Clinical trial NCT03288051: Effects of Intraoperative, Goal-directed Crystalloid vs. Colloid Fluid Resuscitation on Free Flaps
Official title: Effects of Intraoperative, Goal-directed Crystalloid vs. Colloid Fluid Resuscitation on Microcirculation in Free Flap Reconstruction of Intraoral Tumours.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Optimal Tissue Perfusion
Lead sponsor: Szeged University
Sponsor class: OTHER
Collaborators: name: Department of Oral and Maxillofacial Surgery, University of Szeged
name: Institute of Surgical Research, University of Szeged
First posted: 2017-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes of Pulse pressure variation during the operation and the post-operative 24 hours
timeFrame: 24 hours
measure: Assesment of free falp microcirculation by laser dopler flowmetry method.
timeFrame: 24 hours
measure: Total need of Norepinephrine and Dobutamine during surgery and the post-operative 24 hours.
timeFrame: 24 hours
measure: Changes of Cardiac Index during the operation and the post-operative 24 hours.
timeFrame: 24 hours
measure: Mean arterial pressure during the operation and the post-operative 24 hours.
timeFrame: 24 hours
Secondary outcomes:
measure: Length of Intensive Care Unit stay
timeFrame: 24 hours
measure: Number of surgical or non-surgical complications.
timeFrame: 24 hours
measure: Length of Hospital stay
timeFrame: 10 days
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: Department of Anaesthesiology and Intensive Therapy
state: Csongrád
Study officials:
References:
citation: Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191. doi: 10.1186/cc12885.
citation: Holzle F, Rau A, Loeffelbein DJ, Mucke T, Kesting MR, Wolff KD. Results of monitoring fasciocutaneous, myocutaneous, osteocutaneous and perforator flaps: 4-year experience with 166 cases. Int J Oral Maxillofac Surg. 2010 Jan;39(1):21-8. doi: 10.1016/j.ijom.2009.10.012. Epub 2009 Nov 26.
citation: Cecconi M, Hofer C, Teboul JL, Pettila V, Wilkman E, Molnar Z, Della Rocca G, Aldecoa C, Artigas A, Jog S, Sander M, Spies C, Lefrant JY, De Backer D; FENICE Investigators; ESICM Trial Group. Fluid challenges in intensive care: the FENICE study: A global inception cohort study. Intensive Care Med. 2015 Sep;41(9):1529-37. doi: 10.1007/s00134-015-3850-x. Epub 2015 Jul 11.
citation: Laszlo I, Janovszky A, Lovas A, Vargan V, Oveges N, Tanczos T, Mikor A, Trasy D, Loderer Z, Piffko J, Szabo A, Molnar Z. Effects of goal-directed crystalloid vs. colloid fluid therapy on microcirculation during free flap surgery: A randomised clinical trial. Eur J Anaesthesiol. 2019 Aug;36(8):592-604. doi: 10.1097/EJA.0000000000001024.