><creatorcontrib>Ledinko, Mandy</creatorcontrib><creatorcontrib>Schindler, Achim W</creatorcontrib><creatorcontrib>Rossaint, Rolf</creatorcontrib><creatorcontrib>Zacharowski, Kai</creatorcontrib><title>Impact of a new balanced gelatine on electrolytes and pH in the perioperative care</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>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.
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.
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.
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.
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administration & dosage</subject><subject>Infusion</subject><subject>Intensive care</subject><subject>Kidney failure</subject><subject>Kidneys</subject><subject>Male</subject><subject>Management</subject><subject>Mathematical analysis</subject><subject>Medicine</subject><subject>Metabolism</subject><subject>Middle Aged</subject><subject>Pain</subject><subject>Patients</subject><subject>Perioperative Care</subject><subject>Plasma Substitutes - administration & dosage</subject><subject>Renal failure</subject><subject>Renal function</subject><subject>Risk factors</subject><subject>Sodium chloride</subject><subject>Surgery</subject><subject>Systematic review</subject><subject>Vasoactive agents</subject><subject>Venous pressure</subject><subject>Water-Electrolyte Balance - drug effects</subject><subject>Water-Electrolyte Imbalance - drug therapy</subject><subject>Water-Electrolyte Imbalance - physiopathology</subject><subject>Young Adult</subject><issn>1932-6203</issn><issn>1932-6203</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><sourceid>DOA</sourceid><recordid>eNqNkl1rFDEUhgdRbK3-A9GAIHqxa75mMnMjlKJ2oVCoH7fhTObMbkp2Mk4y1f57s-607EgvJJCE5DnvyTl5s-wlo0smFPtw7cehA7fsfYdLypmguXqUHbNK8EXBqXh8sD_KnoVwTWkuyqJ4mh0JRoXMeX6cXa22PZhIfEuAdPiL1OCgM9iQNTqItkPiO4IOTRy8u40YCHQN6c-J7UjcIOlxsD5Nib1BYmDA59mTFlzAF9N6kn3__Onb2fni4vLL6uz0YmGKiscFYi2pAFC0ZlJQJVts2wJlXgtWKQHYMFGnAqDkhkJdSdEqUeaqqBRKg0qcZK_3ur3zQU_tCJpzpmjFy7JIxGpPNB6udT_YLQy32oPVfw_8sNYwRGscamBcmILxqlKFNCWWecFQtVArkzccdlofp2xjvcXGYBcHcDPR-U1nN3rtb3Qhy5LmPAm8mwQG_3PEEPXWBoMutRv9uH-3LCWVVULf_IM-XN1ErSEVYLvWp7xmJ6pP81JUOS8qkajlA1QaDW6tSd5pbTqfBbyfBSQm4u-4hjEEvfp69f_s5Y85-_aA3SC4uAnejdH6LsxBuQfN4EMYsL1vMqN6Z_27buid9fVk_RT26vCD7oPuvC7-AHUb_PE</recordid><startdate>20190429</startdate><enddate>20190429</enddate><creator>Marx, Gernot</creator><creator>Meybohm, Patrick</creator><creator>Schuerholz, Tobias</creator><creator>Lotz, Gösta</creator><creator>Ledinko, Mandy</creator><creator>Schindler, Achim W</creator><creator>Rossaint, Rolf</creator><creator>Zacharowski, Kai</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>IOV</scope><scope>ISR</scope><scope>3V.</scope><scope>7QG</scope><scope>7QL</scope><scope>7QO</scope><scope>7RV</scope><scope>7SN</scope><scope>7SS</scope><scope>7T5</scope><scope>7TG</scope><scope>7TM</scope><scope>7U9</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABJCF</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>D1I</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB.</scope><scope>KB0</scope><scope>KL.</scope><scope>L6V</scope><scope>LK8</scope><scope>M0K</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>M7S</scope><scope>NAPCQ</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PATMY</scope><scope>PDBOC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PTHSS</scope><scope>PYCSY</scope><scope>RC3</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0002-0212-9110</orcidid><orcidid>https://orcid.org/0000-0003-0866-4234</orcidid></search><sort><creationdate>20190429</creationdate><title>Impact of a new balanced gelatine on electrolytes and pH in the perioperative care</title><author>Marx, Gernot ; Meybohm, Patrick ; Schuerholz, Tobias ; Lotz, Gösta ; Ledinko, Mandy ; Schindler, Achim W ; Rossaint, Rolf ; Zacharowski, Kai</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c692t-eeb403aa70b143074feff6e45b31973aed13b932a82c0ab943f73857697e4ce73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Abdomen</topic><topic>Abdomen - 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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Marx, Gernot</au><au>Meybohm, Patrick</au><au>Schuerholz, Tobias</au><au>Lotz, Gösta</au><au>Ledinko, Mandy</au><au>Schindler, Achim W</au><au>Rossaint, Rolf</au><au>Zacharowski, Kai</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Impact of a new balanced gelatine on electrolytes and pH in the perioperative care</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2019-04-29</date><risdate>2019</risdate><volume>14</volume><issue>4</issue><spage>e0213057</spage><epage>e0213057</epage><pages>e0213057-e0213057</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>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.
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.
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.
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.
ClinicalTrials.gov (NCT01515397) and clinicaltrialsregister.eu, EudraCT number 2010-018524-58.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>31034525</pmid><doi>10.1371/journal.pone.0213057</doi><tpages>e0213057</tpages><orcidid>https://orcid.org/0000-0002-0212-9110</orcidid><orcidid>https://orcid.org/0000-0003-0866-4234</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2019-04, Vol.14 (4), p.e0213057-e0213057 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_2217092886 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; Free Full-Text Journals in Chemistry; Public Library of Science (PLoS) |
| subjects | Abdomen Abdomen - physiopathology Abdomen - surgery Abdominal surgery Acid-Base Imbalance - drug therapy Acid-Base Imbalance - physiopathology Adolescent Adult Aged Aged, 80 and over Analysis Anesthesiology Blood Blood pressure Body weight Chloride Chlorides - blood Clinical trials Coagulation Control Electrolytes Electrolytes - administration & dosage Female Fluid Therapy Fluid-electrolyte imbalance Gelatin - administration & dosage Gelatin capsules Germany Hemodynamics Hospital patients Hospitals Humans Hydrogen-Ion Concentration Hydroxyethyl Starch Derivatives - administration & dosage Infusion Intensive care Kidney failure Kidneys Male Management Mathematical analysis Medicine Metabolism Middle Aged Pain Patients Perioperative Care Plasma Substitutes - administration & dosage Renal failure Renal function Risk factors Sodium chloride Surgery Systematic review Vasoactive agents Venous pressure Water-Electrolyte Balance - drug effects Water-Electrolyte Imbalance - drug therapy Water-Electrolyte Imbalance - physiopathology Young Adult |
| title | Impact of a new balanced gelatine on electrolytes and pH in the perioperative care |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-12T16%3A47%3A50IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Impact%20of%20a%20new%20balanced%20gelatine%20on%20electrolytes%20and%20pH%20in%20the%20perioperative%20care&rft.jtitle=PloS%20one&rft.au=Marx,%20Gernot&rft.date=2019-04-29&rft.volume=14&rft.issue=4&rft.spage=e0213057&rft.epage=e0213057&rft.pages=e0213057-e0213057&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0213057&rft_dat=%3Cgale_plos_%3EA583952693%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2217092886&rft_id=info:pmid/31034525&rft_galeid=A583952693&rft_doaj_id=oai_doaj_org_article_a123c61299764c8e8561e7fab7c5d2a6&rfr_iscdi=true |