Evidence map›Paper›PMID 34217297›Full record

Trial reportPediatric rheumatology online journal2021

Efficacy and safety associated with the infusion speed of intravenous immunoglobulin for the treatment of Kawasaki disease: a randomized controlled trial.

Saori Fukui, Mitsuru Seki, Takaomi Minami, Kazuhiko Kotani, Kensuke Oka, Akiko Yokomizo, Daisuke Matsubara, Tomoyuki Sato, Yasuyuki Nozaki, Mari Saito and 4 more

Open access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Pediatric rheumatology online journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 12% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Intravenous immunoglobulin for the treatment of Kawasaki disease.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Trial
  3. Intravenous non-specific immunoglobulins as adjunctive therapy for invasiveRevista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2026
    Observational
  4. Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. 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

14 authors at 3 institutions in 1 country.

Saori FukuiDepartment of Pediatrics, Jichi Medical University, 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan.
Mitsuru SekiDepartment of Pediatrics, Jichi Medical University, 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan. m-seki@jichi.ac.jp.ORCID http://orcid.org/0000-0003-3293-9330
Takaomi MinamiDepartment of Pediatrics, Jichi Medical University, 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan.
Kazuhiko KotaniDivision of Community and Family Medicine, Jichi Medical University, Tochigi, Japan.
Kensuke OkaDepartment of Pediatrics, Jichi Medical University, 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan.
Akiko YokomizoDepartment of Pediatrics, Jichi Medical University, 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan.
Daisuke MatsubaraDepartment of Pediatrics, Jichi Medical University, 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan.
Tomoyuki SatoDepartment of Pediatrics, Jichi Medical University, 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan.
Yasuyuki NozakiDepartment of Pediatrics, Shin-Oyama City Hospital, Tochigi, Japan.
Mari SaitoDepartment of Pediatrics, Haga Red-Cross Hospital, Tochigi, Japan.
Yutaka KikuchiDepartment of Pediatrics, Haga Red-Cross Hospital, Tochigi, Japan.
Kenji MiyamotoDepartment of Pediatrics, Dokkyo Medical University, Tochigi, Japan.
Yukifumi MondenDepartment of Pediatrics, Jichi Medical University, 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan.
Takanori YamagataDepartment of Pediatrics, Jichi Medical University, 3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan.
Jichi Medical University · JPAshikaga Red Cross Hospital · JPDokkyo Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHigh-dose intravenous immunoglobulin (IVIG) is the mainstay of treatment for Kawasaki disease (KD). Usually, 2 g/kg of IVIG is administered over 10-24 h, depending on the institution or physician, but the association between infusion speed and effectiveness has not been reported. In this study, we evaluated the differences in efficacy and safety between two different IVIG administration speeds.

methodsThis was a multicenter, unblinded, randomized controlled study. Patients newly diagnosed with KD were randomized into two groups: one who received IVIG over 12 h (12H group, double speed), and one that received IVIG over 24 h (24H group, reference speed). The endpoints included the duration of fever, incidence of coronary artery abnormalities (CAAs) and of adverse events. Laboratory data were evaluated before and after IVIG administration.

resultsA total of 39 patients were enrolled. There was no difference between groups in fever duration after the initiation of IVIG (21 h vs. 21.5 h, p = 0.325), and no patient experienced CAAs. Two adverse events were observed in the 12H group (elevation of aspartate aminotransferase and vomiting), however no severe adverse events requiring treatments or extension of hospital stay were observed in either group. After initial IVIG administration, the change ratio of inflammatory markers, such as white blood cell counts, neutrophils, C-reactive protein, and albumin, did not show significant differences between the two groups. On the other hand, a greater increase of serum immunoglobulin G from its baseline level was observed in the 24H group compared to the 12H group (3037 ± 648 mg/dl vs. 2414 ± 248 mg/dl, p < 0.01).

conclusionThe efficacy and safety of IVIG administered over 12 h (double speed) were similar to those administered over 24 h (reference speed).

trial registrationUniversity Hospital Medical Information Network ( UMIN000014665 ). Registered 27 July 2014 - Prospectively registered, https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000017058.

Indexed as

ChildChild, PreschoolFemaleHumansImmunoglobulins, IntravenousImmunologic FactorsInfantInfusions, IntravenousMaleMucocutaneous Lymph Node SyndromeTime FactorsTreatment OutcomeImmunoglobulins, IntravenousImmunologic FactorsEffectivenessIntravenous immunoglobulinIVIGKawasaki diseaseRandomized studySafety

Identifiers

PMID34217297
PMCPMC8254926
OpenAlexW3180837064

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.