Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from baseline to thirty minutes after arrival to the Post Anesthesia Care Unit (PACU) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with fluid responsiveness stability | from baseline to thirty minutes after arrival to the Post Anesthesia Care Unit (PACU) | |
| Maternal blood pressure (diastolic) | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barbara Orlando, MD | Contact | 917-496-7490 | barbara.orlando@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Onyi Onuoha, MD, MPH | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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. |
|
| Maternal blood pressure (systolic) | 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 | from start of operation to thirty minutes after arrival to the Post Anesthesia Care Unit (PACU) |
| Number of adverse events | from start of operation to discharge from the Post Anesthesia Care Unit (PACU) |
| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000075462 | Serum Albumin, Human |
| D003102 | Colloids |
| D000418 | Albumins |
| D000077325 | Ringer's Lactate |
| D000077324 | Crystalloid Solutions |
| ID | Term |
|---|---|
| D012709 | Serum Albumin |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001798 | Blood Proteins |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
Not provided
Not provided