Evidence map›Paper›PMID 34895290›Full record

ArticleTrials2021

Effects of immunoglobulin plus prednisolone in reducing coronary artery lesions in patients with Kawasaki disease: study protocol for a phase III multicenter, open-label, blinded-endpoints randomized controlled trial.

Si-Yuan Lin, Lan He, Li-Ping Xie, Yin Wang, Yi-Xiang Lin, Yin-Yin Cao, Wei-Li Yan, Fang Liu, Guo-Ying Huang

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04078568 (Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 35% 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.

NCT04078568 phase3completednot on this map

Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease: A Multicentre Randomised Controlled Trial

TypeinterventionalSponsorChildren's Hospital of Fudan UniversityRan2020 to 2025Enrolled3,208ConditionsKawasaki DiseaseArmsIVIG, Aspirin, Prednisolone
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Intravenous immunoglobulin for the treatment of Kawasaki disease.The Cochrane database of systematic reviews · 2023
    Pooled it
  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 1 institution in 1 country.

Si-Yuan Lin *Heart Center, Children's Hospital of Fudan University, Shanghai, 201102, China.
Lan He *Heart Center, Children's Hospital of Fudan University, Shanghai, 201102, China.
Li-Ping XieHeart Center, Children's Hospital of Fudan University, Shanghai, 201102, China.
Yin WangClinical Trial Unit, Children's Hospital of Fudan University, Shanghai, 201102, China.
Yi-Xiang LinHeart Center, Children's Hospital of Fudan University, Shanghai, 201102, China.
Yin-Yin CaoHeart Center, Children's Hospital of Fudan University, Shanghai, 201102, China.
Wei-Li YanClinical Trial Unit, Children's Hospital of Fudan University, Shanghai, 201102, China. yanwl@fudan.edu.cn.
Fang LiuHeart Center, Children's Hospital of Fudan University, Shanghai, 201102, China. liufang@fudan.edu.cn.ORCID http://orcid.org/0000-0003-4841-8206
Guo-Ying HuangHeart Center, Children's Hospital of Fudan University, Shanghai, 201102, China. gyhuang@shmu.edu.cn.
Children's Hospital of Fudan University · CN

Funding

Innovation Unit Project, Chinese Academy of Medical Sciences 2018RU002
6 · The paper itself

Abstract

backgroundKawasaki disease (KD) is an acute systemic vasculitis of unclear etiology that mainly affects infants and young children. Strategies to reduce the incidence and severity of coronary artery lesions (CALs), the determinant factor in the long-term prognosis of KD, are currently a focus of studies on KD. Corticosteroids, preferred in the treatment of the majority of vasculitides, are controversial in the treatment of acute KD. In this trial, we will evaluate whether the addition of prednisolone to standard intravenous immunoglobulin (IVIG) plus aspirin therapy can reduce the occurrence of CAL in Chinese patients with KD.

methodsThis is a multicenter, prospective, open-label, randomized controlled trial, which is expected to be conducted in more than 20 hospitals in China and aims to assess the efficacy and safety of IVIG + prednisolone treatment versus standard treatment. Patients with KD who fulfill the inclusion and exclusion criteria will be recruited and randomized (1:1) to receive either a large dose of IVIG (2 g/kg over 12-24 h with a maximum dose of 60 g) + aspirin 30 mg/kg/d or IVIG (2 g/kg over 12-24 h) + aspirin 30 mg/kg/d + prednisolone (2 mg/kg/d with a maximum dose of 60 mg tapered over 15 days after normalization of C-reactive protein concentration). The primary outcome will be the occurrence of CAL at 1 month of illness. The follow-up duration for each participant will be set as 1 year. Patients and treating physicians will be unmasked to group allocation. DISCUSSION: This will be the first multicenter randomized controlled trial to evaluate the efficacy of IVIG + aspirin + prednisolone in Chinese pediatric patients with KD, which may provide high-level evidence for improving the initial treatment for acute KD.

trial registrationClinicalTrials.gov NCT04078568 . Registered on 16 August 2018.

Indexed as

Mucocutaneous Lymph Node SyndromeChildChild, PreschoolClinical Trials, Phase III as TopicCoronary VesselsHumansImmunoglobulins, IntravenousInfantMulticenter Studies as TopicPrednisoloneProspective StudiesRandomized Controlled Trials as TopicImmunoglobulins, IntravenousPrednisoloneCoronary artery lesionsCorticosteroidKawasaki diseasePrimary treatment

Identifiers

PMID34895290
PMCPMC8665612
OpenAlexW4200223775

What OpenQuestion holds

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LicenceCC BY
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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.