Hypertonic Saline Use in Preeclampsia - Full Text View

Sponsored by:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00181077

Purpose

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.

Condition	Intervention	Phase
Preeclampsia	Drug: 2% buffered hypertonic saline administration	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Hypertonic Saline Use for Volume Expansion in Postpartum Preeclampsia

Further study details as provided by Johns Hopkins University:

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

Estimated Enrollment:	20
Study Start Date:	June 2003
Estimated Study Completion Date:	April 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181077

Locations

United States, Maryland
Johns Hopkins University Hospital
Baltimore, Maryland, United States, 21287
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:

Abimbola Aina-Mumuney, MD

Johns Hopkins University

More Information

Study ID Numbers:	03--03-13-06
Study First Received:	September 10, 2005
Last Updated:	May 23, 2006
ClinicalTrials.gov Identifier:	NCT00181077
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

preeclampsia, hypertonic saline, diuresis

Study placed in the following topic categories:

Hypertension, Pregnancy-Induced
Pregnancy Complications
Eclampsia
Pregnancy toxemia /hypertension

Pre-Eclampsia
Preeclampsia
Hypertension

ClinicalTrials.gov processed this record on January 16, 2009