Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction
Recruiting
Phase 4
Interventional Study
Hypotension During Surgery
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 82 (estimated)
- Sponsor
- Algemeen Ziekenhuis Maria Middelares · Other
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About This Trial
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 administration. This study aims to determine whether the use of a measurement of preload dependency (Pulse Pressure Variation = PPV), can guide fluid therapy and if it decreases the risk of flap oedema. For…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* present atrial fibrillation (AF)
* heart failure New York Heart Association (NYHA) classific…
Contacts