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Hypertonic Saline Use in Preeclampsia

Primary Purpose

Preeclampsia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
2% buffered hypertonic saline administration
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preeclampsia focused on measuring preeclampsia, hypertonic saline, diuresis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Johns Hopkins University Hospital
  • Johns Hopkins Bayview Medical Center

Outcomes

Primary Outcome Measures

Fluid input to output ratios

Secondary Outcome Measures

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

Full Information

First Posted
September 10, 2005
Last Updated
September 21, 2012
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT00181077
Brief Title
Hypertonic Saline Use in Preeclampsia
Official Title
Hypertonic Saline Use for Volume Expansion in Postpartum Preeclampsia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Our patient population will consist of postpartum women who were diagnosed with preeclampsia in the antepartum period. Our goal is to enroll ten patients in the treated group and ten patients in the control group. The treatment group will have a 2% buffered hypertonic saline solution infused at 30 mL/hr in addition to receiving magnesium sulfate for seizure prophylaxis. The control group will receive the currently practiced regimen of infusion of a Lactated Ringer's solution at 75cc/hr. Both groups will be monitored on our Labor and Delivery unit as is the norm for any patient on a magnesium sulfate infusion. They will receive routine nursing care and hourly collaborative team assessments by the nurses and the physicians for signs of magnesium toxicity. Urine input/output ratios are evaluated on an hourly basis and a lung examination is performed to assess for pulmonary edema. A pulse oximeter will be used to obtain an hourly assessment of the patient's oxygenation status. Both groups will have blood work evaluation every six hours for platelet count, electrolytes, liver enzymes, interleukin-1 and interleukin-6 (as markers of inflammation). We will collect information on patient symptoms regarding headache, visual changes and epigastric pain at 4-hour intervals and obtain the patient's weight immediately postpartum as well as at 24-hour intervals. Magnesium sulfate infusions will be discontinued at 24 hours postpartum or later at the discretion of the treating physician. No antihypertensive medications will be withheld from either group. Blood pressure will be obtained in the patients at the current interval of 60 minutes. Hypertonic saline will be infused until the patient is 24 hours postpartum. Our primary outcome variable is the ratio of fluid intake to urine output. Data will be collected during the length of stay on our Labor and Delivery unit before the patient meets criteria for transfer to our postpartum unit, and their overall hospital stay.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
preeclampsia, hypertonic saline, diuresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
2% buffered hypertonic saline administration
Primary Outcome Measure Information:
Title
Fluid input to output ratios
Secondary Outcome Measure Information:
Title
laboratory evaluation of inflammatory parameters (platelet count, IL-1, IL-6), liver enzymes, weight

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abimbola Aina-Mumuney, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
Country
United States

12. IPD Sharing Statement

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Hypertonic Saline Use in Preeclampsia

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