Evidence map›Paper›PMID 29420536›Full record

Trial reportPloS one2018

Randomized trial of one-hour sodium bicarbonate vs standard periprocedural saline hydration in chronic kidney disease patients undergoing cardiovascular contrast procedures.

Judith Kooiman, Jean-Paul P M de Vries, Jan Van der Heyden, Yvo W J Sijpkens, Paul R M van Dijkman, Jan J Wever, Hans van Overhagen, Antonie C Vahl, Nico Aarts, Iris J A M Verberk-Jonkers and 9 more

Open access · goldAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 26% 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, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
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

19 authors at 7 institutions in 1 country.

Judith KooimanDepartment of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.ORCID 0000-0002-0556-9234
Jean-Paul P M de VriesDepartment of Vascular Surgery, St. Antonius Hospital, Nieuwegein, the Netherlands.
Jan Van der HeydenDepartment of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands.
Yvo W J SijpkensDepartment of Internal Medicine, Bronovo Hospital, The Hague, the Netherlands.
Paul R M van DijkmanDepartment of Cardiology, Bronovo Hospital, the Hague, the Netherlands.
Jan J WeverDepartment of Vascular Surgery, Haga Teaching Hospital, The Hague, the Netherlands.
Hans van OverhagenDepartment of Radiology, Haga Teaching Hospital, The Hague, the Netherlands.
Antonie C VahlDepartment of Vascular Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.
Nico AartsDepartment of Radiology, Bronovo Hospital, The Hague, the Netherlands.
Iris J A M Verberk-JonkersDepartment of Nephrology, Maasstad Hospital, Rotterdam, the Netherlands.
Harald F H BrulezDepartment of Nephrology, St. Lucas Andreas Hospital, Amsterdam, the Netherlands.
Jaap F HammingDepartment of Vascular Surgery, Leiden University Medical Center, Leiden, the Netherlands.
Aart J van der MolenDepartment of Radiology, Leiden University Medical Center, Leiden, the Netherlands.
Suzanne C CannegieterDepartment of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands.
Hein PutterDepartment of Medical Statistics, Leiden University Medical Center, Leiden, the Netherlands.
Wilbert B van den HoutDepartment of Medical Decision Making, Leiden University Medical Center, Leiden, the Netherlands.
Inci KilicsoyDepartment of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.
Ton J RabelinkDepartment of Nephrology, Leiden University Medical Center, Leiden, The Netherlands.
Menno V HuismanDepartment of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.
Leiden University Medical Center · NLBronovo Hospital · NLHaga Hospital · NLSt. Antonius Ziekenhuis · NLMaasstad Ziekenhuis · NLOLVG · NLSint Lucas Andreas Hospital · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGuidelines advise periprocedural saline hydration for prevention of contrast induced-acute kidney injury (CI-AKI). We analysed whether 1-hour sodium bicarbonate hydration administered solely prior to intra-arterial contrast exposure is non-inferior to standard periprocedural saline hydration in chronic kidney disease (CKD) patients undergoing elective cardiovascular diagnostic or interventional contrast procedures.

methodsWe performed an open-label multicentre non-inferiority trial between 2011-2014. Patients were randomized to 1 hour pre-procedure sodium bicarbonate hydration (250 ml 1.4%, N = 168) or 4-12 hours saline hydration (1000 ml 0.9%, N = 165) prior to and following contrast administration (2000 ml of saline total). Primary outcome was the relative serum creatinine increase (%) 48-96 hours post contrast exposure. Secondary outcomes were: incidence of CI-AKI (serum creatinine increase>25% or >44μmol/L), recovery of renal function, the need for dialysis, and hospital costs within two months follow-up.

resultsMean relative creatinine increase was 3.1% (95%CI 0.9 to 5.2%) in the bicarbonate and 1.1% (95%CI -1.2 to 3.5%) in the saline arm, mean difference 1.9% (95%CI -1.2 to 5.1%, p-non-inferiority <0.001). CI-AKI occurred in 11 (6.7%) patients randomized to sodium bicarbonate and 12 (7.5%) to saline (p = 0.79). Renal function did not fully recover in 40.0% and 44.4% of CI-AKI patients, respectively (p = 0.84). No patient required dialysis. Mean costs for preventive hydration and clinical preparation for the contrast procedure were $1158 for sodium bicarbonate vs. $1561 for saline (p < 0.001).

conclusionShort hydration with sodium bicarbonate prior to elective cardiovascular diagnostic or therapeutic contrast procedures is non-inferior to standard periprocedural saline hydration in CKD patients with respect to renal safety and results in considerable healthcare savings.

trial registrationNetherlands Trial Register (http://www.trialregister.nl/trialreg/index.asp), Nr NTR2699.

Indexed as

Acute Kidney InjuryAgedAged, 80 and overCardiovascular SystemContrast MediaFemaleHumansKidney Failure, ChronicMaleMiddle AgedSodium BicarbonateSodium ChlorideContrast MediaSodium BicarbonateSodium Chloride

Identifiers

PMID29420536
PMCPMC5805164
OpenAlexW2793452983

What Socratic 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 Socratic graph.