دورية أكاديمية
Efficacy of dopamine, epinephrine and blood transfusion for treatment of fluid refractory shock in children with severe acute malnutrition or severe underweight and cholera or other dehydrating diarrhoeas: protocol for a randomised controlled clinical trial.
| العنوان: | Efficacy of dopamine, epinephrine and blood transfusion for treatment of fluid refractory shock in children with severe acute malnutrition or severe underweight and cholera or other dehydrating diarrhoeas: protocol for a randomised controlled clinical trial. |
|---|---|
| المؤلفون: | Sarmin M; Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research,Bangladesh (icddr,b), Dhaka, Bangladesh., Shaly NJ; Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research,Bangladesh (icddr,b), Dhaka, Bangladesh., Sultana T; Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research,Bangladesh (icddr,b), Dhaka, Bangladesh., Tariqujjaman M; Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research,Bangladesh (icddr,b), Dhaka, Bangladesh., Shikha SS; Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research,Bangladesh (icddr,b), Dhaka, Bangladesh., Mariam N; Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research,Bangladesh (icddr,b), Dhaka, Bangladesh., Jeorge DH; Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research,Bangladesh (icddr,b), Dhaka, Bangladesh., Tabassum M; Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research,Bangladesh (icddr,b), Dhaka, Bangladesh., Nahar B; Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research,Bangladesh (icddr,b), Dhaka, Bangladesh., Afroze F; Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research,Bangladesh (icddr,b), Dhaka, Bangladesh., Shahrin L; Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research,Bangladesh (icddr,b), Dhaka, Bangladesh., Hossain MI; Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research,Bangladesh (icddr,b), Dhaka, Bangladesh., Alam B; Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research,Bangladesh (icddr,b), Dhaka, Bangladesh., Faruque ASG; Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research,Bangladesh (icddr,b), Dhaka, Bangladesh., Islam MM; Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research,Bangladesh (icddr,b), Dhaka, Bangladesh., Osmany DMF; Department of Cardiology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh., Ahmed CM; Department of Cardiology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh., Manji K; Department of Pediatrics, Muhimbili University of Health and Allied Sciences, Dar-es-Salaam, Tanzania., Kissoon N; Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada., Chisti MJ; Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research,Bangladesh (icddr,b), Dhaka, Bangladesh chisti@icddrb.org., Ahmed T; Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research,Bangladesh (icddr,b), Dhaka, Bangladesh. |
| المصدر: | BMJ open [BMJ Open] 2023 Apr 12; Vol. 13 (4), pp. e068660. Date of Electronic Publication: 2023 Apr 12. |
| نوع المنشور: | Clinical Trial Protocol; Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: [London] : BMJ Publishing Group Ltd, 2011- |
| مواضيع طبية MeSH: | Cholera* , Severe Acute Malnutrition*/complications , Severe Acute Malnutrition*/therapy, Humans ; Child ; Infant ; Child, Preschool ; Dopamine/therapeutic use ; Thinness ; Treatment Outcome ; Bangladesh ; Epinephrine/therapeutic use ; Diarrhea/complications ; Diarrhea/therapy ; Blood Transfusion ; Randomized Controlled Trials as Topic |
| مستخلص: | Introduction: Diarrhoea is one of the leading causes of under-5 childhood mortality and accounts for 8% of 5.4 million global under-5 deaths. In severely malnourished children, diarrhoea progresses to shock, where the risk of mortality is even higher. At icddr,b Dhaka Hospital, the fatality rate is as high as 69% in children with severe malnutrition and fluid refractory septic shock. To date, no study has evaluated systematically the effects of inotrope or vasopressor or blood transfusion in children with dehydrating diarrhoea (eg, in cholera) and severe acute malnutrition (SAM) or severe underweight who are in shock and unresponsive to WHO-recommended fluid therapy. To reduce the mortality of severely malnourished children presenting with diarrhoea and fluid refractory shock, we aim to compare the efficacy of blood transfusion, dopamine and epinephrine in fluid refractory shock in children who do not respond to WHO-recommended fluid resuscitation. Methods and Analysis: In this randomised, three-arm, controlled, non-masked clinical trial in children 1-59 months old with SAM or severe underweight and fluid refractory shock, we will compare the efficacy of dopamine or epinephrine administration versus blood transfusion in children who failed to respond to WHO-recommended fluid resuscitation. The primary outcome variable is the case fatality rate. The effect of the intervention will be assessed by performing an intention-to-treat analysis. Recruitment and data collection began in July 2021 and are now ongoing. Results are expected by May 2023. Ethics and Dissemination: This study has been approved by the icddr,b Institutional Review Board. We adhere to the 'Declaration of Helsinki' (2000), guidelines for Good Clinical Practice. Before enrolment, we collect signed informed consent from the parents or caregivers of the children. We will publish the results in a peer-reviewed journal and will arrange a dissemination seminar. Trial Registration Number: NCT04750070. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.) |
| References: | Acta Paediatr. 2011 Dec;100(12):e275-9. (PMID: 21627690) Pediatr Crit Care Med. 2016 Nov;17(11):e502-e512. (PMID: 27673385) Ann Pediatr Cardiol. 2010 Jul;3(2):113-8. (PMID: 21234188) Eur J Clin Nutr. 2006 Apr;60(4):502-10. (PMID: 16319835) Arch Dis Child. 1993 Sep;69(3 Spec No):284-7. (PMID: 8215566) Crit Care Med. 2015 Nov;43(11):2292-302. (PMID: 26323041) Ann Intern Med. 2013 Feb 5;158(3):200-7. (PMID: 23295957) Acta Paediatr. 2014 Jul;103(7):e306-11. (PMID: 24661049) J Am Coll Nutr. 2005 Feb;24(1):38-43. (PMID: 15670983) Emerg Med J. 2009 Feb;26(2):87-91. (PMID: 19164614) N Engl J Med. 2011 Jun 30;364(26):2483-95. (PMID: 21615299) J Med Ultrasound. 2017 Oct-Dec;25(4):191-194. (PMID: 30065491) Crit Care Med. 2004 Aug;32(8):1703-8. (PMID: 15286547) PLoS One. 2015 Oct 06;10(10):e0139966. (PMID: 26440279) BMC Med. 2013 Mar 14;11:68. (PMID: 23496872) Intensive Care Med. 2020 Feb;46(Suppl 1):10-67. (PMID: 32030529) Lancet. 1999 Jun 5;353(9168):1919-22. (PMID: 10371570) Crit Care Med. 2009 Feb;37(2):666-88. (PMID: 19325359) |
| معلومات مُعتمدة: | United Kingdom WT_ Wellcome Trust |
| فهرسة مساهمة: | Keywords: Paediatric gastroenterology; Paediatric intensive & critical care; Respiratory infections |
| سلسلة جزيئية: | ClinicalTrials.gov NCT04750070 |
| المشرفين على المادة: | VTD58H1Z2X (Dopamine) YKH834O4BH (Epinephrine) |
| تواريخ الأحداث: | Date Created: 20230412 Date Completed: 20230414 Latest Revision: 20230423 |
| رمز التحديث: | 20230423 |
| مُعرف محوري في PubMed: | PMC10106066 |
| DOI: | 10.1136/bmjopen-2022-068660 |
| PMID: | 37045565 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2044-6055 |
|---|---|
| DOI: | 10.1136/bmjopen-2022-068660 |