Albumin for Pre-eclampsia

Recruiting in Palo Alto (17 mi)

Overseen byOnyi Onuoha, MD, MPH

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: The University of Texas Health Science Center, Houston

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to compare the effect of albumin versus routine care on hemodynamic response and stability in pre-eclamptic patients during cesarean delivery. The hypothesis is that volume replacement with albumin guided by stroke volume variation (SVV) using a ClearSight-Acumen (CS-A) monitor, before cesarean delivery (CD), improves hemodynamic stability in preeclamptic patients with severe features compared to routine care, under neuraxial anesthesia.

Eligibility Criteria

This trial is for pregnant women at least 24 weeks along, needing a scheduled C-section under spinal anesthesia, and diagnosed with severe preeclampsia. It's not for those in labor, with conditions that prevent spinal anesthesia use, or requiring immediate surgery due to life-threatening issues.

Inclusion Criteria

I am having an urgent C-section not immediately life-threatening within 30 minutes.

You are booked for a Cesarean Delivery.

Your gestational age is at least 24 weeks.

+2 more

Exclusion Criteria

I will be using or switching to general anesthesia.

I have a serious heart or lung condition.

I need an emergency C-section to save my life or my baby's.

+5 more

Participant Groups

The study tests if giving albumin (a blood protein) helps maintain stable blood pressure and heart function during a C-section in patients with severe preeclampsia. This is compared to routine care, guided by non-invasive hemodynamic monitoring.

2Treatment groups

Experimental Treatment

Active Control

Group I: Fluid replacement using colloid as guided by stroke volume variation (SVV)Experimental Treatment2 Interventions

Fluid replacement will be achieved with the colloid 5% albumin infusion. Use of colloid will be guided by stroke volume variation (SVV) as assessed by the Edwards HemoSphere monitor with ClearSight-Acumen finger cuff device.

Group II: Fluid restriction using crystalloidActive Control1 Intervention

Fluid restriction will be achieved with the crystalloid lactated ringer's injection administered at at a keep-the-vein-open (KVO) rate of 75 milliliters per hour (mL/hr).