Hypertonic Saline Use in Preeclampsia

NCT00181077 | Completed Phase 1

• 1 other identifier: 03--03-13-06
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

To compare hypertonic saline to Lactated Ringer's solution and assess whether one speeds up the process of getting rid of extra body water faster in women with preeclampsia.

Conditions

Preeclampsia

Keywords

preeclampsia, hypertonic saline, diuresis

Outcome Measures

Primary Outcomes (1)

• Fluid input to output ratios

Secondary Outcomes (1)

• laboratory evaluation of inflammatory parameters (platelet count, IL-1, IL-6), liver enzymes, weight

Interventions

2% buffered hypertonic saline administration DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women must have satisfied conditions for the diagnosis of preeclampsia (BP \> 140/90, proteinuria ≥ 2+ or 300 mg in 24 hours)
• Women must have creatinine level below 1.6 mg/dL
• Women must have delivered their infant(s) prior to initiating therapy
• Women must be English-speaking
• Women must be medically stable at the time of entry into the study
• Women must be over the legal consenting age of 18 years
• Women must be consented prior to the administration of narcotics or other medications that may interfere with ability to give informed consent
• If not consented at the time of admission to Labor and Delivery, women must be comfortable enough with their contractions to complete the informed consent process without duress, or must be comfortable with regional anesthesia
• Women on magnesium sulfate will be eligible for entry after assessment of level of consciousness is deemed sufficient to give informed consent

You may not qualify if:

• Women not able to understand the study because of language barriers or significant learning impairment
• Women less than 18 years of age
• Women who are medically unstable prior to recruitment or in whom expeditious delivery is warranted
• Women who have developed eclampsia (or seizures as a result of their preeclamptic condition)
• Women who have not consented prior to the administration of narcotics or other medications that may interfere with their ability to give informed consent
• Women whose pain severity in labor is such that they cannot participate in informed consent
• Women with a pre-existing cardiomyopathy
• Women with a sodium level \< 130, or \> 150 mEq/L
• Women with a creatinine level greater than 1.6 mg/dL
• Women with co-morbid conditions that affect renal function i.e. lupus nephritis, diabetic nephropathy, or pre-existing hypertensive kidney disease
• Women whose level of consciousness on magnesium sulfate is deemed insufficient to give informed consent

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (2)

Johns Hopkins University Hospital

Baltimore, Maryland, 21287, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Abimbola Aina-Mumuney, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 16, 2005
• Study Start: June 1, 2003
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: September 25, 2012

Record last verified: 2012-09

Locations

US (2)