phase ii trial of isotonic fluid resuscitation in kenyan children with severe malnutrition and hypovolaemia二期试验等渗液体复苏在肯尼亚儿童严重营养不良和hypovolaemia.pdfVIP

Akech et al. BMC Pediatrics 2010, 10:71 /1471-2431/10/71 RESEARCH ARTICLE Open Access Phase II trial of isotonic fluid resuscitation in Kenyan children with severe malnutrition and hypovolaemia 1 1 1 1 1,2,3* Samuel O Akech , Japhet Karisa , Phellister Nakamya , Mwanamvua Boga , Kathryn Maitland Abstract Background: Children with severe malnutrition who develop shock have a high mortality. Contrary to contemporaneous paediatric practice, current guidelines recommend use of low dose hypotonic fluid resuscitation (half-strength Darrows/5% dextrose (HSD/5D). We evaluated the safety and efficacy of this guideline compared to resuscitation with a standard isotonic solution. Methods: A Phase II randomised controlled, safety and efficacy trial in Kenyan children aged over 6 months with severe malnutrition and shock including children with severe dehydration/shock and presumptive septic shock (non-diarrhoeal shock). Eligible children were randomised to HSD/5D or Ringer’s Lactate (RL). A maximum of two boluses of 15 ml/kg of HSD/5D were given over two hours (as recommended by guidelines) while those randomised to RL received 10 ml/kg aliquots half hourly (maximum 40 ml/kg). Primary endpoint was resolution of shock at 8 and 24 hours. Secondary outcomes included resolution of acidosis, adverse events and mortality. Results: 61 children were enrolled: 41 had shock and severe dehydrating diarrhoea, 20 had presumptive septic shock; 69% had decompensated shock. By 8 hours response to volume resuscitation was poor with shock persisting in most children:-HSD/5D 15/22 (68%) and RL14/25 (52%), p = 0.39. Oliguria was more prevalent at 8 hours in the HSD/5D group, 9/22 (41%), compared to RL-3/25 (12%), p = 0.02. Mortality was high