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Albumin vs. Routine Care for Preeclampsia During C-Section

This study is looking at how different fluid treatments affect women with preeclampsia (high blood pressure during pregnancy) who are having a C-section with spinal anesthesia. Researchers are comparing two approaches: giving 5% Albumin (a fluid replacement) guided by a special monitor (Edwards HemoSphere) to track your body's response, versus routine care which uses Lactated Ringer's Injection (another type of fluid). The goal is to see if Albumin helps keep your blood pressure and circulation more stable. You may be able to join if you are at least 18 years old, at least 24 weeks pregnant, and have preeclampsia with severe features. The study aims to enroll 62 participants. Success will be measured by how many participants show a good fluid response after treatment and up to 30 minutes after arriving in the recovery room. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 62 women to compare two different fluid treatments during C-section for preeclampsia.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored from baseline up to 30 minutes after arriving in the Post Anesthesia Care Unit (PACU).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06107335

Effect of Albumin Versus Routine Care on Hemodynamic Response and Stability in Patients With Preeclampsia Guided by a Non-invasive Hemodynamic Monitoring System During Cesarean Delivery With Spinal Anesthesia

Not Yet Recruiting
PHASE4Ages 18+InterventionalPrevention
The University of Texas Health Science Center, Houston
~62 participants
Updated 2024-12-06 on ClinicalTrials.gov
What's tested:Human Albumin (colloid)Lactated Ringer's Injection (crystalloid)Edwards HemoSphere monitor with ClearSight-Acumen finger cuff

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with fluid responsiveness
Measured over from baseline to thirty minutes after arrival to the Post Anesthesia Care Unit (PACU)

Conditions

Pre-Eclampsia

Explore related trials

Preeclampsia

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Onyi Onuoha, MD, MPH · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

Barbara Orlando, MD
[email protected]
917-496-7490
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Gestational age greater or equal to 24 weeks
Diagnosis of preeclampsia with severe features \[Pre-eclampsia is defined as high blood pressure after 20 weeks with or without proteinuria. Pre-eclampsia with severe features is defined as the presence of preeclampsia with any of the following features: severe hypertension (blood pressure ≥160/110 mmHg on two separate occasions); thrombocytopenia (platelet count \<100,000 per microliter); impaired liver function (elevated liver transaminases to twice the normal concentration or severe persistent right upper quadrant or epigastric pain not responsive to medications); progressive renal insufficiency with a serum creatinine level of \>1.1 mg/dl or doubling of the serum creatinine level in the absence of other renal disease; pulmonary edema or unexplained new-onset cerebral symptoms (headache) unresponsive to medications or visual disturbances.\]
Scheduled Cesarean Delivery
Unscheduled Cesarean Delivery with the goal to proceed to the operating room within no less than 30 minutes due to concern for maternal or fetal status that is not immediately life threatening.
Requiring Neuraxial Anesthesia (spinal or CSE)

Exclusion

Patient declines to participate in the study
Labor
Contraindications to the use of neuraxial anesthesia (coagulopathy, infection at the insertion site, intracranial mass etc.)
Unscheduled Cesarean Delivery with the goal to proceed to the operating room immediately for delivery of the baby due to imminent/unavoidable threat to the life of the mother or fetus.
The use of or conversion to General Anesthesia
Non-reassuring fetal status including the presence of cardiac or multi-system anomalies, category III tracing etc.
Significant maternal cardiopulmonary disease including pulmonary hypertension, ischemic heart disease with systolic dysfunction, pulmonary edema etc.
Significant intraoperative events (such as hemorrhage) requiring administration of multiple blood products and ICU admission.

What this trial measures

  • Number of participants with fluid responsivenessfrom baseline to thirty minutes after arrival to the Post Anesthesia Care Unit (PACU)

    "Fluid responsiveness" (in other words, a "positive response") is defined as a volume-induced correction to stroke volume variation (SVV) values \< 13%. SVV measurements will be made using the Edwards HemoSphere monitor with ClearSight-Acumen finger cuff.