The role of hypovolaemia In the acidosis of severe malaria in children
ISRCTN | ISRCTN58063971 |
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DOI | https://doi.org/10.1186/ISRCTN58063971 |
Secondary identifying numbers | 062258 |
- Submission date
- 22/07/2005
- Registration date
- 22/07/2005
- Last edited
- 14/02/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Kathryn Maitland
Scientific
Scientific
KEMRI
KEMRI Centre for Geographic Medicine
P.O. Box 230
Kilifi
-
Kenya
Phone | +254 (0)73 3411022 |
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kmaitland@kilifi.mimcom.net |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | The role of hypovolaemia In the acidosis of severe malaria in children |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | Percentage reduction in acidosis by eight hours. |
Secondary outcome measures | 1. Death 2. Severe adverse events 3. Neurological sequalae |
Overall study start date | 01/05/2001 |
Completion date | 01/10/2002 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 53 |
Total final enrolment | 53 |
Key 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 |
Key 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 |
Date of first enrolment | 01/05/2001 |
Date of final enrolment | 01/10/2002 |
Locations
Countries of recruitment
- Kenya
Study participating centre
KEMRI
Kilifi
-
Kenya
-
Kenya
Sponsor information
Imperial College London (UK)
University/education
University/education
Level 2, Faculty Building
Clinical Research Office
South Kensington campus
London
SW7 2AZ
England
United Kingdom
clinical.researchoffice@imperial.ac.uk | |
Website | http://www3.imperial.ac.uk/ |
https://ror.org/041kmwe10 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 062258)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/10/2003 | 14/02/2020 | Yes | No |
Editorial Notes
14/02/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.