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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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3 March 2020 |
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Main ID: |
ISRCTN58063971 |
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Date of registration:
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22/07/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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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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The role of hypovolaemia In the acidosis of severe malaria in children |
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Date of first enrolment:
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01/05/2001 |
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Target sample size:
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53 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN58063971 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Phase II
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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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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Kilifi
Kenya |
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Telephone:
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+254 (0)73 3411022 |
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Email:
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kmaitland@kilifi.mimcom.net |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Severe malaria
Infections and Infestations
Malaria
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Intervention(s)
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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(s)
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Percentage reduction in acidosis by eight hours.
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Secondary Outcome(s)
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1. Death
2. Severe adverse events
3. Neurological sequalae
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Source(s) of Monetary Support
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The Wellcome Trust (UK) (grant ref: 062258)
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Ethics review
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Status:
Approval date:
Contact:
Not provided at time of registration
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/10/2002 |
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URL:
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