Abstract
BackgroundWorld Health Organization rehydration management guidelines (plan C) for severe dehydration are widely practiced in resource-poor settings, but never formally evaluated in a trial. The Fluid Expansion as a Supportive Therapy trial raised concerns regarding the safety of bolus therapy for septic shock, warranting a formal evaluation of rehydration therapy for gastroenteritis.MethodsA multi-centre open-label phase II randomised controlled trial evaluated two rehydration strategies in 122 Ugandan/Kenyan children aged 60 days to 12 years with severe dehydration secondary to gastroenteritis. We compared the safety and efficacy of standard rapid rehydration using Ringer’s lactate (100 ml/kg over 3 h (6 h if < 1 year), incorporating 0.9% saline boluses for children with shock (plan C) versus slower rehydration: 100 ml/kg Ringer’s lactate over 8 h (all ages) without boluses (slow: experimental). The primary outcome was the frequency of serious adverse events (SAE) within 48 h including cardiovascular, respiratory and neurological complications. Secondary outcomes included clinical, biochemical and physiological measures of response to treatment by intravenous rehydration.ResultsOne hundred twenty-two eligible children (median (IQR) age 8 (6–12) months) were randomised to plan C (n = 61) or slow (n = 61), with two (2%) lost to follow-up at day 7). Following randomisation mean (SD) time to start intravenous rehydration started was 15 min (18) in both arms. Mean (SD) fluid received by 1 hour was greater in plan C (mean 20.2 ml/kg (12.2) and 33.1 ml/kg (17) for children < 1 year and >− 1 year respectively) versus 10.4 ml/kg (6.6) in slow arm. By 8 hours volume received were similar mean (SD) plan C: 96.3 ml/kg (15.6) and 97.8 ml/kg (10.0) for children < 1 and ≥ 1 year respectively vs 93.2 ml/kg (12.2) in slow arm. By 48-h, three (5%) plan C vs two (3%) slow had an SAE (risk ratio 0.67, 95% CI 0.12–3.85, p = 0.65). There was no difference in time to the correction of dehydration (p = 0.9) or time to discharge (p = 0.8) between groups. Atrial natriuretic peptide levels rose substantially by 8 hours in both arms, which persisted to day 7. Day 7 weights suggested only 33 (29%) could be retrospectively classified as severely dehydration (≥ 10% weight loss).ConclusionSlower rehydration over 8 hours appears to be safe, easier to implement than plan C. Future large trials with mortality as the primary endpoint are warranted.Trial registrationISRCTN67518332. Date applied 31 August 2016.
Highlights
World Health Organization rehydration management guidelines for severe dehydration are widely practiced in resource-poor settings, but never formally evaluated in a trial
A large case-control study, Global Enteric Multicentre study of gastroenteritis (GEMS), conducted in Africa and Asia showed that children with moderate/severe gastroenteritis seeking care at health centres are 8.5 times more likely to die than nongastroenteritis controls [3, 4]
Study design and treatment protocol We conducted a multi-centre, open-label phase II randomised controlled trial comparing World Health Organization (WHO) standard versus slow intravenous rehydration of children admitted to hospital with gastroenteritis and severe dehydration
Summary
World Health Organization rehydration management guidelines (plan C) for severe dehydration are widely practiced in resource-poor settings, but never formally evaluated in a trial. Intravenous fluids are recommended for resuscitation of children with severe dehydration, defined as the presence of two or more of the following clinical features: sunken eyes, skin pinch goes back very slowly ≥ 2 seconds (s), lethargy and/or inability to drink (under the protocol called ‘plan C’), using 100 ml/kg of Ringer’s lactate or 0.9% saline [6] This is the approximate volume estimated to have been lost in children with 10% dehydration and is recommended to be given over 3 h (or 6 h in children < 1 year). For children presenting with shock (defined as the presence of all three of weak and fast pulse, temperature gradient and capillary refilling time > 3 s), WHO recommends initial fluid boluses given for shock (i.e. up to 3 boluses of 20 ml/kg of normal (0.9%) saline given as rapidly as possible) followed directly by Step 2, i.e. 90–130 ml/kg These management guidelines are recommended in resourcepoor settings, despite no formal testing in a clinical trial [7]. A review of the evidence underpinning WHO management guidelines in 2012, with regard to shock and rehydration management, focused principally on the type of fluid for resuscitation but did not consider the rate or volume [5]
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