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Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): (PRESIDEX)

Primary Purpose

Eclampsia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
University of Mississippi Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eclampsia focused on measuring Eclampsia

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Currently 34 weeks pregnant or within 6 weeks postpartum
  2. At least 18 years of age
  3. Singleton or twin gestation
  4. Patient or family sign informed consent
  5. Diagnosis of eclampsia
  6. Able to obtain MRI scanning within 24hours of hosp admit and/or seizure

Exclusion Criteria:

  1. Neither pregnant nor within first 6 weeks postpartum
  2. Patient or family unable to sign informed consent
  3. Less than 18 years of age
  4. Triplet or higher order gestation
  5. Unable to obtain MRI scanning within 24 hours of hospital admission (
  6. Diagnosis of cerebral hemorrhage
  7. Patient in whom MRI is contraindicated

Sites / Locations

  • University of Mississippi Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexamethasone

Placebo

Arm Description

Dexamethasone 12 mg, 2 doses, 12 hours apart.

Placebo, 2 doses, 12 hours apart

Outcomes

Primary Outcome Measures

Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): Arandomized Clinical Trial Evaluating Corticosteroid Efficacy to Augment Standard Therapy and Shorten Recovery
To learn if giving IV dexamethasone to eclamptic women with PRES will accelerate normalization of CNS function.

Secondary Outcome Measures

Full Information

First Posted
January 15, 2013
Last Updated
April 19, 2016
Sponsor
University of Mississippi Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02027272
Brief Title
Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES):
Acronym
PRESIDEX
Official Title
Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): A Randomized Clinical Trial Evaluating Corticosteroid Efficacy to Augment Standard Therapy and Shorten Recovery.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Difficulty recruiting, only one participant in 18 months, rarity of event
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mississippi Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eclampsia
Keywords
Eclampsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Dexamethasone 12 mg, 2 doses, 12 hours apart.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, 2 doses, 12 hours apart
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Potent glucocorticoid or steroid
Intervention Description
Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart
Primary Outcome Measure Information:
Title
Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): Arandomized Clinical Trial Evaluating Corticosteroid Efficacy to Augment Standard Therapy and Shorten Recovery
Description
To learn if giving IV dexamethasone to eclamptic women with PRES will accelerate normalization of CNS function.
Time Frame
36 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Currently 34 weeks pregnant or within 6 weeks postpartum At least 18 years of age Singleton or twin gestation Patient or family sign informed consent Diagnosis of eclampsia Able to obtain MRI scanning within 24hours of hosp admit and/or seizure Exclusion Criteria: Neither pregnant nor within first 6 weeks postpartum Patient or family unable to sign informed consent Less than 18 years of age Triplet or higher order gestation Unable to obtain MRI scanning within 24 hours of hospital admission ( Diagnosis of cerebral hemorrhage Patient in whom MRI is contraindicated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Martin, MD
Organizational Affiliation
University of Mississippi Medican Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES):

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