Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113854
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2005-06-10
Brief Title:
Mannitol as Adjunct Therapy for Childhood Cerebral Malaria
Sponsor:
Makerere University
Organization:
Makerere University
Study Overview
Official Title:
Effect of Mannitol as Adjunct Therapy on the Clinical Outcome of Childhood Cerebral Malaria in Mulago Hospital A Randomised Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2005-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cerebral malaria is a life-threatening complication of Plasmodium falciparum infection in African children and nonimmune travellers despite availability of quinine the current drug of choice Several reports have suggested that raised intracranial pressure ICP is a major cause of death among children with cerebral malaria Mannitol an osmotic diuretic effectively lowers ICP and is used to treat post traumatic raised ICP There have been some case reports of reduction in mortality and morbidity in African children with cerebral malaria following administration of mannitol but as these were not randomized controlled trials it is difficult to evaluate their significance This study seeks to establish whether a single dose of intravenous mannitol given to children with cerebral malaria will significantly reduce the coma recovery time
Detailed Description:
Cerebral malaria is a life-threatening complication of Plasmodium falciparum infection accounting for significant morbidity and mortality in African children despite availability of quinine the current drug of choice The case fatality ranges from 5 to 40 with almost 10 of survivors experiencing neurological sequelae
Several reports have suggested that raised intracranial pressure ICP may be a feature of cerebral malaria There is evidence of brain swelling on computer tomography magnetic resonance imaging and at necropsy It has been postulated that raised intracranial pressure can cause death by transtentorial herniation or by compromising cerebral blood flow In fact most children who died of cerebral malaria in a Kenyan study had clinical signs compatible with transtentorial herniation and all those who had severe ICP maximum ICP 40mmHg either died or survived with neurological sequelae
Mannitol an osmotic diuretic effectively lowers ICP and is used to treat post traumatic raised intracranial pressure There have been some case reports of reduction in mortality and morbidity in African children with cerebral malaria following administration of mannitol but as these were not randomized controlled trials it is difficult to evaluate their significance Currently the WHO contends that there is insufficient evidence for using mannitol as adjunct therapy for cerebral malaria
A recent Cochrane review found no randomized or quasi-randomized controlled trial to support or refute the use of mannitol as adjunct therapy for cerebral malaria
Hypothesis A single dose of intravenous mannitol 1gkg given to children with cerebral malaria will reduce mean coma recovery time from 225 to 131 hours
We calculated a sample size of 78 patients in each group for 90 power and 95 confidence In the calculation we assumed that the children receiving intravenous mannitol would have a mean coma recovery time of 131 SD 185 hours and those receiving placebo would have a mean coma recovery time of 225 SD 185 hours 423 effect size according to a recent study by Aceng Byarugaba and Tumwine in the same hospital
Several reports have suggested that raised intracranial pressure ICP may be a feature of cerebral malaria There is evidence of brain swelling on computer tomography magnetic resonance imaging and at necropsy It has been postulated that raised intracranial pressure can cause death by transtentorial herniation or by compromising cerebral blood flow In fact most children who died of cerebral malaria in a Kenyan study had clinical signs compatible with transtentorial herniation and all those who had severe ICP maximum ICP 40mmHg either died or survived with neurological sequelae
Mannitol an osmotic diuretic effectively lowers ICP and is used to treat post traumatic raised intracranial pressure There have been some case reports of reduction in mortality and morbidity in African children with cerebral malaria following administration of mannitol but as these were not randomized controlled trials it is difficult to evaluate their significance Currently the WHO contends that there is insufficient evidence for using mannitol as adjunct therapy for cerebral malaria
A recent Cochrane review found no randomized or quasi-randomized controlled trial to support or refute the use of mannitol as adjunct therapy for cerebral malaria
Hypothesis A single dose of intravenous mannitol 1gkg given to children with cerebral malaria will reduce mean coma recovery time from 225 to 131 hours
We calculated a sample size of 78 patients in each group for 90 power and 95 confidence In the calculation we assumed that the children receiving intravenous mannitol would have a mean coma recovery time of 131 SD 185 hours and those receiving placebo would have a mean coma recovery time of 225 SD 185 hours 423 effect size according to a recent study by Aceng Byarugaba and Tumwine in the same hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None