Effects of Intraoperative, Goal-directed Crystalloid vs. Colloid Fluid Resuscitation on Free Flaps

University of Szeged (SZTE)

Status: Completed

Conditions: Optimal Tissue Perfusion

Treatments: Other: Fluid management; Drug: Dobutamine; Drug: Norepinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT03288051

Free Flap Microcirculation

Details and patient eligibility

About

Maintaining satisfactory tissue perfusion is an essential of success during reconstructive free flap surgery following malign oral cavity tumours. Intra- and postoperative goal-directed fluid therapy is an appropriate tool for that. Continuous cardiac output monitoring based fluid loading (complemented with vasopressor and/or inotropes if necessary) might be superior to conventional, central venous and arterial pressure monitoring in terms of morbidity, complications, optimal fluid balance and days spent in hospital. However, there is no data describing the effects of goal-directed fluid therapy (crystalloid or colloid) on microcirculation of free flaps implanted in the oral cavity during the post-operative period. The aim of this study is to observe the effects of continuous macrohaemodynamic monitoring based, goal-directed fluid therapy on microcirculation of forearm flaps during the perioperative period.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 18
• Tumour location: intraoral
• Free flap type: radial forearm
• Signed informed concent form

Exclusion criteria

• Vulnerable subject as defined in International Standards Organization 14155:2011
• End stage oral cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Crystalloid group

Active Comparator group

Treatment:

Drug: Norepinephrine

Other: Fluid management

Drug: Dobutamine

Colloid group

Active Comparator group

Treatment:

Drug: Norepinephrine

Other: Fluid management

Drug: Dobutamine