CTIS2023-506152-24-00
Recruiting
Phase 1
Goal-directed Fluid Therapy during deep inferior epigastric perforator (DIEP) free flap breast reconstruction – a randomized controlled trial
Az Maria Middelares Gent0 sites82 target enrollmentJune 29, 2023
ConditionsArterial hypotension during deep inferior epigastric perforator (DIEP) free flap breast reconstructionMedDRA version: 21.1Level: LLTClassification code: 10066331Term: Arterial hypotension Class: 10047065MedDRA version: 23.0Level: LLTClassification code: 10050632Term: Postoperative hypotension Class: 10022117MedDRA version: 21.0Level: LLTClassification code: 10056679Term: Intraoperative hypotension Class: 10022117Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Arterial hypotension during deep inferior epigastric perforator (DIEP) free flap breast reconstruction
- Sponsor
- Az Maria Middelares Gent
- Enrollment
- 82
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
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
Exclusion Criteria
- •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, Patients who are pregnant or breastfeeding, Inability of the patient to understand Dutch sufficiently
Outcomes
Primary Outcomes
Not specified
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