Evidence map›Paper›PMID 31034525›Full record

Trial reportPloS one2019

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

Gernot Marx, Patrick Meybohm, Tobias Schuerholz, Gösta Lotz, Mandy Ledinko, Achim W Schindler, Rolf Rossaint, Kai Zacharowski

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01515397 (Efficacy and Safety of a Balanced Gelatine Solution in Combination With a Balanced Electrolyte Solution Versus a Standard Gelatine Solution in Combination With a Non-balanced Electrolyte Solution in Patients Scheduled for Abdominal Surgery), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.4field-weighted citation impact, top 38% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01515397 phase3completednot on this map

Efficacy and Safety of a Balanced Gelatine Solution in Combination With a Balanced Electrolyte Solution Versus a Standard Gelatine Solution in Combination With a Non-balanced Electrolyte Solution in Patients Scheduled for Abdominal Surgery

TypeinterventionalSponsorB. Braun Melsungen AGRan2011 to 2013Enrolled40ConditionsHypovolemiaArmsGelofusine balanced, Gelofusine 4%
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Gernot MarxDepartment of Intensive Care Medicine and Intermediate Care, University Hospital RWTH Aachen, Medical Faculty RWTH Aachen University, Aachen, Germany.ORCID 0000-0003-0866-4234
Patrick MeybohmDepartment of Anesthesiology, Intensive Care Medfiicine & Pain Therapy, University Hospital Frankfurt, Frankfurt, Germany.
Tobias SchuerholzDepartment of Intensive Care Medicine and Intermediate Care, University Hospital RWTH Aachen, Medical Faculty RWTH Aachen University, Aachen, Germany.
Gösta LotzDepartment of Anesthesiology, Intensive Care Medfiicine & Pain Therapy, University Hospital Frankfurt, Frankfurt, Germany.
Mandy LedinkoDepartment of Intensive Care Medicine and Intermediate Care, University Hospital RWTH Aachen, Medical Faculty RWTH Aachen University, Aachen, Germany.
Achim W SchindlerDepartment of Intensive Care Medicine and Intermediate Care, University Hospital RWTH Aachen, Medical Faculty RWTH Aachen University, Aachen, Germany.
Rolf RossaintDepartment of Anesthesiology, University Hospital RWTH Aachen, Medical Faculty RWTH University Aachen, Aachen, Germany.
Kai ZacharowskiDepartment of Anesthesiology, Intensive Care Medfiicine & Pain Therapy, University Hospital Frankfurt, Frankfurt, Germany.ORCID 0000-0002-0212-9110
RWTH Aachen University · DEGoethe University Frankfurt · DEUniversity of Rostock · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBalanced 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

methods40 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.

resultsThe 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 registrationClinicalTrials.gov (NCT01515397) and clinicaltrialsregister.eu, EudraCT number 2010-018524-58.

Indexed as

Perioperative CareAbdomenAcid-Base ImbalanceAdolescentAdultAgedAged, 80 and overChloridesElectrolytesFemaleFluid TherapyGelatinGermanyHumansHydrogen-Ion ConcentrationHydroxyethyl Starch DerivativesChloridesElectrolytesGelatinHydroxyethyl Starch DerivativesPlasma Substitutes

Identifiers

PMID31034525
PMCPMC6488052
OpenAlexW2943613427

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.