Comparison of Perioperative Standard Fluid Management and Goal-Directed Fluid Management

NCT04728178 | Completed

• 1 other identifier: 2017/1122
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the goal-directed fluid therapy based on the data obtained from the hemodynamic monitoring system, which provides continuous CO, SV and SVV measurements through arterial pressure wave with standard fluid therapy in perioperative fluid management of patients undergoing head and neck surgery.

Conditions

Perioperative Fluid Management

Keywords

fluid therapy; prolonged oxygen demand; perioperative fluid balance

Outcome Measures

Primary Outcomes (1)

• Intraoperative fluid balance

  the total and additional amount of crystalloid and colloid fluid fluid given during the surgery

  during surgery

Secondary Outcomes (9)

• Prolonged IMV demand

  during 8 hours after surgery

• Prolonged oxygen demand

  during 8 hours after surgery

• Heart rate

  during surgery

• Blood Pressure

  during surgery

• hospitalisation time

  postoperative period (up to 6 weeks)

Study Arms (2)

study group

ACTIVE COMPARATOR

In the control group, fluid management was set as MAP (Mean arterial pressure) 65 mmHg and above and diuresis 0.5ml/kg/hour and above. Crystalloid infusion at 7ml/kg/hour was started. When SVV value increased to 13% and over in the study group, 250 ml of crystalloid was given in the first stage, and if it continued to be 13% and over, 250 ml of colloid bolus was given. Vasoconstrictor agent was used when SVV was below 13% and MAP was below 65 mmHg.

Other: Crystalloid solution; Other: Colloid solution

control group

PLACEBO COMPARATOR

In the control group, fluid management was set as MAP (Mean arterial pressure) 65 mmHg and above and diuresis 0.5ml/kg/hour and above. Crystalloid infusion at 7ml/kg/hour was started. They were given 250 ml of crystalloid in the first stage if the MAP was below 65 mmHg, and 250 ml of colloid bolus if the hypotensive episode continued. If hypotension persisted despite these fluid boluses, a vasoconstrictor agent was used. In addition, when the diuresis of the patients was detected at 0.5mg/kg/hr or less, 250 ml of colloid bolus was administered.

Other: Crystalloid solution; Other: Colloid solution

Interventions

Crystalloid solution OTHER

Crystalloid solution is a true solution and is able to pass through a semipermeable membrane.

control group; study group

Colloid solution OTHER

Colloid solution is a heterogeneous mixture whose particle size is intermediate between those of a solution and a suspension.

control group; study group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteering to participate in the study
• ASA classification 1, 2 or 3
• The patients who will undergo head and neck surgery

You may not qualify if:

• Being under the age of 18 or over the age of 80
• Presence of serious cardiac, renal and liver pathology ( ejection fraction\< %35 and/or glomerular filtration rate\< 30ml/kg/min, kreatinin\>2,5mg/dl and/or abnormal liver function test)
• The patients who have heart rhythm problems such as atrial fibrillation, sinus tachycardia, ventricular extrasystoles
• The patients who have a peripheral arterial disease
• Being a morbid obese ( BMI\>40 kg/m2)
• the patients who may have considered difficult airway

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Department of Anesthesiology

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (2)

• Davies SJ, Minhas S, Wilson RJ, Yates D, Howell SJ. Comparison of stroke volume and fluid responsiveness measurements in commonly used technologies for goal-directed therapy. J Clin Anesth. 2013 Sep;25(6):466-74. doi: 10.1016/j.jclinane.2013.04.010. Epub 2013 Aug 17.

  PMID: 23965199 BACKGROUND

• Funk D, Bohn J, Mutch W, Hayakawa T, Buchel EW. Goal-directed fluid therapy for microvascular free flap reconstruction following mastectomy: A pilot study. Plast Surg (Oakv). 2015 Winter;23(4):231-4. doi: 10.4172/plastic-surgery.1000937.

  PMID: 26665136 BACKGROUND

MeSH Terms

Interventions

Crystalloid Solutions

Intervention Hierarchy (Ancestors)

Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Demet Altun Bingol, Assoc. Prof.

  Istanbul University

  PRINCIPAL INVESTIGATOR

• Nuray Turkut, MD

  Istanbul University

  PRINCIPAL INVESTIGATOR

• Cansu Uzuntürk, Resident

  Istanbul University

  PRINCIPAL INVESTIGATOR

• Emre Çamcı, Prof.

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending anesthesiologist

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 28, 2021
• Study Start: October 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: May 1, 2019
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

TU (1)