Evidence map›Paper›PMID 31200756›Full record

ArticleTrials2019

Hypertonic saline for fluid resuscitation after cardiac surgery (HERACLES): study protocol for a preliminary randomised controlled clinical trial.

Carmen A Pfortmueller, Anna S Messmer, Benjamin Hess, David Reineke, Laura Jakob, Stefanie Wenger, Jan Waskowski, Patrick Zuercher, Frederik Stoehr, Gabor Erdoes and 4 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03280745 (Hypertonic Saline for Fluid Resuscitation After Cardiac 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
1.5field-weighted citation impact, top 18% 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.

NCT03280745 phase4completednot on this map

Hypertonic Saline for Fluid Resuscitation After Cardiac Surgery

TypeinterventionalSponsorInsel Gruppe AG, University Hospital BernRan2018 to 2019Enrolled165ConditionsCardiovascular Diseases, Valvular Heart DiseaseArmsHypertonic saline, 0.9% saline
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  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

14 authors at 1 institution in 1 country.

Carmen A PfortmuellerDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, CH-3010, Bern, Switzerland. Carmen.Pfortmueller@insel.ch.ORCID http://orcid.org/0000-0003-0326-2770
Anna S MessmerDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, CH-3010, Bern, Switzerland.
Benjamin HessDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, CH-3010, Bern, Switzerland.
David ReinekeDepartment of Cardiovascular Surgery, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Laura JakobDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, CH-3010, Bern, Switzerland.
Stefanie WengerDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, CH-3010, Bern, Switzerland.
Jan WaskowskiDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, CH-3010, Bern, Switzerland.
Patrick ZuercherDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, CH-3010, Bern, Switzerland.
Frederik StoehrDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, CH-3010, Bern, Switzerland.
Gabor ErdoesDepartment of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Markus M LuediDepartment of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Stephan M JakobDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, CH-3010, Bern, Switzerland.
Lars EnglbergerDepartment of Cardiovascular Surgery, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Joerg C SchefoldDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, CH-3010, Bern, Switzerland.
University of Bern · CH

Funding

B. Braun-Stiftung BBST-D-17-00069Novartis Stiftung für Medizinisch-Biologische Forschung 17C144Scherbarth Stiftung (CH) N/ASchweizerische Herzstiftung N/A
6 · The paper itself

Abstract

backgroundIntraoperative and postoperative management of cardiac surgery patients is complex, involving the application of differential vasopressors and volume therapy. It has been shown that a positive fluid balance has a major impact on postoperative outcome. Today, the advantages and disadvantages of buffered crystalloid solutes are a topic of controversy, with no consensus being reached so far. The use of hypertonic saline (HS) has shown promising results with respect to lower total fluid balance and postoperative weight gain in critically ill patients in preliminary studies. However, collection of more data on HS in critically ill patients seems warranted. This preliminary study aims to investigate whether fluid resuscitation using HS in patients following cardiac surgery results in less total fluid volume being administered.

methodsIn a prospective double-blind randomised controlled clinical trial, we aim to recruit 96 patients undergoing elective cardiac surgery for ischaemic and/or valvular heart disease. After postoperative admission to the intensive care unit (ICU), patients will be randomly assigned to receive 5 ml/kg ideal body weight HS (7.3% NaCl) or normal saline (NS, 0.9% NaCl) infused within 60 min. Blood and urine samples will be collected preoperatively and postoperatively up to day 6 to assess changes in renal, cardiac, inflammatory, acid-base, and electrolyte parameters. Additionally, we will perform renal ultrasonography studies to assess renal blood flow before, during, and after infusion, and we will measure total body water using preoperative and postoperative body composition analysis (bioimpedance). Patients will be followed up for 90 days. DISCUSSION: The key objective of this study is to assess the cumulative amount of fluid administered in the intervention (HS) group versus control (NS) group during the ICU stay. In this preliminary, prospective, randomised controlled clinical trial we will test the hypothesis that use of HS results in less total fluids infused and less postoperative weight gain when compared to the standard of intensive care in cardiac surgery patients.

trial registrationClinicalTrials.gov, NCT03280745 . Registered on 12 September 2017.

Indexed as

Cardiac Surgical ProceduresRandomized Controlled Trials as TopicDouble-Blind MethodFluid TherapyHeart Valve DiseasesHumansIntensive Care UnitsMyocardial IschemiaOutcome Assessment, Health CareProspective StudiesSaline Solution, HypertonicSaline Solution, HypertonicCardiac surgeryCardiosurgeryCritical illnessFluid balanceFluid resuscitationHypertonic salineICUIschaemic heart diseaseNormal salineValvular heart disease

Identifiers

PMID31200756
PMCPMC6570959
OpenAlexW2953179872

What OpenQuestion holds

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LicenceCC BY
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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.