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

ISRCTN	ISRCTN58063971
DOI	https://doi.org/10.1186/ISRCTN58063971
Protocol serial number	062258
Sponsor	Imperial College London (UK)
Funder	The Wellcome Trust (UK) (grant ref: 062258)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Percentage reduction in acidosis by eight hours.
Key secondary outcome measure(s)	1. Death 2. Severe adverse events 3. Neurological sequalae
Completion date	01/10/2002

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

KEMRI

Kilifi
-
Kenya

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2003	14/02/2020	Yes	No

14/02/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.