Hypertonic Saline Use in Preeclampsia
|Preeclampsia||Drug: 2% buffered hypertonic saline administration||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Hypertonic Saline Use for Volume Expansion in Postpartum Preeclampsia|
- Fluid input to output ratios
- laboratory evaluation of inflammatory parameters (platelet count, IL-1, IL-6), liver enzymes, weight
|Study Start Date:||June 2003|
|Study Completion Date:||April 2006|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00181077
|United States, Maryland|
|Johns Hopkins University Hospital|
|Baltimore, Maryland, United States, 21287|
|Johns Hopkins Bayview Medical Center|
|Baltimore, Maryland, United States|
|Principal Investigator:||Abimbola Aina-Mumuney, MD||Johns Hopkins University|