Contact information
Type
Scientific
Primary contact
Dr Kathryn Maitland
ORCID ID
Contact details
KEMRI
KEMRI Centre for Geographic Medicine
P.O. Box 230
Kilifi
-
Kenya
+254 (0)73 3411022
kmaitland@kilifi.mimcom.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
062258
Study information
Scientific title
The role of hypovolaemia In the acidosis of severe malaria in children
Acronym
Study hypothesis
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
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Severe malaria
Intervention
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).
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measure
Percentage reduction in acidosis by eight hours.
Secondary outcome measures
1. Death
2. Severe adverse events
3. Neurological sequalae
Overall trial start date
01/05/2001
Overall trial end date
01/10/2002
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
53
Total final enrolment
53
Participant 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
Recruitment start date
01/05/2001
Recruitment end date
01/10/2002
Locations
Countries of recruitment
Kenya
Trial participating centre
KEMRI
Kilifi
-
Kenya
Sponsor information
Organisation
Imperial College London (UK)
Sponsor details
Level 2
Faculty Building
Clinical Research Office
South Kensington campus
London
SW7 2AZ
United Kingdom
-
clinical.researchoffice@imperial.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 062258)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2003 results in https://www.ncbi.nlm.nih.gov/pubmed/14525636 (added 14/02/2020)