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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.]

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of operation to discharge from the post anesthesia care unit (pacu)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with fluid responsiveness

Secondary outcome measures

Maternal blood pressure (diastolic)

Maternal blood pressure (systolic)

Number of adverse events

+2 more

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

905 Previous Clinical Trials

321,048 Total Patients Enrolled

Onyi Onuoha, MD, MPHPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA officially sanctioned Fluid replacement by means of colloid as instructed through Stroke Volume Variation (SVV)?

"A score of 3 has been assigned to the safety profile of fluid replacement using colloid as guided by stroke volume variation (SVV) due to it being a Phase 4 trial, indicating its approval."

Answered by AI

Are there any remaining vacancies for individuals in this trial?

"According to the information on clinicaltrials.gov, this medical study is not presently recruiting participants. It was first published in November 1st 2023 and last revised October 24th 2023; however, there are currently 93 other trials actively looking for patients at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Onyi C Onuoha 2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06107335.

All > Preeclampsia