Evidence map›Paper›PMID 25047825›Full record

Trial reportBMC nephrology2014

Rationale and design of the Myocardial Microinjury and Cardiac Remodeling Extension Study in the Sodium Lowering in Dialysate trial (Mac-SoLID study).

Joanna Leigh Dunlop, Alain Charles Vandal, Janak Rashme de Zoysa, Ruvin Sampath Gabriel, Lukas Mathias Gerber, Imad Adbi Haloob, Christopher John Hood, John Hamilton Irvine, Philip James Matheson, David Owen Ross McGregor and 4 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC nephrology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.2field-weighted citation impact, top 46% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 5 citations in OpenAlex.

  1. Low dialysate sodium levels for chronic haemodialysis.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Low dialysate sodium levels for chronic haemodialysis.The Cochrane database of systematic reviews · 2019
    Pooled it
  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 9 institutions in 1 country.

Joanna Leigh Dunlop
Alain Charles Vandal
Janak Rashme de Zoysa
Ruvin Sampath Gabriel
Lukas Mathias Gerber
Imad Adbi Haloob
Christopher John Hood
John Hamilton Irvine
Philip James Matheson
David Owen Ross McGregor
Kannaiyan Samuel Rabindranath
John Benedict William Schollum
David John Semple
Mark Roger MarshallFaculty of Medical and Health Sciences, University of Auckland, Private Bag 93311, Otahuhu, Auckland 1640, New Zealand. mrmarsh@woosh.co.nz.
University of Auckland · NZAuckland City Hospital · NZChristchurch Hospital · NZAuckland University of Technology · NZDunedin Public Hospital · NZMiddlemore Hospital · NZNorth Shore Hospital · NZWaikato Hospital · NZWellington Hospital · NZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Sodium Lowering in Dialysate (SoLID) trial is an ongoing a multi-center, prospective, randomised, single-blind (assessor), controlled, parallel assignment clinical trial, enrolling 96 home and self-care hemodialysis (HD) patients from 7 centers in New Zealand. The trial will evaluate the hypothesis that lower dialysate [Na+] during HD results in lower left ventricular (LV) mass. Since it's inception, observational evidence has suggested increased mortality risk with lower dialysate [Na+], possibly due to exacerbation of intra-dialytic hypotension and subsequent myocardial micro-injury. The Myocardial Micro-injury and Cardiac Remodeling Extension Study in the Sodium Lowering In Dialysate Trial (Mac-SoLID study) aims to determine whether lower dialysate [Na+] results in (i) increased levels of high-sensitivity Troponin T (hsTnT), a well-established marker of intra-dialytic myocardial micro-injury in HD populations, and (ii) increased fixed LV segmental wall motion abnormalities, a marker of recurrent myocardial stunning and micro-injury, and (iii) detrimental changes in LV geometry due to maladaptive homeostatic mechanisms. METHODS/

designThe SoLID trial and the Mac-SoLID study are funded by the Health Research Council of New Zealand. Key exclusion criteria: patients who dialyse > 3.5 times per week, pre-dialysis serum sodium <135 mM, and maintenance haemodiafiltration. In addition, some medical conditions, treatments or participation in other dialysis trials that contraindicate the study intervention or confound its effects, will be exclusion criteria. The intervention and control groups will receive dialysate sodium 135 mM and 140 mM respectively, for 12 months. The primary outcome measure for the Mac-SOLID study is repeated measures of [hsTnT] at 0, 3, 6, 9, and 12 months. The secondary outcomes will be assessed using cardiac magnetic resonance imaging (MRI), and comprise LV segmental wall motion abnormality scores, LV mass to volume ratio and patterns of LV remodeling at 0 and 12 months. DISCUSSION: The Mac-SoLID study enhances and complements the SoLID trial. It tests whether potential gains in cardiovascular health (reduced LV mass) which low dialysate [Na+] is expected to deliver, are counteracted by deterioration in cardiovascular health through alternative mechanisms, namely repeated LV stunning and micro-injury.

trial registrationAustralian and New Zealand Clinical Trials Registry number: ACTRN12611000975998.

Indexed as

Coronary VesselsDialysis SolutionsFemaleHumansMaleMicrocirculationNew ZealandProspective StudiesRenal DialysisSelf CareSingle-Blind MethodSodiumVentricular RemodelingDialysis SolutionsSodium

Identifiers

PMID25047825
PMCPMC4114800
OpenAlexW2097141494

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.