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G/TUES/INT1 VOLUME EXPANSION WITH ALBUMIN COMPARED TO GELOFUSINE IN CHILDREN WITH SEVERE MALARIA: RESULTS OF A CONTROLLED TRIAL
S. Akech1, S. Gwer1, R. Idro1, G. Fegan2, A. Eziefula1, C. Newton3, M. Levin4, K. Maitland4.1Centre for Geographic Medicine Research (coast), Kenya Medical Research Institute (KEMRI), Kilifi, Kenya; 2Infectious Diseases Epidemiology Unit, London School of Hygiene and Tropical Medicine, London, UK; 3Neurosciences Unit, Institute of Child Health, The Wolfson Centre, Mecklenburgh Square, London, UK; 4Department of Paediatrics and Wellcome Trust Centre for Clinical Tropical Medicine, Faculty of Medicine, Imperial College, Norfolk Place, London, UK
Aims: Previous studies have shown that resuscitation with albumin infusion resulted in a lower mortality than saline in severe malaria. Whether the apparent benefit of albumin is due solely to its colloidal properties, and thus might also be achieved with other synthetic colloids, or due to the many other unique physiological properties of albumin is unknown. As albumin is costly and not readily available in Africa examination of more affordable colloids are warranted. In order to inform the design of definitive Phase III trials we compared volume expansion with the synthetic colloid Gelofusine with albumin.
Methods: Phase II study at Kilifi District Hospital, Kenya involving children admitted with severe falciparum malaria (impaired consciousness or deep breathing), metabolic acidosis (base deficit >8) and clinical features of shock. Volume resuscitation was done with either 4.5% human albumin solution or Gelofusine. Primary endpoint was resolution of shock and acidosis; secondary endpoints were in-hospital mortality and adverse events including neurological sequelae.
Results: Eighty eight children enrolled: 44 received Gelofusine and 44 received albumin. No significant difference seen in the resolution of shock or acidosis between the groups. Mortality was lower in patients receiving albumin (1/44; 2.3%) than in those treated with Gelofusine (7/44; 16%) by intention to treat (Fisher’s …