Clinical trial NCT06107335: 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Pre-Eclampsia
Keywords: Pre-Eclampsia
Albumin
Hemodynamic
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 cesarean delivery (CD), improves hemodynamic stability in preeclamptic patients with severe features compared to routine care, under neuraxial anesthesia.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of participants with fluid responsiveness
timeFrame: from baseline to thirty minutes after arrival to the Post Anesthesia Care Unit (PACU)
Secondary outcomes:
measure: Number of participants with fluid responsiveness stability
timeFrame: from baseline to thirty minutes after arrival to the Post Anesthesia Care Unit (PACU)
measure: Maternal blood pressure (diastolic)
timeFrame: 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
measure: Maternal blood pressure (systolic)
timeFrame: 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
measure: Total amount in milligrams of rescue vasopressor drug given
timeFrame: from start of operation to thirty minutes after arrival to the Post Anesthesia Care Unit (PACU)
measure: Number of adverse events
timeFrame: from start of operation to discharge from the Post Anesthesia Care Unit (PACU)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Onyi Onuoha, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: