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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a protein called albumin can stabilize blood pressure during cesarean deliveries in women with severe pre-eclampsia. Pre-eclampsia, characterized by high blood pressure after 20 weeks of pregnancy, can lead to serious health issues. The trial compares two methods: one group receives lactated Ringer's solution, while another group receives albumin, a type of colloid protein. Women who are at least 24 weeks pregnant, have severe pre-eclampsia, and require a cesarean delivery with specific types of anesthesia may be suitable candidates for this study. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how albumin benefits more patients.

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 is the safety track record for these treatments?

Research has shown that using human albumin in patients with pre-eclampsia is generally safe for mothers. One study found that daily albumin infusions did not cause any maternal problems. However, while the treatment was safe for mothers, concerns arose about the babies, with high rates of fetal death reported.

Another study identified a possible risk of human albumin causing transfusion-related acute lung injury, a serious lung condition. Despite this risk, the treatment has been tested in pre-eclampsia patients without major maternal issues.

Since this trial is in a later stage, earlier studies have tested the treatment's safety, deeming it acceptable for further testing. Always consult a healthcare provider to understand the risks and benefits before joining any clinical trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it explores innovative ways to manage fluid balance in patients with pre-eclampsia, a common pregnancy complication. Unlike typical treatments that often involve just crystalloid solutions like lactated Ringer's for fluid management, this trial uses advanced technology and a new approach with colloid solutions. The Edwards HemoSphere monitor with ClearSight-Acumen finger cuff offers real-time monitoring of stroke volume variation (SVV), guiding fluid replacement more precisely with 5% human albumin. This method could potentially optimize fluid management, reducing risks and improving outcomes for both mothers and babies.

What evidence suggests that this trial's treatments could be effective for pre-eclampsia?

Research shows that albumin, a protein in the blood, might help manage pre-eclampsia, a condition where pregnant women experience high blood pressure. Studies have found that people with pre-eclampsia often have lower levels of albumin due to inflammation and liver problems. Replacing albumin could help balance blood levels, potentially improving health outcomes for mothers and babies. In this trial, one group will receive fluid replacement using colloid 5% albumin infusion, guided by stroke volume variation (SVV) as assessed by the Edwards HemoSphere monitor with the ClearSight-Acumen finger cuff device. This will investigate whether using albumin during cesarean delivery can maintain stable blood flow in patients with pre-eclampsia. Another group will receive fluid restriction using crystalloid lactated ringer's injection at a keep-the-vein-open (KVO) rate. ^{6 7 8 9 10}

Who Is on the Research Team?

Onyi Onuoha, MD, MPH

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12248646/

Could Low Serum Albumin Level Be an Independent ... According to data from Table 7, we observed the following: No significant differences in albumin levels depending on gestational age at birth ...

2. nature.com nature.com/articles/s41598-025-01797-3

Evaluation of albumin-based inflammatory markers as ... Albumin levels tend to decrease in patients with HELLP syndrome due to systemic inflammatory responses and liver dysfunction, which contribute ...

3. researchgate.net researchgate.net/publication/339426809_Preliminary_study_of_human_serum_albumin_level_in_early_warning_onset_of_preeclampsia

Preliminary study of human serum albumin level in early ... ... It was demonstrated that decline in serum albumin levels could predict the development of preeclampsia [19] , while another study showed an ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5244641/

Association of hypoproteinemia in preeclampsia with maternal ... The aim of this study was to evaluate maternal and perinatal outcomes in preeclampsia (PE), according to the value of albumin.

5. journaljammr.com journaljammr.com/index.php/JAMMR/article/view/5077

Effect of Exogenous Albumin Replacement on Plasma ... Results: A significant decrease in plasma albumin was found (case group 2.72±0.44 vs 2.45±0.48 g/dL, p=0.0141; control group 3.06±0.33 vs 2.58± ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10825956/

Identifying new safety risk of human serum albumin This study has revealed that HSA poses a risk of causing transfusion-related acute lung injury. It has also been observed that adverse reactions, including ...

7. withpower.com withpower.com/trial/phase-4-pre-eclampsia-10-2023-7c2d4

Albumin for Pre-eclampsia · Info for Participants In a study with pre-eclampsia patients, daily albumin infusions did not cause any maternal complications, although fetal mortality was high. This suggests that ...

8. imrpress.com imrpress.com/journal/CEOG/31/3/pii/2004054/pdf

Plasma albumin level as an indicator of severity of ... Our data show that the lowest serum albumin levels were significantly associated to the more severe forms of preeclampsia. An abnormally low serum albumin level.

9. mdpi.com mdpi.com/2227-9032/13/13/1503

Could Low Serum Albumin Level Be an Independent ... These findings align with recent studies indicating that decreased serum albumin is associated with adverse fetal and maternal outcomes, including low birth ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT06107335

Effect of Albumin Versus Routine Care on Hemodynamic ... 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 ...