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

Not Applicable

Completed

• Conditions: Optimal Tissue Perfusion
• Interventions: Other: Fluid management; Drug: Norepinephrine; Drug: Dobutamine

• Registration Number: NCT03288051
• Lead Sponsor: Szeged University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-28
• Primary Completion: 2017-02-28
• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-09-15
• Study First Posted: 2017-09-19
• Study Completion: 2018-09-19
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colloid group	Fluid management	-
Crystalloid group	Fluid management	-
Crystalloid group	Norepinephrine	-
Crystalloid group	Dobutamine	-
Colloid group	Norepinephrine	-
Colloid group	Dobutamine	-

Primary Outcome Measures

Name	Time	Method
Total need of Norepinephrine and Dobutamine during surgery and the post-operative 24 hours.	24 hours
Mean arterial pressure during the operation and the post-operative 24 hours.	24 hours
Assesment of free falp microcirculation by laser dopler flowmetry method.	24 hours
Changes of Cardiac Index during the operation and the post-operative 24 hours.	24 hours
Changes of Pulse pressure variation during the operation and the post-operative 24 hours	24 hours

Secondary Outcome Measures

Name	Time	Method
Length of Intensive Care Unit stay	24 hours
Number of surgical or non-surgical complications.	24 hours
Length of Hospital stay	10 days

Trial Locations

Locations (1)

Department of Anaesthesiology and Intensive Therapy; 🇭🇺 Szeged, Csongrád, Hungary