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ISRCTN
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ISRCTN58063971
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ClinicalTrials.gov identifier
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Public title
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The role of hypovolaemia In the acidosis of severe malaria in children
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Scientific title
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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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1. To establish to what degree hypovolaemia contributes to the clinical spectrum of severe malaria
2. To establish, through intervention studies, whether the acidosis of severe malaria can be corrected by adequate volume replacement
3. To examine the safety and efficacy of adequate volume replacement and determine the optimum intravenous fluid (0.9% saline or 4.5% albumin) to use in children with severe malaria
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Ethics approval
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Not provided at time of registration
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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 malaria
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Participants - inclusion criteria
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1. A clinical feature of severe malaria (prostration, coma or deep breathing) plus P. falciparum
2. A base deficit of more than eight
3. Parental consent
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Participants - exclusion criteria
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1. Clinical features of oedematous malnutrition
2. Features suggestive of pulmonary oedema (oxygen saturations <90% and bilateral creptitations)
3. Raised intracranial pressure (unequal pupillary reaction to light and/or raised blood pressure concurrent with bradycardia)
3. Refusal of consent
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Anticipated start date
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01/05/2001
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Anticipated end date
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01/10/2002
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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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To be added
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Interventions
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Open phase II randomised trial comparing the safety and efficacy of volume expansion with 0.9% saline or human albumin to control in children with severe malaria and moderate acidosis (base deficit of eight to 15) and comparing safety and efficacy of 0.9% saline and human albumin as volume expansion in children with severe malaria complicated by severe acidosis (base deficit of more than 15).
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Primary outcome measure(s)
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Percentage reduction in acidosis by eight hours.
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Secondary outcome measure(s)
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1. Death
2. Severe adverse events
3. Neurological sequalae
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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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Contact name
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Dr
Kathryn
Maitland
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Address
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KEMRI
KEMRI Centre for Geographic Medicine
P.O. Box 230
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City/town
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Kilifi
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Zip/Postcode
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-
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Country
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Kenya
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Tel
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+254 (0)73 3411022
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Fax
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+254 (0)522390
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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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Level 2, Faculty Building
Clinical Research Office
South Kensington campus
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City/town
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London
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Zip/Postcode
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SW7 2AZ
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Country
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United Kingdom
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Email
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clinical.researchoffice@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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22/07/2005
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Last edited
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13/12/2007
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Date ISRCTN assigned
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22/07/2005
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