Completed

NCT Number: NCT03288051

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

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.

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Key information

Conditions

Optimal Tissue Perfusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology and Intensive Therapy

Szeged, Csongrád megye, 6725, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluid Management

Other

Primary fluid admission: 1 mL/bodyweight kg/ hour crystalloid. If Pulse pressure variation is lower than 10%; 250 mL/15 min of colloid or crystalloid is administered depending on randomization.

norepinephrine

Drug

Norepinephrine is administered if Mean arterial pressure drops below 65 mmHg. Mean arterial pressure must be maintained above 65 mmHg. Norepinephrine is titrated accordingly.

Dobutamine

Drug

Dobutamine is administered if Cardiac index drops below 2.5 L/min/m2. Cardiac index must be maintained above 2.5 L/min/m2. Dobutamine is titrated accordingly.

Primary outcomes

Changes of Pulse pressure variation during the operation and the post-operative 24 hours

Time frame: 24 hours
Assesment of free falp microcirculation by laser dopler flowmetry method.

Time frame: 24 hours
Total need of Norepinephrine and Dobutamine during surgery and the post-operative 24 hours.

Time frame: 24 hours
Changes of Cardiac Index during the operation and the post-operative 24 hours.

Time frame: 24 hours
Mean arterial pressure during the operation and the post-operative 24 hours.

Time frame: 24 hours

Secondary outcomes

Length of Intensive Care Unit stay

Time frame: 24 hours
Number of surgical or non-surgical complications.

Time frame: 24 hours
Length of Hospital stay

Time frame: 10 days

Sponsors and collaborators

Lead sponsor

Szeged University

Other

Collaborators

Department of Oral and Maxillofacial Surgery, University of Szeged
Institute of Surgical Research, University of Szeged

Registry information

Official study title

Effects of Intraoperative, Goal-directed Crystalloid vs. Colloid Fluid Resuscitation on Microcirculation in Free Flap Reconstruction of Intraoral Tumours.

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2018
First posted: Sep 19, 2017
Registry last updated: May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.