Albumin for Pre-eclampsia

Overseen By Barbara Orlando, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Labor, General anesthesia, Cardiopulmonary disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: During cesarean delivery

62 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment involving the Edwards HemoSphere monitor with ClearSight-Acumen finger cuff, Human Albumin, and Lactated Ringer's Injection for pre-eclampsia?

Research shows that using albumin as part of the treatment for pre-eclampsia does not effectively lower blood pressure or improve kidney function, and it does not lead to stable improvements in blood flow to the placenta. However, no maternal complications were observed, although fetal mortality was high in the study. ^{1 2 3 4 5}

Is albumin safe for use in humans?

In a study with pre-eclampsia patients, daily albumin infusions did not cause any maternal complications, although fetal mortality was high. This suggests that albumin is generally safe for the mother, but the study was uncontrolled, so results should be interpreted with caution. ^{2 6 7 8 9}

How does albumin treatment differ from other treatments for pre-eclampsia?

Albumin treatment for pre-eclampsia involves using albumin as a plasma expander to improve blood flow and reduce swelling, but it does not effectively lower blood pressure or improve kidney function compared to other treatments. Unlike standard antihypertensive therapies, albumin infusions do not show stable improvements in blood pressure or fetal outcomes. ^{1 2 4 9 10}

Research Team

Onyi Onuoha, MD, MPH

Principal Investigator

The University of Texas Health Science Center, Houston

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either albumin or routine care to manage hemodynamic response during cesarean delivery

During cesarean delivery

1 visit (in-person)

Immediate Post-Operative Monitoring

Participants are monitored for fluid responsiveness and hemodynamic stability from baseline to thirty minutes after arrival to the Post Anesthesia Care Unit (PACU)

30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• Edwards HemoSphere monitor with ClearSight-Acumen finger cuff
• Human Albumin
• Lactated Ringer's Injection

Trial Overview 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.

Participant Groups

Group I: Fluid replacement using colloid as guided by stroke volume variation (SVV) Experimental Treatment 2 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 crystalloid Active Control 1 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).

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Maternal and perinatal outcome of temporizing management in 254 consecutive patients with severe pre-eclampsia remote from term. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Repeated albumin infusions do not lower blood pressure in preeclampsia. [2004]

3. India pubmed.ncbi.nlm.nih.gov

Association of hypoproteinemia in preeclampsia with maternal and perinatal outcomes: A retrospective analysis of high-risk women. [2020]

4. England pubmed.ncbi.nlm.nih.gov

The importance of proteinuria in preeclampsia and its predictive role in maternal and neonatal outcomes. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Protocol for measurement of mean arterial pressure at 11-13 weeks' gestation. [2012]

6. England pubmed.ncbi.nlm.nih.gov

Role of placental, fetal and maternal cardiovascular markers in predicting adverse outcome in women with suspected or confirmed pre-eclampsia. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Distribution and elimination of crystalloid fluid in pre-eclampsia. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

[Hypervolemic hemodilution in pre-eclampsia]. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Treatment of pre-eclampsia and eclampsia as a hypoperfusion syndrome. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

The Momedemameter: An Affordable Preeclampsia Detector For Low Resource Environments. [2021]