Intravenous Rehydration for Severe Acute Malnutrition with Gastroenteritis.

IF 96.2 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Kathryn Maitland, San Maurice Ouattara, Hadiza Sainna, Abdullahi Chara, Oluwakemi F Ogundipe, Temmy Sunyoto, M Hamaluba, Peter Olupot-Olupot, Florence Alaroker, Roisin Connon, Amadou Saidou Maguina, William Okiror, Denis Amorut, Eric Mwajombo, Emmanuel Oguda, Christabel Mogaka, Céline Langendorf, Juan Emmanuel Dewez, Iza Ciglenecki, Diana M Gibb, Matthew E Coldiron, Roberta Petrucci, Elizabeth C George
{"title":"Intravenous Rehydration for Severe Acute Malnutrition with Gastroenteritis.","authors":"Kathryn Maitland, San Maurice Ouattara, Hadiza Sainna, Abdullahi Chara, Oluwakemi F Ogundipe, Temmy Sunyoto, M Hamaluba, Peter Olupot-Olupot, Florence Alaroker, Roisin Connon, Amadou Saidou Maguina, William Okiror, Denis Amorut, Eric Mwajombo, Emmanuel Oguda, Christabel Mogaka, Céline Langendorf, Juan Emmanuel Dewez, Iza Ciglenecki, Diana M Gibb, Matthew E Coldiron, Roberta Petrucci, Elizabeth C George","doi":"10.1056/NEJMoa2505752","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>International recommendations advise against the use of intravenous rehydration therapy in children with severe acute malnutrition because of the concern about fluid overload, but evidence to support this concern is lacking. Given the high mortality associated with the current recommendations, the adoption of intravenous rehydration strategies might improve outcomes.</p><p><strong>Methods: </strong>We conducted a factorial, open-label superiority trial in four countries in Africa. Children 6 months to 12 years of age with severe acute malnutrition with gastroenteritis and dehydration underwent randomization in a 2:1:1 ratio to one of three rehydration strategies: oral rehydration, plus intravenous boluses for shock; a rapid intravenous strategy that consisted of lactated Ringer's solution (100 ml per kilogram of body weight) administered over a period of 3 to 6 hours, with boluses for shock; or a slow intravenous strategy that consisted of the same solution administered over a period of 8 hours, with no boluses. The primary end point was death at 96 hours.</p><p><strong>Results: </strong>A total of 272 children underwent randomization; 138 were assigned to the oral strategy, 67 to the rapid intravenous strategy, and 67 to the slow intravenous strategy. Participants were followed for 28 days. A nasogastric tube was used for oral rehydration in 126 of 135 participants (93%) in the oral group and in 82 of 126 (65%) in the intravenous groups. Intravenous boluses were administered at admission in 12 participants (9%) in the oral group, 7 (10%) in the rapid intravenous group, and none in the slow intravenous group. At 96 hours, 11 participants (8%) in the oral group and 9 (7%) in the intravenous groups (5 in the rapid group and 4 in the slow group) had died (risk ratio, 1.02; 95% confidence interval [CI], 0.41 to 2.52; P = 0.69). At 28 days, 17 participants (12%) in the oral group and 14 (10%) in the intravenous groups had died (hazard ratio, 0.85; 95% CI, 0.41 to 1.78). Serious adverse events occurred in 32 participants (23%) in the oral group, 14 (21%) in the rapid intravenous group, and 10 (15%) in the slow intravenous group. No evidence of pulmonary edema, heart failure, or fluid overload was noted.</p><p><strong>Conclusions: </strong>Among children with severe acute malnutrition and gastroenteritis, no evidence of a difference in mortality at 96 hours was noted between oral and intravenous rehydration strategies. (Funded by the Joint Global Health Trials scheme and others; GASTROSAM Current Controlled Trials number, ISRCTN76149273.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":96.2000,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7617792/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"New England Journal of Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1056/NEJMoa2505752","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0

Abstract

Background: International recommendations advise against the use of intravenous rehydration therapy in children with severe acute malnutrition because of the concern about fluid overload, but evidence to support this concern is lacking. Given the high mortality associated with the current recommendations, the adoption of intravenous rehydration strategies might improve outcomes.

Methods: We conducted a factorial, open-label superiority trial in four countries in Africa. Children 6 months to 12 years of age with severe acute malnutrition with gastroenteritis and dehydration underwent randomization in a 2:1:1 ratio to one of three rehydration strategies: oral rehydration, plus intravenous boluses for shock; a rapid intravenous strategy that consisted of lactated Ringer's solution (100 ml per kilogram of body weight) administered over a period of 3 to 6 hours, with boluses for shock; or a slow intravenous strategy that consisted of the same solution administered over a period of 8 hours, with no boluses. The primary end point was death at 96 hours.

Results: A total of 272 children underwent randomization; 138 were assigned to the oral strategy, 67 to the rapid intravenous strategy, and 67 to the slow intravenous strategy. Participants were followed for 28 days. A nasogastric tube was used for oral rehydration in 126 of 135 participants (93%) in the oral group and in 82 of 126 (65%) in the intravenous groups. Intravenous boluses were administered at admission in 12 participants (9%) in the oral group, 7 (10%) in the rapid intravenous group, and none in the slow intravenous group. At 96 hours, 11 participants (8%) in the oral group and 9 (7%) in the intravenous groups (5 in the rapid group and 4 in the slow group) had died (risk ratio, 1.02; 95% confidence interval [CI], 0.41 to 2.52; P = 0.69). At 28 days, 17 participants (12%) in the oral group and 14 (10%) in the intravenous groups had died (hazard ratio, 0.85; 95% CI, 0.41 to 1.78). Serious adverse events occurred in 32 participants (23%) in the oral group, 14 (21%) in the rapid intravenous group, and 10 (15%) in the slow intravenous group. No evidence of pulmonary edema, heart failure, or fluid overload was noted.

Conclusions: Among children with severe acute malnutrition and gastroenteritis, no evidence of a difference in mortality at 96 hours was noted between oral and intravenous rehydration strategies. (Funded by the Joint Global Health Trials scheme and others; GASTROSAM Current Controlled Trials number, ISRCTN76149273.).

静脉补液治疗严重急性营养不良伴肠胃炎。
背景:由于担心体液超载,国际建议不建议对严重急性营养不良儿童使用静脉补液疗法,但缺乏支持这一担忧的证据。鉴于目前建议的高死亡率,采用静脉补液策略可能会改善结果。方法:我们在非洲的四个国家进行了一项因子、开放标签的优势试验。6个月至12岁的严重急性营养不良伴肠胃炎和脱水的儿童按2:1:1的比例随机分配到三种补液策略中的一种:口服补液加静脉注射治疗休克;快速静脉注射策略,包括乳酸林格氏液(每公斤体重100毫升),给药时间为3至6小时,并伴有休克丸;或者是缓慢的静脉注射策略,由相同的溶液在8小时内给药,没有丸剂。主要终点为96小时死亡。结果:共有272名儿童接受了随机分组;138人接受口服治疗,67人接受快速静脉注射,67人接受慢速静脉注射。参与者被跟踪了28天。135名口服组患者中有126名(93%)使用鼻胃管进行口服补液,126名静脉注射组中有82名(65%)使用鼻胃管进行口服补液。入院时口服组12例(9%),快速静脉注射组7例(10%),慢速静脉注射组0例。96小时时,口服组11例(8%)死亡,静脉注射组9例(7%)死亡(快速组5例,慢速组4例)(风险比1.02;95%置信区间[CI], 0.41 ~ 2.52;p = 0.69)。28天,口服组17例(12%)和静脉注射组14例(10%)死亡(风险比0.85;95% CI, 0.41 ~ 1.78)。严重不良事件发生在口服组32例(23%),快速静脉组14例(21%),慢速静脉组10例(15%)。没有发现肺水肿、心力衰竭或体液过量的证据。结论:在患有严重急性营养不良和肠胃炎的儿童中,没有证据表明口服和静脉补液策略在96小时内的死亡率有差异。(由全球联合卫生试验计划和其他计划资助;GASTROSAM电流对照试验号,ISRCTN76149273)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
New England Journal of Medicine
New England Journal of Medicine 医学-医学:内科
CiteScore
145.40
自引率
0.60%
发文量
1839
审稿时长
1 months
期刊介绍: The New England Journal of Medicine (NEJM) stands as the foremost medical journal and website worldwide. With an impressive history spanning over two centuries, NEJM boasts a consistent publication of superb, peer-reviewed research and engaging clinical content. Our primary objective revolves around delivering high-caliber information and findings at the juncture of biomedical science and clinical practice. We strive to present this knowledge in formats that are not only comprehensible but also hold practical value, effectively influencing healthcare practices and ultimately enhancing patient outcomes.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信