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Albumin for Pre-eclampsia

Phase 4

Waitlist Available

Led By Onyi Onuoha, MD, MPH

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Requiring Neuraxial Anesthesia (spinal or CSE)

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.]

Must not have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to thirty minutes after arrival to the post anesthesia care unit (pacu)

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial studies if using albumin to replace volume during c-section in pre-eclamptic patients leads to better hemodynamic stability than usual care.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of human albumin include allergic reactions, fluid overload leading to heart or lung problems, and electrolyte imbalances. The ClearSight-Acumen monitor is non-invasive but may cause discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need spinal or combined spinal-epidural anesthesia.

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I have been diagnosed with severe preeclampsia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have spinal or epidural anesthesia due to certain health issues.

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

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I will be using or switching to general anesthesia.

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I have a serious heart or lung condition.

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I choose not to participate in this study.

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I needed many blood transfusions and ICU care due to surgery complications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to thirty minutes after arrival to the post anesthesia care unit (pacu)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to thirty minutes after arrival to the post anesthesia care unit (pacu)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to thirty minutes after arrival to the post anesthesia care unit (pacu) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with fluid responsiveness

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

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).

0 / 8Eligibility criteria met