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      Rapid versus standard intravenous rehydration in paediatric gastroenteritis: pragmatic blinded randomised clinical trial

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          Abstract

          Objective To determine if rapid rather than standard intravenous rehydration results in improved hydration and clinical outcomes when administered to children with gastroenteritis.

          Design Single centre, two arm, parallel randomised pragmatic controlled trial. Blocked randomisation stratified by site. Participants, caregivers, outcome assessors, investigators, and statisticians were blinded to the treatment assignment.

          Setting Paediatric emergency department in a tertiary care centre in Toronto, Canada.

          Participants 226 children aged 3 months to 11 years; complete follow-up was obtained on 223 (99%). Eligible children were aged over 90 days, had a diagnosis of dehydration secondary to gastroenteritis, had not responded to oral rehydration, and had been prescribed intravenous rehydration. Children were excluded if they weighed less than 5 kg or more than 33 kg, required fluid restriction, had a suspected surgical condition, or had an insurmountable language barrier. Children were also excluded if they had a history of a chronic systemic disease, abdominal surgery, bilious or bloody vomit, hypotension, or hypoglycaemia or hyperglycaemia.

          Interventions Rapid (60 mL/kg) or standard (20 mL/kg) rehydration with 0.9% saline over an hour; subsequent fluids administered according to protocol.

          Main outcome measures Primary outcome: clinical rehydration, assessed with a validated scale, two hours after the start of treatment. Secondary outcomes: prolonged treatment, mean clinical dehydration scores over the four hour study period, time to discharge, repeat visits to emergency department, adequate oral intake, and physician’s comfort with discharge. Data from all randomised patients were included in an intention to treat analysis.

          Results 114 patients were randomised to rapid rehydration and 112 to standard. One child was withdrawn because of severe hyponatraemia at baseline. There was no evidence of a difference between the rapid and standard rehydration groups in the proportions of participants who were rehydrated at two hours (41/114 (36%) v 33/112 (30%); difference 6.5% (95% confidence interval −5.7% to 18.7%; P=0.32). The results did not change after adjustment for weight, baseline dehydration score, and baseline pH (odds ratio 1.8, 0.90 to 3.5; P=0.10). The rates of prolonged treatment were similar (52% rapid v 43% standard; difference 8.9%, 21% to −5%; P=0.19). Although dehydration scores were similar throughout the study period (P=0.96), the median time to discharge was longer in the rapid group (6.3 v 5.0 hours; P=0.03).

          Conclusions There are no relevant clinical benefits from the administration of rapid rather than standard intravenous rehydration to haemodynamically stable children deemed to require intravenous rehydration.

          Trail registration Clinical Trials NCT00392145.

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          Most cited references 29

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          PEDIATRICS

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            Is this child dehydrated?

            The ability to assess the degree of dehydration quickly and accurately in infants and young children often determines patient treatment and disposition. To systematically review the precision and accuracy of symptoms, signs, and basic laboratory tests for evaluating dehydration in infants and children. We identified 1561 potential articles by multiple search strategies of the MEDLINE database through PubMed. Searches of bibliographies of retrieved articles, the Cochrane Library, textbooks, and private collections of experts in the field yielded an additional 42 articles. Twenty-six of 1603 reviewed studies contained original data on the precision or accuracy of findings for the diagnosis of dehydration in young children (1 month to 5 years). Two of the 3 authors independently reviewed and abstracted data for estimating the likelihood ratios (LRs) of diagnostic tests. We eliminated 13 of the 26 studies because of the lack of an accepted diagnostic standard or other limitation in study design. The other 13 studies were included in the review. The most useful individual signs for predicting 5% dehydration in children are an abnormal capillary refill time (LR, 4.1; 95% confidence interval [CI], 1.7-9.8), abnormal skin turgor (LR, 2.5; 95% CI, 1.5-4.2), and abnormal respiratory pattern (LR, 2.0; 95% CI, 1.5-2.7). Combinations of examination signs perform markedly better than any individual sign in predicting dehydration. Historical points and laboratory tests have only modest utility for assessing dehydration. The initial assessment of dehydration in young children should focus on estimating capillary refill time, skin turgor, and respiratory pattern and using combinations of other signs. The relative imprecision and inaccuracy of available tests limit the ability of clinicians to estimate the exact degree of dehydration.
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              The effect of intravenous lactated Ringer's solution versus 0.9% sodium chloride solution on serum osmolality in human volunteers.

              Animal studies have shown that large volumes of IV lactated Ringer's solution (LR) decrease serum osmolality, thereby increasing cerebral water. These studies have led to recommendations to limit LR to avoid cerebral edema in neurosurgical patients. Eighteen healthy human volunteers aged 20-48 yr received 50 mL/kg LR over 1 h on one occasion and 0.9% sodium chloride (NS) on another. Venous samples were taken at baseline (T1), at infusion end (T2), and 1 h after T2 (T3). Time until first urination was noted. With LR, serum osmolality decreased by 4+/-3 mOsm/kg from T1 to T2 and increased insignificantly with NS. At T3, osmolality returned almost to baseline in the LR group. Blood pH increased from T1 to T2 with LR by 0.04+/-0.04 and decreased with NS by 0.04+/-0.04. These pH changes persisted at T3. Subjective mental changes occurred only with NS. Abdominal discomfort was more common with NS. Time until first urination was longer with NS (106+/-11 min) than with LR (75+/-10 min) (P < 0.001). In healthy humans, an infusion of large volumes of LR, but not NS, transiently decreased serum osmolality, whereas acidosis associated with NS persisted and urinary output was slower with NS. Large volumes of lactated Ringer's solution administered to healthy humans produced small transient changes in serum osmolality. Large volumes of sodium chloride did not change osmolality but resulted in lower pH.
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                Author and article information

                Contributors
                Role: associate professor of paediatrics
                Role: professor of paediatrics
                Role: senior scientist
                Role: professor of paediatrics
                Journal
                BMJ
                bmj
                BMJ : British Medical Journal
                BMJ Publishing Group Ltd.
                0959-8138
                1468-5833
                2011
                2011
                17 November 2011
                : 343
                Affiliations
                [1 ]Division of Paediatric Emergency Medicine, Hospital for Sick Children, Toronto, ON, Canada
                [2 ]Division of Paediatric Gastroenterology, Hepatology, and Nutrition, Hospital for Sick Children, Toronto
                [3 ]Child Health Evaluative Sciences, Hospital for Sick Children Research Institute, Hospital for Sick Children, Toronto
                [4 ]Department of Paediatrics, Faculty of Medicine, University of Toronto, Toronto
                [5 ]Health Policy, Management and Evaluation, Faculty of Medicine, University of Toronto, Toronto
                [6 ]Division of Paediatric Medicine and the Paediatric Outcomes Research Team, Hospital for Sick Children, Toronto
                [7 ]Dalla Lana School of Public Health, University of Toronto, Toronto
                Author notes
                Correspondence to: S B Freedman, Division of Paediatric Emergency Medicine, The Hospital for Sick Children, 555 University Avenue, Toronto, ON, Canada, M5G 1X8 stephen.freedman@ 123456sickkids.ca
                Article
                fres890608
                10.1136/bmj.d6976
                3219422
                22094316
                © Freedman et al 2011

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

                Product
                Categories
                Research
                Infection (Gastroenterology)
                Clinical Trials (Epidemiology)
                Diabetes
                Metabolic Disorders

                Medicine

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