PreeclampsiaPhase 1NCT00181077
Hypertonic Saline Use in Preeclampsia
A Phase 1 study testing 2% buffered hypertonic saline administration in people with Preeclampsia, run by Johns Hopkins University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- 2% buffered hypertonic saline administration
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2003to Apr 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University Hospital
Baltimore, Maryland, 21287
Johns Hopkins Bayview Medical Center
Baltimore, Maryland
About this study
Official title: Hypertonic Saline Use for Volume Expansion in Postpartum Preeclampsia
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.
Read the 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.
- Conditions
- Preeclampsia
- Being tested
- 2% buffered hypertonic saline administration
- Keywords
- preeclampsia, hypertonic saline, diuresis
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% buffered hypertonic saline administrationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid input to output ratios
Secondary outcomes (1)
laboratory evaluation of inflammatory parameters (platelet count, IL-1, IL-6), liver enzymes, weight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abimbola Aina, Johns Hopkins University
- Investigators
- Abimbola Aina-Mumuney, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181077
- Sponsor's protocol ID
- 03--03-13-06
- Status last verified
- Sep 2012
- First submitted
- 10 Sep 2005
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertonic Saline Use for Volume Expansion in Postpartum Preeclampsia
- ClinicalTrials.gov ID
- NCT00181077
- Acronym / sponsor ID
- 03--03-13-06
- Conditions
- Preeclampsia
- Keywords
- preeclampsia, hypertonic saline, diuresis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2% buffered hypertonic saline administration | Drug | – |
Primary outcome
Fluid input to output ratios
1 secondary outcome
laboratory evaluation of inflammatory parameters (platelet count, IL-1, IL-6), liver enzymes, weight
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2012.
Related trials for Preeclampsia
RecruitingPhase 4
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Hypertensive Disorders of Pregnancy, Preeclampsia
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, Preeclampsia
Not yet recruiting
Usability Evaluation of Gen AI-based Nutrition Chatbot for Pregnant Women
Diabetes, Gestational, Pre-eclampsia
RecruitingPhase 4
AtorvaStatin Postpartum and Reduction of Cardiovascular risK
Hypertensive Disorders of Pregnancy, Preeclampsia
Not yet recruiting
A Randomized Trial to Reduce Blood Pressure at One Year Postpartum After Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abimbola Aina-Mumuney, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 2% buffered hypertonic saline administration in people with Preeclampsia, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid input to output ratios. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2012.