NCT06107335Not yet recruitingPhase 4
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
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
Source: ClinicalTrials.gov · Last updated 6 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- First submitted
- 24 Oct 2023
- Start date
- 1 Jul 2025
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- The University of Texas Health Science Center, Houston
- NCT number
- NCT06107335
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 62
- From 1 Jul 2025 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Contraindications to the use of neuraxial anesthesia (coagulopathy, infection at the insertion site, intracranial mass etc.)
- 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.
Other
- Patient declines to participate in the study
- Labor
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.