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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506152-24-00
Enrollment
82
Registered
2023-09-22
Start date
2023-11-28
Completion date
Unknown
Last updated
2024-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial hypotension during deep inferior epigastric perforator (DIEP) free flap breast reconstruction

Brief summary

Total intraoperative fluid volume (from anaesthesia induction until completed skin closure)

Detailed description

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)

Interventions

DRUGPlasma-Lyte® 148 (pH 7.4) solution for infusion
DRUGNORADRENALINE (NOREPINEPHRINE) 1 mg / ml Concentrate for solution for infusion

Sponsors

Az Maria Middelares Gent, Az Maria Middelares Gent
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Total intraoperative fluid volume (from anaesthesia induction until completed skin closure)

Secondary

MeasureTime frame
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)

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026