Status:
RECRUITING
Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction
Lead Sponsor:
Algemeen Ziekenhuis Maria Middelares
Conditions:
Hypotension During Surgery
Eligibility:
FEMALE
18-70 years
Phase:
PHASE4
Brief Summary
Adequate free flap perfusion during Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction surgery requires maintaining blood pressure above 100 mmHg and avoiding excessive fluid admini...
Detailed Description
For adequate free flap perfusion during Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction surgery, blood pressure must remain sufficiently high. General anaesthesia often induces s...
Eligibility Criteria
Inclusion
- Female adult patients, between 18 and 70 years of age
- Patients scheduled for DIEP free flap breast reconstruction
- Signed written informed consent form (ICF)
Exclusion
- present atrial fibrillation (AF)
- heart failure New York Heart Association (NYHA) classification 2 or higher
- chronic kidney disease (CKD) stage 3B or higher
- American Society of Anesthesiologists (ASA) classification III or higher
- known allergy to study specific medication
- participation in another clinical trial
- Inability of the patient to understand Dutch sufficiently
- Patients who are pregnant or breastfeeding
Key Trial Info
Start Date :
November 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT06080178
Start Date
November 23 2023
End Date
October 1 2026
Last Update
January 28 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
AZ Maria Middelares
Ghent, East Flanders, Belgium, 9000