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ISRCTN
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ISRCTN35536139
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ClinicalTrials.gov identifier
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Public title
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Role of hypovolaemia in the acidosis of severe malaria
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Scientific title
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Role of hypovolaemia in the acidosis of severe malaria: a randomised controlled trial
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Acronym
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N/A
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Serial number at source
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062258
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Study hypothesis
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This study adds to and extends the original aims of previous studies. In those we provided new, clear evidence for the presence of hypovolaemia in severe malaria and showed that this could be safely corrected by volume resuscitation with either 0.9% saline or 4.5% human albumin solution (HAS). In a formal randomised controlled trial we showed that volume expansion with albumin was associated with a significantly lower mortality in children with severe malaria acidosis, especially those admitted in coma. As HAS is costly and not available in Africa in this current study we aim to examine the safety and dose required (efficacy) for the correction of hypovolaemia of lower cost colloids: Gelofusine, Dextran 70 and Hetastarch. These will be compared to a ‘control’ group of children receiving HAS. In this prospective study we aim to enrol children and randomised them to either Gelofusin, Dextran 70, Hetastarch or HAS. The results of this study will form the basis for the future design of multicentre trials comparing colloidal solutions with saline or maintenance alone, which are required before specific treatment recommendations can be made.
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Lay summary
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Ethics approval
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Kenya Medical Research Institute (KEMRI) National Scientific Steering Committee and Ethics Review Board approved the study July/August 2004 (ref: 864)
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Study design
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Randomised controlled trial
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Countries of recruitment
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Kenya
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Disease/condition/study domain
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Severe falciparum malaria
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Participants - inclusion criteria
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1. Kenyan children aged more than three months, either sex
2. Clinical features of severe falciparum malaria (impaired consciousness and or deep breathing)
3. Metabolic acidosis (base deficit more than or equal to eight)
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Participants - exclusion criteria
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1. Children of families who decline consent
2. Children with:
2.1. Severe anaemia (haemoglobin less than 5 g/dl)
2.2. Cerebrospinal fluid (CSF) changes consistent with meningitis
2.3. Clinical features of pulmonary oedema (defined as clinical evidence presence of fine crepitations in both lungs plus oxygen saturations less than 95%)
2.4. Evidence of raised intracranial pressure (brain stem features of coning, systolic blood pressure more than 90% centile for age plus falling heart rate and/or papilloedema)
2.5. Any conditions that may contraindicate the use of volume replacement, e.g. established renal failure or known congenital heart disease
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Anticipated start date
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01/11/2004
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Anticipated end date
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31/10/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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40 in each group (160 in total)
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Interventions
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Fluid resuscitation with either:
1. Human albumin solution
2. Gelofusine
3. Dextran 70
4. Hetastarch
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Primary outcome measure(s)
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The resolution of clinical features of shock and case fatality
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Secondary outcome measure(s)
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Development of major side effects or complications of volume resusciation:
1. Abnormal clotting indices
2. Pulmonary oedema
3. Raised intracranial pressure
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 062258)
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Trial website
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Publications
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1. 2003 retrospective review in http://www.ncbi.nlm.nih.gov/pubmed/12788961
2. 2005 preliminary results in http://www.ncbi.nlm.nih.gov/pubmed/15712076
3. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16998584
4. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20526196
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Contact name
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Dr
Kathryn
Maitland
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Address
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Wellcome Trust Research Unit
CGMR-coast KEMRI
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City/town
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Kilifi
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Zip/Postcode
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PO Box 230
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Country
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Kenya
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Tel
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+254 (0)415 22063
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Fax
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+254 (0)415 22390
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Email
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kmaitland@kilifi.mimcom.net
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Sponsor
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Imperial College London (UK)
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Address
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Prof Mike Levin
Department of Paediatrics and Wellcome Trust Centre for Clinical Tropical Medicine
Faculty of Medicine
Imperial College
Norfolk Place
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City/town
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London
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Zip/Postcode
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W2 1PG
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Country
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United Kingdom
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Tel
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+44 (0)20 7594 3990
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Email
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m.levin@imperial.ac.uk
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Sponsor website:
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http://www3.imperial.ac.uk/
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Date applied
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12/09/2005
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Last edited
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18/08/2010
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Date ISRCTN assigned
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14/10/2005
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