Pre-EclampsiaPhase 4NCT06107335
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
A Phase 4 study testing Human Albumin (colloid), Lactated Ringer's Injection (crystalloid) and Edwards HemoSphere monitor with ClearSight-Acumen finger cuff in people with Pre-Eclampsia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- Human Albumin (colloid), Lactated Ringer's Injection (crystalloid) and Edwards HemoSphere monitor with ClearSight-Acumen finger cuff
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 1 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gestational age greater or equal to 24 weeks
- 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.]
- Scheduled Cesarean Delivery
- Unscheduled Cesarean Delivery with the goal to proceed to the operating room within no less than 30 minutes due to concern for maternal or fetal status that is not immediately life threatening.
- Requiring Neuraxial Anesthesia (spinal or CSE)
Who cannot join
- Patient declines to participate in the study
- Labor
- 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.
- The use of or conversion to General Anesthesia
- Non-reassuring fetal status including the presence of cardiac or multi-system anomalies, category III tracing etc.
- Significant maternal cardiopulmonary disease including pulmonary hypertension, ischemic heart disease with systolic dysfunction, pulmonary edema etc.
- Significant intraoperative events (such as hemorrhage) requiring administration of multiple blood products and ICU admission.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Barbara Orlando, MD, 917-496-7490, barbara.orlando@uth.tmc.edu
About this study
Official title: 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 - A Randomized Controlled Study
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.
- Conditions
- Pre-Eclampsia
- Being tested
- Human Albumin (colloid), Lactated Ringer's Injection (crystalloid), Edwards HemoSphere monitor with ClearSight-Acumen finger cuff
- Keywords
- Pre-Eclampsia, Albumin, Hemodynamic
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Albumin (colloid)Drug
Also called Albutein
Fluid replacement will be achieved with colloid (5% albumin infusion). A bolus infusion of up to 500 milliliters (mL) of 5% Albumin will be administered prior to the placement of neuraxial anesthesia. If stroke volume variation (SVV) drops to less than 13% during the infusion of albumin, the infusion will be halted. At the completion of the placement of the spinal/combined spinal-epidural (CSE) anesthesia, study participants will receive the remaining albumin infusion if it was initially halted and SVV increases back to >13% during the procedure (to a total maximum of 500 mL albumin for the entire procedure).
Lactated Ringer's Injection (crystalloid)Drug
Fluid restriction will be achieved with crystalloid (lactated ringer's injection) administered at a keep-the-vein-open (KVO) rate of 75 milliliters per hour (mL/hr), administered during the procedure.
Edwards HemoSphere monitor with ClearSight-Acumen finger cuffDevice
Use of colloid will be guided by stroke volume variation (SVV) as assessed by the Edwards HemoSphere monitor with ClearSight-Acumen finger cuff device. The Edwards HemoSphere monitor with ClearSight-Acumen (CSA) finger cuff is a hemodynamic monitoring system that obtains continuous blood pressure readings from a cuff on the finger. In study participants, the finger cuff will be placed on the middle finger of one of the hands. The Edwards device can be used to predict impending intraoperative hypotension before its occurrence. The device has the ability to assess vasodilatory status using systemic vascular resistance (SVR), volume status using stroke volume variation (SVV) and stroke volume (SV) and the use of Carbon Monoxide (CO) to assess for underlying cardiac suppression. It also incorporates the hypotension prediction index (HPI), an algorithm that uses the arterial waveform to predict early phases of intraoperative hypotension.
| Study group | Role | What they receive |
|---|---|---|
| Fluid restriction using crystalloid | Active comparator | 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). Receives: Drug: Lactated Ringer's Injection (crystalloid) |
| Fluid replacement using colloid as guided by stroke volume variation (SVV) | Experimental | 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. Receives: Drug: Human Albumin (colloid); Device: Edwards HemoSphere monitor with ClearSight-Acumen finger cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with fluid responsiveness
"Fluid responsiveness" (in other words, a "positive response") is defined as a volume-induced correction to stroke volume variation (SVV) values < 13%. SVV measurements will be made using the Edwards HemoSphere monitor with ClearSight-Acumen finger cuff.
Measured: from baseline to thirty minutes after arrival to the Post Anesthesia Care Unit (PACU)
Secondary outcomes (5)
Number of participants with fluid responsiveness stability
Measured: from baseline to thirty minutes after arrival to the Post Anesthesia Care Unit (PACU)
Maternal blood pressure (diastolic)
Measured: baseline, after infusion of study intervention, at completion of placement of the spinal/CSE anesthesia, at completion of delivery of the baby, at end of procedure when leave operating room, thirty minutes after arrival to PACU
Maternal blood pressure (systolic)
Measured: baseline, after infusion of study intervention, at completion of placement of the spinal/CSE anesthesia, at completion of delivery of the baby, at end of procedure when leave operating room, thirty minutes after arrival to PACU
Total amount in milligrams of rescue vasopressor drug given
Measured: from start of operation to thirty minutes after arrival to the Post Anesthesia Care Unit (PACU)
Number of adverse events
Measured: from start of operation to discharge from the Post Anesthesia Care Unit (PACU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Jul 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onyi C Onuoha, The University of Texas Health Science Center, Houston
- Investigators
- Onyi Onuoha, MD, MPH, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107335
- Sponsor's protocol ID
- HSC-MS-23-0090
- Status last verified
- Dec 2024
- First submitted
- 24 Oct 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 - A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06107335
- Acronym / sponsor ID
- HSC-MS-23-0090
- Conditions
- Pre-Eclampsia
- Keywords
- Pre-Eclampsia, Albumin, Hemodynamic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluid restriction using crystalloid | Active comparator | Drug: Lactated Ringer's Injection (crystalloid)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). |
| Fluid replacement using colloid as guided by stroke volume variation (SVV) | Experimental | Drug: Human Albumin (colloid), Device: Edwards HemoSphere monitor with ClearSight-Acumen finger cuffFluid 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Gestational age greater or equal to 24 weeks
- 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.]
- Scheduled Cesarean Delivery
- Unscheduled Cesarean Delivery with the goal to proceed to the operating room within no less than 30 minutes due to concern for maternal or fetal status that is not immediately life threatening.
- Requiring Neuraxial Anesthesia (spinal or CSE)
Key exclusion criteria (8 listed)
- Patient declines to participate in the study
- Labor
- 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.
- The use of or conversion to General Anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Albumin (colloid)Also: AlbuteinFluid replacement will be achieved with colloid (5% albumin infusion). A bolus infusion of up to 500 milliliters (mL) of 5% Albumin will be administered prior to the placement of neuraxial anesthesia. If stroke volume variation (SVV) drops to less than 13% during the infusion of albumin, the infusion will be halted. At the completion of the placement of the spinal/combined spinal-epidural (CSE) anesthesia, study participants will receive the remaining albumin infusion if it was initially halted and SVV increases back to >13% during the procedure (to a total maximum of 500 mL albumin for the entire procedure). | Drug | Fluid replacement using colloid as guided by stroke volume variation (SVV) |
| Lactated Ringer's Injection (crystalloid)Fluid restriction will be achieved with crystalloid (lactated ringer's injection) administered at a keep-the-vein-open (KVO) rate of 75 milliliters per hour (mL/hr), administered during the procedure. | Drug | Fluid restriction using crystalloid |
| Edwards HemoSphere monitor with ClearSight-Acumen finger cuffUse of colloid will be guided by stroke volume variation (SVV) as assessed by the Edwards HemoSphere monitor with ClearSight-Acumen finger cuff device. The Edwards HemoSphere monitor with ClearSight-Acumen (CSA) finger cuff is a hemodynamic monitoring system that obtains continuous blood pressure readings from a cuff on the finger. In study participants, the finger cuff will be placed on the middle finger of one of the hands. The Edwards device can be used to predict impending intraoperative hypotension before its occurrence. The device has the ability to assess vasodilatory status using systemic vascular resistance (SVR), volume status using stroke volume variation (SVV) and stroke volume (SV) and the use of Carbon Monoxide (CO) to assess for underlying cardiac suppression. It also incorporates the hypotension prediction index (HPI), an algorithm that uses the arterial waveform to predict early phases of intraoperative hypotension. | Device | Fluid replacement using colloid as guided by stroke volume variation (SVV) |
Primary outcome
Number of participants with fluid responsiveness
Time frame: from baseline to thirty minutes after arrival to the Post Anesthesia Care Unit (PACU)
"Fluid responsiveness" (in other words, a "positive response") is defined as a volume-induced correction to stroke volume variation (SVV) values < 13%. SVV measurements will be made using the Edwards HemoSphere monitor with ClearSight-Acumen finger cuff.
5 secondary outcomes
Number of participants with fluid responsiveness stability
Time frame: from baseline to thirty minutes after arrival to the Post Anesthesia Care Unit (PACU)
Maternal blood pressure (diastolic)
Time frame: baseline, after infusion of study intervention, at completion of placement of the spinal/CSE anesthesia, at completion of delivery of the baby, at end of procedure when leave operating room, thirty minutes after arrival to PACU
Maternal blood pressure (systolic)
Time frame: baseline, after infusion of study intervention, at completion of placement of the spinal/CSE anesthesia, at completion of delivery of the baby, at end of procedure when leave operating room, thirty minutes after arrival to PACU
Total amount in milligrams of rescue vasopressor drug given
Time frame: from start of operation to thirty minutes after arrival to the Post Anesthesia Care Unit (PACU)
Number of adverse events
Time frame: from start of operation to discharge from the Post Anesthesia Care Unit (PACU)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Onyi Onuoha, MD, MPH principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Human Albumin (colloid), Lactated Ringer's Injection (crystalloid) and Edwards HemoSphere monitor with ClearSight-Acumen finger cuff in people with Pre-Eclampsia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Orlando, MD (917-496-7490, barbara.orlando@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with fluid responsiveness (time frame: from baseline to thirty minutes after arrival to the Post Anesthesia Care Unit (PACU)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.