Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction

PHASE4RecruitingINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

November 23, 2023

Primary Completion Date

October 1, 2026

Study Completion Date

October 1, 2026

Conditions
Hypotension During Surgery
Interventions
DRUG

Plasma-lyte (static group)

Plasmalyte will be administered intravenously: (1) as a maintenance infusion 1ml/kg/h (from anaesthesia induction until ICU/PACU discharge); (2) as a fluid bolus until 5ml/kg/h crystalloid (without maintenance infusion) is reached or until SBP is above 100mmHg

DRUG

Norepinephrine (static group)

When during surgery SBP is below 100mmHg, if the 5ml/kg/h crystalloid limit is already reached, start or increase norepinephrine infusion until SBP is above 100mmHg (with a maximum dose of 0.2mcg/kg/min).

DRUG

Plasma-lyte (dynamic group)

"Plasmalyte will be administered intravenously:~(1) as a maintenance infusion 1 ml/kg/h (from anaesthesia induction until ICU/PACU discharge); (2) as a fluid bolus until PPV is below or equal to 12% or SBP is above 100mmHg."

DRUG

Norepinephrine (dynamic group)

"When during surgery SBP is below 100mmHg and PPV is below or equal to 12%: start or increase norepinephrine infusion until SBP is above 100mmHg (with a maximum dose of 0.2mcg/kg/min).~When SBP is above 120mmHg: decrease the norepinephrine infusion rate until SBP is below 120mmHg."

Trial Locations (1)

9000

RECRUITING

AZ Maria Middelares, Ghent

All Listed Sponsors
lead

Algemeen Ziekenhuis Maria Middelares

OTHER