The role of hypovolaemia In the acidosis of severe malaria in children

ISRCTN ISRCTN58063971
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

KEMRI
KEMRI Centre for Geographic Medicine
P.O. Box 230
Kilifi
-
Kenya

Phone +254 (0)73 3411022
Email kmaitland@kilifi.mimcom.net

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe role of hypovolaemia In the acidosis of severe malaria in children
Study objectives1. 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) studiedSevere malaria
InterventionOpen 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 typeOther
Primary outcome measurePercentage reduction in acidosis by eight hours.
Secondary outcome measures1. Death
2. Severe adverse events
3. Neurological sequalae
Overall study start date01/05/2001
Completion date01/10/2002

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants53
Total final enrolment53
Key inclusion criteria1. 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 criteria1. 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 enrolment01/05/2001
Date of final enrolment01/10/2002

Locations

Countries of recruitment

  • Kenya

Study participating centre

KEMRI
Kilifi
-
Kenya

Sponsor information

Imperial College London (UK)
University/education

Level 2, Faculty Building
Clinical Research Office
South Kensington campus
London
SW7 2AZ
England
United Kingdom

Email clinical.researchoffice@imperial.ac.uk
Website http://www3.imperial.ac.uk/
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.