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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06107335
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Pre-Eclampsia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Human Albumin (colloid) — DRUG
    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 cuff — DEVICE
    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 Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Dec 2024
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Fluid restriction using 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).
  • Experimental: Fluid replacement using colloid as guided by stroke volume variation (SVV)
    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.

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Barbara Orlando, MD
[email protected]
917-496-7490

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By research site
The University of Texas Health Science Center at Houston· Houston, TX

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