Trial record 7 of 258 for:    eclampsia

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

This study has been terminated.
(Difficulty recruiting, only one participant in 18 months, rarity of event)
Sponsor:
Information provided by (Responsible Party):
James Martin, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT02027272
First received: January 15, 2013
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Eclampsia
Drug: Dexamethasone

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • 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.


Enrollment: 1
Study Start Date: February 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexamethasone
Dexamethasone 12 mg, 2 doses, 12 hours apart.
Drug: Dexamethasone
Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart
Other Name: Potent glucocorticoid or steroid
Placebo Comparator: Placebo
Placebo, 2 doses, 12 hours apart

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02027272

Locations
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
Principal Investigator: James Martin, MD University of Mississippi Medican Center
  More Information

No publications provided

Responsible Party: James Martin, Professor, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT02027272     History of Changes
Other Study ID Numbers: 2011-0269
Study First Received: January 15, 2013
Last Updated: January 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:
Eclampsia

Additional relevant MeSH terms:
Eclampsia
Posterior Leukoencephalopathy Syndrome
Hypertension, Pregnancy-Induced
Pregnancy Complications
Hypertensive Encephalopathy
Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Leukoencephalopathies
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014