Goal-directed Fluid Therapy during deep inferior epigastric perforator (DIEP) free flap breast reconstruction – a randomized controlled trial

Phase 1

Recruiting

Conditions: Arterial hypotension during deep inferior epigastric perforator (DIEP) free flap breast reconstruction
MedDRA version: 21.1Level: LLTClassification code: 10066331Term: Arterial hypotension Class: 10047065
MedDRA version: 23.0Level: LLTClassification code: 10050632Term: Postoperative hypotension Class: 10022117
MedDRA version: 21.0Level: LLTClassification code: 10056679Term: Intraoperative hypotension Class: 10022117
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: CTIS2023-506152-24-00

Lead Sponsor: Az Maria Middelares Gent

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 82

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of a goal-directed fluid management during DIEP free flap breast reconstruction on perioperative fluid administration;Secondary Objective: The expected fluid restriction may lead to a reduction in postoperative tissue oedema and better flap perfusion as measured by NIRS;Primary end point(s): Total intraoperative fluid volume (from anaesthesia induction until completed skin closure)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):cumulative perioperative fluid volume (intraoperative fluid volume + fluid administered in the intensive care unit (ICU) or post-anaesthesia care unit (PACU));Secondary end point(s):cumulative intraoperative norepinephrine dose (intraoperative and postoperative norepinephrine dose);Secondary end point(s):peri- and postoperative blood lactate levels (hourly measurement during surgery, every four hours in the ICU until discharge);Secondary end point(s):percentage of time SBP was above 100mmHg;Secondary end point(s):postoperative free flap perfusion monitored by NIRS during ICU/ PACU stay;Secondary end point(s):surgical complications (e.g. total or partial flap loss, venous flap congestion, hematoma) assessed at ICU/ PACU discharge and at hospital discharge;Secondary end point(s):ICU/PACU length of stay (LOS) (hours)