May 6, 2011 (Denver, Colorado) — A blinded and randomized trial comparing a rapid intravenous rehydration (RIVR) protocol with the standard approach in a statistically significant population of pediatric patients with gastroenteritis has failed to find any benefit with the rapid approach. The increased risks that accompany RIVR do not warrant its recommended use, researchers report.
The findings were presented by Stephen Freedman, MDCM, from The Hospital for Sick Children, Toronto, Ontario, Canada, here at the Pediatric Academic Societies and Asian Society for Pediatric Research 2011 Annual Meeting.
"Oral rehydration therapy for children is appropriate but is underused. In particular, rapid intravenous rehydration lacks a standard definition and evidence of efficacy. Given the potential risks associated with this approach, our data indicate that its use should be reconsidered," Dr. Freedman told Medscape Medical News.
The study, which involved 226 children 3 months to 11 years of age who were recruited from December 2006 through April 2010, compared standard intravenous (IV) rehydration (0.9% saline, 20 mL/kg, over 1 h; n = 112) with RIVR (0.9% saline, 60 mL/kg, over 1 h; n = 114). Both groups subsequently received IV fluids for another 3 hours and standard oral rehydration therapy. Patients, nurses, and attending physicians were blinded to the treatment group (the IV pump was sound-proofed to mask any differences).
The primary outcome was clinical evidence of rehydration within 2 hours of starting the IV. Secondary outcomes included the need for longer-term therapy (hospital admission at the time of presentation or within 72 hours, or emergency department stay exceeding 6 hours once treatment was started), clinical rehydration scores (determined every 30 minutes for 4 hours), time to discharge, and return visit(s) to the hospital. A battery of statistical analyses conducted throughout the study clarified the clinical significance of both approaches over time.
The various baseline characteristics were similar between the 2 groups. Clinical rehydration was not significantly different between the RIVR group and the standard group (36.0% vs 29.5%; 95% confidence interval [CI] of the absolute difference, –5.7 to 18.7; P = .32). Even after adjustment for weight, dehydration score at baseline, and pH at baseline, RIVR did not influence the primary outcome (odds ratio [OR], 1.8; 95% CI, 0.90 to 3.5; P = .10). The proportion of patients requiring prolonged therapy was similar in the RIVR and standard groups (51.8% vs 42.9%; 95% CI of the absolute difference, 21.0 to –5.0; P = .19).
Although the clinical dehydration scores were consistently similar between the RIVR and standard groups (P = .69), as were revisits (14% vs 12%), those treated with RIVR remained in the hospital longer (median time to discharge, 6.3 vs 5.0 h; P = .03).
"For those patients in our hospital who required intravenous rehydration, the use of rapid and large-volume rehydration did not improve the clinical outcome," Dr. Freedman told Medscape Medical News.
The rapid rehydration might have failed because of the possibility of hyperchloremic metabolic acidosis resulting from the administration of a larger volume of fluid, lag time in initiating treatment, and altered dehydration scores by undefined factors.
For the time being, the risks for rapid rehydration outweigh the benefits, Dr. Freedman asserted.
"This is a very good study that reflects the need to establish how fast we rehydrate. Could we rehydrate with the standard volume in a shorter time, for example? These data show the need to reassess current practice," Christine Seroogy, MD, associate professor of pediatrics at the University of Wisconsin–Madison, told Medscape Medical News.
The authors and Dr. Seroogy have disclosed no relevant financial relationships.
Pediatric Academic Societies (PAS) and Asian Society for Pediatric Research 2011 Annual Meeting: Abstract 4135.2. Presented May 3, 2011.
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