Overview
Sponsor-declared trial summary
Arterial hypotension during deep inferior epigastric perforator (DIEP) free flap breast reconstruction
To investigate the effect of a goal-directed fluid management during DIEP free flap breast reconstruction on perioperative fluid administration
Key facts
- Sponsor
- Az Maria Middelares Gent
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 28 Nov 2023 → ongoing
- Decision date (initial)
- 2023-09-22
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To investigate the effect of a goal-directed fluid management during DIEP free flap breast reconstruction on perioperative fluid administration
Secondary objectives 1
- The expected fluid restriction may lead to a reduction in postoperative tissue oedema and better flap perfusion as measured by NIRS
Conditions and MedDRA coding
Arterial hypotension during deep inferior epigastric perforator (DIEP) free flap breast reconstruction
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10066331 | Arterial hypotension | 10047065 |
| 23.0 | LLT | 10050632 | Postoperative hypotension | 10022117 |
| 21.0 | LLT | 10056679 | Intraoperative hypotension | 10022117 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- 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 8
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Total intraoperative fluid volume (from anaesthesia induction until completed skin closure)
Secondary endpoints 7
- cumulative perioperative fluid volume (intraoperative fluid volume + fluid administered in the intensive care unit (ICU) or post-anaesthesia care unit (PACU))
- cumulative intraoperative norepinephrine dose (intraoperative and postoperative norepinephrine dose)
- peri- and postoperative blood lactate levels (hourly measurement during surgery, every four hours in the ICU until discharge)
- percentage of time SBP was above 100mmHg
- postoperative free flap perfusion monitored by NIRS during ICU/ PACU stay
- surgical complications (e.g. total or partial flap loss, venous flap congestion, hematoma) assessed at ICU/ PACU discharge and at hospital discharge
- ICU/PACU length of stay (LOS) (hours)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Plasma-Lyte® 148 (pH 7.4) solution for infusion
PRD332654 · Product
- Active substance
- Magnesium Chloride Hexahydrate
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 100 millilitre(s)/kilogram
- Max total dose
- 150 millilitre(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- PL 00116/0332
- MA holder
- BAXTER HEALTHCARE LTD.
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
NORADRENALINE (NOREPINEPHRINE) 1 mg / ml Concentrate for solution for infusion
PRD589255 · Product
- Active substance
- Noradrenaline Tartrate
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 288 µg/Kg microgram(s)/kilogram
- Max total dose
- 288 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01CA03 — NOREPINEPHRINE
- Marketing authorisation
- PL 14434/0017
- MA holder
- LABORATOIRE AGUETTANT
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Az Maria Middelares Gent
- Sponsor organisation
- Az Maria Middelares Gent
- Address
- Buitenring-Sint-Denijs 30
- City
- Gent
- Postcode
- 9000
- Country
- Belgium
Scientific contact point
- Organisation
- Az Maria Middelares Gent
- Contact name
- Ella Hermie
Public contact point
- Organisation
- Az Maria Middelares Gent
- Contact name
- Steffi Ryckaert
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 82 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2023-11-28 | 2024-02-12 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-29 | Belgium | Acceptable with conditions 2023-09-22
|
2023-09-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-02 | Belgium | Acceptable 2023-11-18
|
2023-11-23 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-01-04 | Belgium | Acceptable 2023-11-18
|
2024-01-04 |