Femme et Homme
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Extrait
Background and study aims Shock is a medical emergency which occurs when there is not enough blood flow around the body. As a result of tissues not receiving enough oxygen, too much acid builds up in the body (metabolic acidosis). Children with severe malaria often have metabolic acidosis as a complication of shock. The usual treatment for shock is to replenish lost fluid (fluid resuscitation). We have shown previously that human albumin solution (HAS: a by-product of blood transfusion) safely corrects this acidosis and improves the outcome of children with severe malaria complicated by acidosis. HAS is currently expensive and not widely available in Africa. This study aims to examine the safety and dose required for the correction of acidosis of lower cost infusions called colloids: Gelofusine, Dextran 70 and Hetastarch. These will be compared to a control group of children receiving HAS. The results of this study will form the basis for the future larger trials comparing colloidal solutions with saline or maintenance alone, which are required before specific treatment recommendations can be made. Who can participate? Children aged over 3 months, either sex, who have severe falciparum malaria (impaired consciousness and or deep breathing) and metabolic acidosis. What does the study involve? Children will be randomly allocated to undergo fluid resuscitation with either HAS, Gelofusine, Dextran 70 or Hetastarch. What are the possible benefits and risks of participating? Children will be closely monitored and fluid will be administered cautiously. Where is the study run from? The study will be based at the KEMRI Centre for Geographic Medicine Research (Coast) at Kilifi District Hospital (KDH), Kenya. When is the study starting and how long is it expected to run for? The study started in December 2004 and ended in December 2008. Who is funding the study? The Wellcome Trust (UK). Who is the main contact? Professor Kathryn Maitland [email protected]
Critère d'inclusion
- Severe falciparum malaria