Evidence map›Paper›PMID 32321450›Full record

ArticleBMC nephrology2020

Reno-protective effects of oral alkalizing agents in chronic kidney disease with aciduria: protocol for a randomized cohort study.

Michiaki Abe, Tetsuya Akaishi, Mutsumi Shoji, Takuhiro Yamaguchi, Takashi Miki, Fumitoshi Satoh, Shin Takayama, Satomi Yamasaki, Kazuhiko Kawaguchi, Hiroshi Sato and 3 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC nephrology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 44% 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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. 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

13 authors at 3 institutions in 1 country.

Michiaki AbeDepartment of Education and Support for Regional Medicine, Tohoku University Hospital, Sendai, Miyagi, Japan. michiabe@med.tohoku.ac.jp.
Tetsuya AkaishiDepartment of Education and Support for Regional Medicine, Tohoku University Hospital, Sendai, Miyagi, Japan.
Mutsumi ShojiDepartment of Education and Support for Regional Medicine, Tohoku University Hospital, Sendai, Miyagi, Japan.
Takuhiro YamaguchiClinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai, Miyagi, Japan.
Takashi MikiClinical Physiology Center, Tohoku University Hospital, Sendai, Miyagi, Japan.
Fumitoshi SatohDivision of Nephrology, Endocrinology and Vascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.
Shin TakayamaDepartment of Education and Support for Regional Medicine, Tohoku University Hospital, Sendai, Miyagi, Japan.
Satomi YamasakiMedical Affairs Department, Nippon Chemiphar Co., Ltd., Tokyo, Japan.
Kazuhiko KawaguchiMedical Affairs Department, Nippon Chemiphar Co., Ltd., Tokyo, Japan.
Hiroshi SatoDivision of Nephrology, Endocrinology and Vascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.
Tadashi IshiiDepartment of Education and Support for Regional Medicine, Tohoku University Hospital, Sendai, Miyagi, Japan.
Sadayoshi ItoDivision of Nephrology, Endocrinology and Vascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.
CKOALA study group
Tohoku University · JPTohoku University Hospital · JPNippon Chemiphar (Japan) · JP

Funding

Grant-in-Aid for Scientific Research (C) KAKENHI 16K08487Nippon Chemiphar Co., Ldt. Cooperating research funding
6 · The paper itself

Abstract

backgroundAciduria caused by urinary excretion of acidic metabolic wastes produced in daily life is known to be augmented in patients with chronic kidney disease (CKD). To evaluate the reno-protective effect of oral alkalizing agents for the improvement of metabolic acidosis and neutralization of intratubular pH in the patients with mild stages of CKD. Also, to identify reno-protective surrogate markers in the serum and urine that can closely associate the effect of urine alkalization.

methodsIn this single-centered, open-labeled, randomized cohort study, patients with CKD stages G2, G3a and G3b, who visited and were treated at Tohoku University Hospital during the enrollment period were registered. We administered sodium bicarbonate or sodium-potassium citrate as the oral alkalinizing agents. A total of 150 patients with CKD will be randomly allocated into the following three groups: sodium bicarbonate, sodium-potassium citrate and standard therapy group without any alkalinizing agents. The data of performance status, venous blood test, spot urine test, venous blood-gas test, electrocardiogram, renal arterial ultrasonography and chest X-ray will be collected at 0, 6, 12 and 24 weeks (short-term study) from starting the interventions. These data will be also collected at 1 and 2 years (long-term study). The samples of plasma and serum and early-morning urine at every visit will be acquired for the analysis of renal function and surrogate uremic biomarkers. The recruitment for this cohort study terminated in March, 2018, and the follow-up period for all the enrolled subjects will be terminated in December, 2020. The primary endpoint will be the development of originally-defined significant renal dysfunction or the occurrence of any cerebrovascular disease in the short-term study. The secondary endpoint will be the same endpoints as in the long-term study, or the patients with significant changes in the suggested the surrogate biomarkers. DISCUSSION: The findings of this study will address the importance of taking oral alkalizing agents in the patients with early stages of CKD, furthermore they could address any new surrogate biomarkers that can be useful from early stage CKD.

trial registrationRegistered Report Identifier: UMIN000010059 and jRCT021180043. The trial registration number; 150. Date of registration; 2013/02/26.

Indexed as

AcidosisRenal Insufficiency, ChronicAdministration, OralAdultAntacidsBiomarkersDrug MonitoringFemaleHumansMalePotassium CitrateProtective AgentsRandomized Controlled Trials as TopicRenal EliminationSodium BicarbonateSodium CitrateAntacidsBiomarkersPotassium CitrateProtective AgentsSodium BicarbonateSodium CitrateBicarbonateChronic kidney diseaseCitrateOral alkalizing agentsSingle-centered and randomized cohort study

Identifiers

PMID32321450
PMCPMC7178750
OpenAlexW3018029183

What OpenQuestion holds

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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.