Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): (PRESIDEX)
This is a double blinded, placebo-controlled trial to determine if IV dexamethasone more quickly than placebo assists resolution of Posterior Reversible Encephalopathy Syndrome (PRES) encountered in eclamptic patients. All patients regardless of assignment to placebo or steroid will receive standard therapy to include magnesium sulfate, blood pressure medications and diuretics. We hypothesize that the addition of dexamethasone to standard therapy will accelerate CNS recovery more quickly than standard management without dexamethasone.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): A Randomized Clinical Trial Evaluating Corticosteroid Efficacy to Augment Standard Therapy and Shorten Recovery.|
- Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): Arandomized clinical trial evaluating corticosteroid efficacy to augment standard therapy and shorten recovery [ Time Frame: 36 months ] [ Designated as safety issue: No ]To learn if giving IV dexamethasone to eclamptic women with PRES will accelerate normalization of CNS function.
|Study Start Date:||February 2012|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Dexamethasone
Dexamethasone 12 mg, 2 doses, 12 hours apart.
Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart
Other Name: Potent glucocorticoid or steroid
Placebo Comparator: Placebo
Placebo, 2 doses, 12 hours apart
30 eclamptic patients who do not require steroids for fetal lung maturation purposes will be randomized to placebo or steroid. This includes patients with eclampsia encountered antepartum prior to 23 weeks gestation, postpartum eclampsia, undelivered patients encountered after 33 weeks gestation who would not be candidates for fetal lung maturation steroids, or patients not eligible for repeat steroid administration in the 23-34 week gestational window. Planned enrollment in this pilot study is up to 30 patients with at least 12 in each group.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02027272
|United States, Mississippi|
|University of Mississippi Medical Center|
|Jackson, Mississippi, United States, 39216|
|Principal Investigator:||James Martin, MD||University of Mississippi Medican Center|