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

Optimal Tissue Perfusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03288051
• Other study ID #: Free Flap Microcirculation
• Status: Completed
• Phase: N/A
• Start date: April 28, 2014
• Est. completion date: September 19, 2018

Study information

• Verified date: May 2019
• Source: Szeged University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 19, 2018
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Optimal Tissue Perfusion

Intervention

Other:
• Fluid management
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.

Drug:
• Norepinephrine
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
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.

Locations

Country	Name	City	State
Hungary	Department of Anaesthesiology and Intensive Therapy	Szeged	Csongrád

Sponsors (3)

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

Country where clinical trial is conducted

Hungary, 

References & Publications (3)

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. Erratum in: Intensive Care Med. 2015 Sep;41(9):1737-8. multiple investigator names added. — View Citation

Hölzle F, Rau A, Loeffelbein DJ, Mücke 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Pulse pressure variation during the operation and the post-operative 24 hours		24 hours
Primary	Assesment of free falp microcirculation by laser dopler flowmetry method.		24 hours
Primary	Total need of Norepinephrine and Dobutamine during surgery and the post-operative 24 hours.		24 hours
Primary	Changes of Cardiac Index during the operation and the post-operative 24 hours.		24 hours
Primary	Mean arterial pressure during the operation and the post-operative 24 hours.		24 hours
Secondary	Length of Intensive Care Unit stay		24 hours
Secondary	Number of surgical or non-surgical complications.		24 hours
Secondary	Length of Hospital stay		10 days