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NCT06107335 · ClinicalTrials.gov registry record · Phase 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
A Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.
- Not yet
- Registry status
- Phase 4
- Development phase
- 62
- Enrollment target
NCT06107335: Clinical Trial Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.
NCT06107335 is a Phase 4 study that has not yet begun recruiting, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 62 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06107335, a Phase 4 study, has not yet begun recruiting, sponsored by The University of Texas Health Science Center, Houston.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 62 participants
- Enrollment target
Study 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.
Primary Outcome
"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.
Interventions
- DRUG Human Albumin (colloid)
- DRUG Lactated Ringer's Injection (crystalloid)
- DEVICE Edwards HemoSphere monitor with ClearSight-Acumen finger cuff
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2025-07-01 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 4 |
What is known before NCT06107335 opens enrollment
NCT06107335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which Human Albumin (colloid) is the first listed.
NCT06107335 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06107335 about?
NCT06107335 is a clinical study titled "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". 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) ...
What is the current status of trial NCT06107335?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 62 participants. The study started on 2025-07-01. Estimated completion is 2026-12-01.
What interventions are being tested in trial NCT06107335?
The interventions under investigation include: Human Albumin (colloid) (DRUG), Lactated Ringer's Injection (crystalloid) (DRUG), Edwards HemoSphere monitor with ClearSight-Acumen finger cuff (DEVICE).
Who is sponsoring clinical trial NCT06107335?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06107335's enrollment target sits among peer trials
62 1110th of 2000 higher than 882 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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