Evidence map›Paper›PMID 26030651›Full record

Trial reportPloS one2015

Short and Long-Term Effects of the Angiotensin II Receptor Blocker Irbesartan on Intradialytic Central Hemodynamics: A Randomized Double-Blind Placebo-Controlled One-Year Intervention Trial (the SAFIR Study).

Christian Daugaard Peters, Krista Dybtved Kjaergaard, Jens Dam Jensen, Kent Lodberg Christensen, Charlotte Strandhave, Ida Noerager Tietze, Marija Kristina Novosel, Bo Martin Bibby, Bente Jespersen

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00791830 (Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan - a Double Blind Randomised Study), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 33% 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.

NCT00791830 phase3completednot on this map

Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan - a Double Blind Randomised Study

TypeinterventionalSponsorUniversity of AarhusRan2009 to 2013Enrolled82ConditionsKidney Failure, ChronicArmsIrbesartan, Placebo matching irbesartan 150 mg
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Article
  3. 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

9 authors at 4 institutions in 1 country.

Christian Daugaard PetersDepartment of Renal Medicine, Aarhus University Hospital, Aarhus, Denmark; Institute of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Krista Dybtved KjaergaardDepartment of Renal Medicine, Aarhus University Hospital, Aarhus, Denmark; Institute of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Jens Dam JensenDepartment of Renal Medicine, Aarhus University Hospital, Aarhus, Denmark; Institute of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Kent Lodberg ChristensenDepartment of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
Charlotte StrandhaveDepartment of Nephrology, Aalborg University Hospital, Aalborg, Denmark.
Ida Noerager TietzeDepartment of Medicine, Viborg Regional Hospital, Viborg, Denmark.
Marija Kristina NovoselDepartment of Medicine, Fredericia Hospital, Fredericia, Denmark.
Bo Martin BibbyDepartment of Biostatistics, Aarhus University, Aarhus, Denmark.
Bente JespersenDepartment of Renal Medicine, Aarhus University Hospital, Aarhus, Denmark; Institute of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Aarhus University · DKAarhus University Hospital · DKAalborg University Hospital · DKRegionshospitalet Viborg · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimLittle is known about the tolerability of antihypertensive drugs during hemodialysis treatment. The present study evaluated the use of the angiotensin II receptor blocker (ARB) irbesartan.

designRandomized, double-blind, placebo-controlled, one-year intervention trial. SETTING AND

participantsEighty-two hemodialysis patients with urine output >300 mL/day and dialysis vintage <1 year.

interventionIrbesartan/placebo 300 mg/day for 12 months administered as add-on to antihypertensive treatment using a predialytic systolic blood pressure target of 140 mmHg in all patients. OUTCOMES AND MEASUREMENTS: Cardiac output, stroke volume, central blood volume, total peripheral resistance, mean arterial blood pressure, and frequency of intradialytic hypotension.

resultsAt baseline, the groups were similar regarding age, comorbidity, blood pressure, antihypertensive medication, ultrafiltration volume, and dialysis parameters. Over the one-year period, predialytic systolic blood pressure decreased significantly, but similarly in both groups. Mean start and mean end cardiac output, stroke volume, total peripheral resistance, heart rate, and mean arterial pressure were stable and similar in the two groups, whereas central blood volume increased slightly but similarly over time. The mean hemodynamic response observed during a dialysis session was a drop in cardiac output, in stroke volume, in mean arterial pressure, and in central blood volume, whereas heart rate increased. Total peripheral resistance did not change significantly. Overall, this pattern remained stable over time in both groups and was uninfluenced by ARB treatment. The total number of intradialytic hypotensive episodes was (placebo/ARB) 50/63 (P = 0.4). Ultrafiltration volume, left ventricular mass index, plasma albumin, and change in intradialytic total peripheral resistance were significantly associated with intradialytic hypotension in a multivariate logistic regression analysis based on baseline parameters.

conclusionUse of the ARB irbesartan as an add-on to other antihypertensive therapy did not significantly affect intradialytic hemodynamics, neither in short nor long-term, and no significant increase in hypotensive episodes was seen.

trial registrationClinicaltrials.gov NCT00791830.

Indexed as

Renal DialysisAngiotensin Receptor AntagonistsAntihypertensive AgentsBiphenyl CompoundsBlood PressureDouble-Blind MethodFemaleHemodynamicsHumansHypotensionIrbesartanLogistic ModelsMaleMiddle AgedMultivariate AnalysisPlacebosAngiotensin Receptor AntagonistsAntihypertensive AgentsBiphenyl CompoundsIrbesartanPlacebosReceptor, Angiotensin, Type 2Tetrazoles

Identifiers

PMID26030651
PMCPMC4452642
OpenAlexW568811952

What OpenQuestion holds

Textmetadata
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.