Perioperative Fluid ManagementNCT04728178

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

A study testing Crystalloid solution and Colloid solution in people with Perioperative Fluid Management, run by Istanbul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Perioperative Fluid Management
What is being tested?: Crystalloid solution and Colloid solution
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Oct 2017to 1 May 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Istanbul University, Department of Anesthesiology
Istanbul, Fatih, 34093

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Perioperative Standard Fluid Management and Goal-Directed Fluid Management in Patients Undergoing Head and Neck Surgery: A Prospective Randomized Clinical Trial

Read the detailed description

Following the ethics committee approval and patients consent, the study was completed with a total of ASA I-III, 60 patients over the age of 18 who will undergo head and neck surgery.After randomization, patients underwent arterial cannulation. The arterial cannulas of the study group patients were integrated into the hemodynamic monitoring system with a special transducer, and their fluid management was planned to achieve a target value of 13% or less through SVV monitoring. 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 in both groups. 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. The patients in the control group 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.

Conditions: Perioperative Fluid Management
Being tested: Crystalloid solution, Colloid solution
Keywords: fluid therapy, prolonged oxygen demand, perioperative fluid balance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Crystalloid solutionOther
Crystalloid solution is a true solution and is able to pass through a semipermeable membrane.
Colloid solutionOther
Colloid solution is a heterogeneous mixture whose particle size is intermediate between those of a solution and a suspension.

Study groups in NCT04728178
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Crystalloid solution; Other: Colloid solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Intraoperative fluid balance
the total and additional amount of crystalloid and colloid fluid fluid given during the surgery
Measured: during surgery

Secondary outcomes (9)

Prolonged IMV demand
The need for artificial respiration for 8 hours or more in patients admitted to the postoperative intensive care unit.
Measured: during 8 hours after surgery
Prolonged oxygen demand
The need for additional oxygen application with a mask for 8 hours or more in patients who are taken into postoperative service follow-up.
Measured: during 8 hours after surgery
Heart rate
EKG
Measured: during surgery
Blood Pressure
Arterial line and pressure transducer
Measured: during surgery
hospitalisation time
calendar
Measured: postoperative period (up to 6 weeks)
lenght of stay in ICU
calendar
Measured: postoperative period (up to 6 weeks)
hypoxia
blood gas machine
Measured: during surgery
hypercarbia
blood gas machine
Measured: during surgery
pulmonary infection
sputum culture test
Measured: postoperative period (up to 6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20171 May 2019

First posted28 Jan 2021
Study start1 Oct 2017
Primary completion1 Jan 2019
Study completion1 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Perioperative Fluid ManagementStudies of the same condition, open and under way.
More trials run by Istanbul UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04728178
Sponsor's protocol ID: 2017/1122
Status last verified: Jan 2021
First submitted: 20 Jan 2021
Last updated: 28 Jan 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 23965199
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.
PubMed 26665136

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study Of Ultrasound Windows For Measuring Inferior Vena Cava Changes Before Cardiac Surgery
Perioperative Fluid Management, Hemodynamic Monitoring
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Effect of VExUS Ultrasound Protocol (Venous Excess Ultrasound) on Perioperative Fluid Management, on the Incidence of Postoperative Pulmonary Complications and Postoperative Acute Kidney Injury in Patients Undergoing Thoracic Surgery
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All Perioperative Fluid Management trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Perioperative Standard Fluid Management and Goal-Directed Fluid Management in Patients Undergoing Head and Neck Surgery: A Prospective Randomized Clinical Trial
ClinicalTrials.gov ID: NCT04728178
Acronym / sponsor ID: 2017/1122
Conditions: Perioperative Fluid Management
Keywords: fluid therapy, prolonged oxygen demand, perioperative fluid balance
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Istanbul UniversityUniversity, hospital or other
Study start: 1 Oct 2017 (actual)
Primary completion: 1 Jan 2019 (actual)
Study completion: 1 May 2019 (actual)
First posted: 28 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
study group	Active comparator	Other: Crystalloid solution, Other: Colloid solutionIn 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.
control group	Placebo comparator	Other: Crystalloid solution, Other: Colloid solutionIn 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Crystalloid solutionCrystalloid solution is a true solution and is able to pass through a semipermeable membrane.	Other	control group, study group
Colloid solutionColloid solution is a heterogeneous mixture whose particle size is intermediate between those of a solution and a suspension.	Other	control group, study group

Primary outcome

Intraoperative fluid balance
Time frame: during surgery
the total and additional amount of crystalloid and colloid fluid fluid given during the surgery

9 secondary outcomes

Prolonged IMV demand
Time frame: during 8 hours after surgery
Prolonged oxygen demand
Time frame: during 8 hours after surgery
Heart rate
Time frame: during surgery
Blood Pressure
Time frame: during surgery
hospitalisation time
Time frame: postoperative period (up to 6 weeks)
lenght of stay in ICU
Time frame: postoperative period (up to 6 weeks)
hypoxia
Time frame: during surgery
hypercarbia
Time frame: during surgery
pulmonary infection
Time frame: postoperative period (up to 6 weeks)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
Background: PubMed 23965199Davies 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.
Background: PubMed 26665136Funk 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.

Related trials for Perioperative Fluid Management

Not yet recruiting
ASSISTED FLUID MANAGEMENT SYSTEM IN KIDENY TRANSPLANTATION
Kidney Transplant
Recruiting
Goal-Directed Temperature Management During Prolonged Abdominal Surgery
Hypothermia Following Anesthesia, Intraoperative Complications
Recruiting
Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) for Perioperative Hemodynamic Optimization in Patients Under General Anesthesia
Intraoperative Hypotension
Not yet recruitingObservational study
Study Of Ultrasound Windows For Measuring Inferior Vena Cava Changes Before Cardiac Surgery
Perioperative Fluid Management, Hemodynamic Monitoring
Recruiting
Effect of VExUS Ultrasound Protocol (Venous Excess Ultrasound) on Perioperative Fluid Management, on the Incidence of Postoperative Pulmonary Complications and Postoperative Acute Kidney Injury in Patients Undergoing Thoracic Surgery
Thoracic Surgery With One-lung Ventilation, VExUS

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Demet Altun Bingol, Assoc. Prof. principal investigator

Istanbul University

Nuray Turkut, MD principal investigator

Istanbul University

Cansu Uzuntürk, Resident principal investigator

Istanbul University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Crystalloid solution and Colloid solution in people with Perioperative Fluid Management, run by Istanbul University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraoperative fluid balance (time frame: during surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04728178, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.