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

NCT03288051 | Completed

• 1 other identifier: Free Flap Microcirculation
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Optimal Tissue Perfusion

Outcome Measures

Primary Outcomes (5)

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

  24 hours

• Assesment of free falp microcirculation by laser dopler flowmetry method.

  24 hours

• Total need of Norepinephrine and Dobutamine during surgery and the post-operative 24 hours.

  24 hours

• Changes of Cardiac Index during the operation and the post-operative 24 hours.

  24 hours

• Mean arterial pressure during the operation and the post-operative 24 hours.

  24 hours

Secondary Outcomes (3)

• Length of Intensive Care Unit stay

  24 hours

• Number of surgical or non-surgical complications.

  24 hours

• Length of Hospital stay

  10 days

Study Arms (2)

Crystalloid group

ACTIVE COMPARATOR

Other: Fluid management; Drug: Norepinephrine; Drug: Dobutamine

Colloid group

ACTIVE COMPARATOR

Other: Fluid management; Drug: Norepinephrine; Drug: Dobutamine

Interventions

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.

Colloid group; Crystalloid group

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.

Colloid group; Crystalloid group

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.

Colloid group; Crystalloid group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18
• Tumour location: intraoral
• Free flap type: radial forearm
• Signed informed concent form

You may not qualify if:

• Vulnerable subject as defined in International Standards Organization 14155:2011
• End stage oral cancer

Sponsors & Collaborators

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

Study Sites (1)

Department of Anaesthesiology and Intensive Therapy

Szeged, Csongrád megye, 6725, Hungary

Location

Related Publications (4)

• 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.

  PMID: 24010849 BACKGROUND

• 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.

  PMID: 19944567 BACKGROUND

• 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.

  PMID: 26162676 BACKGROUND

• 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.

  PMID: 31157652 DERIVED

MeSH Terms

Interventions

Norepinephrine; Dobutamine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of department

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 19, 2017
• Study Start: April 28, 2014
• Primary Completion: February 28, 2017
• Study Completion: September 19, 2018
• Last Updated: May 15, 2019

Record last verified: 2019-05

Locations

HU (1)