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

• Sponsor: Szeged University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03288051
• Collaborator: Department of Oral and Maxillofacial Surgery, University of Szeged (Other), Institute of Surgical Research, University of Szeged (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 52.7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Optimal Tissue Perfusion	Other: Fluid management; Drug: Norepinephrine; Drug: Dobutamine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effects of Intraoperative, Goal-directed Crystalloid vs. Colloid Fluid Resuscitation on Microcirculation in Free Flap Reconstruction of Intraoral Tumours.
• Actual Study Start Date: Apr 28, 2014
• Actual Primary Completion Date: Feb 28, 2017
• Actual Study Completion Date: Sep 19, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Crystalloid group	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.; Drug: 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.
Active Comparator: Colloid group	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.; Drug: 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.

Outcome Measures

Primary Outcome Measures

1. Changes of Pulse pressure variation during the operation and the post-operative 24 hours [24 hours]

2. Assesment of free falp microcirculation by laser dopler flowmetry method. [24 hours]

3. Total need of Norepinephrine and Dobutamine during surgery and the post-operative 24 hours. [24 hours]

4. Changes of Cardiac Index during the operation and the post-operative 24 hours. [24 hours]

5. Mean arterial pressure during the operation and the post-operative 24 hours. [24 hours]

Secondary Outcome Measures

1. Length of Intensive Care Unit stay [24 hours]

2. Number of surgical or non-surgical complications. [24 hours]

3. Length of Hospital stay [10 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anaesthesiology and Intensive Therapy	Szeged	Csongrád	Hungary	6725

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Zsolt Molnár, MD, PhD, DEAA, head of department, Szeged University
• ClinicalTrials.gov Identifier: NCT03288051
• Other Study ID Numbers: Free Flap Microcirculation
• First Posted: Sep 19, 2017
• Last Update Posted: May 15, 2019
• Last Verified: May 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dobutamine; Norepinephrine

Study Results

No Results Posted as of May 15, 2019