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Trial registered on ANZCTR


Registration number
ACTRN12618000537257
Ethics application status
Approved
Date submitted
4/09/2017
Date registered
11/04/2018
Date last updated
14/03/2019
Date data sharing statement initially provided
14/03/2019
Date results information initially provided
14/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
How can fluid therapy be better regulated in lung operations?
Scientific title
Influence Of Stroke Volume Variation On Fluid Treatment And Postoperative Complications In Thoracic Surgery

Secondary ID [1] 292803 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fluid management during lobectomy 304617 0
Condition category
Condition code
Anaesthesiology 303936 303936 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1 (Stroke volume variation (SVV) group): The FloTrac Device (Vigileo TM Edwards Lifesciences, LLC, Irvine, CA, USA) was connected to the arterial line. The SVV measurements were taken into consideration, when tidal volume was 8 mL/kg and the thorax was closed (SVV variables were collected from intubation to skin incision and from the closure of the thorax until the end of surgery). All patients were treated with 500 mL crystalloid fluid loading intravenous infusion at the first hour. Maintenance fluid therapy was given in the intravenous boluses of 2 mL/kg, if the SVV value was greater than or equal to 13%. After the first 1000 cc crystalloid intravenous infusion treatment was added to the colloid.
Intervention code [1] 299431 0
Treatment: Other
Comparator / control treatment
Group 2 (central venous pressure (CVP) group): All patients were treated with 500 mL intravenous crystalloid fluid loading at the first hour. Fluid therapy was applied as CVP between 5 and 10 mmHg, mean arterial blood pressure (MAP) above 65 mmHg, heart rate (HR) between 60 and 100 bpm, and urine output above 0.5 mL/kg/h. Postoperative fluid was given to all patients in two groups at 1000 mL/m2/24h intravenous infusion in first postoperative day. Additional intravenous fluid infusion was given to some patients to keep urine output of > 0.5 mL/kg/h. Colloidal solutions (hydroxyethyl starch, gelofusine and albumin) were not used in postoperative period.
Control group
Active

Outcomes
Primary outcome [1] 303282 0
The primary endpoint was included the amounts of intraoperative fluid administration between the SVV group and CVP group during one-lung ventilation and lobectomy. The amount of intraoperative fluid administration was recorded in patients charts.
Timepoint [1] 303282 0
intraoperative period.
Secondary outcome [1] 338512 0
The secondary endpoint was comparisons of the postoperative complications between the SVV and CVP groups.
Postoperative complications were recorded in hospital medical records. They were defined as follows:
Respiratory complications: Pneumonia (chest x-ray,temperature >38°C; signs of infection on sputum microbiology; purulent secretion differing from preoperative status), pleural effusion (chest x-ray), atelectasis (chest x-ray), respiratory failure (hypoxemia, pulmonary edema, acute respiratory distress syndrome, re-intubation, requires mechanic ventilation) (oxygen saturations <90% on room air on the pulse oximeter, arterial blood gas (PaO2/FiO2), chest x-ray), air leak up five days, increased secretions (defined by nasotracheal suctioning or fiberoptic bronchoscopy in patients who developed postoperative atelectasis, pneumonia, or hypoxemia), and bronchopleural fistula (chest computed tomography),
Cardiac complications: Heart failure, arrhythmias (that require treatment), myocardial infarction,
Renal dysfunction: 0.3 mg/dL increase in creatinine levels compared to baseline values or need for renal replacement treatment or dialysis
Others: Stroke (cerebral hemorrhage, infarct), ileus, mesenteric ischemia, gastrointestinal bleeding, sepsis, multiple organ failure, re-operation for any reason.
Timepoint [1] 338512 0
postoperative first 30 days.

Eligibility
Key inclusion criteria
Patients undergoing lobectomy
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients undergoing surgical procedures other than lobectomy
those with severe valvular disease and arrhythmia
respiratory function test results below 50%
severe organ failure (kidney, liver, and heart failure)
patients without epidural catheter
pediatric cases

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
106 patients were included in the study. But 18 patients had lost data. For this reason, these patients were excluded from the study. To evaluate the impact of SVV on fluid therapy, a study sample size of 35 patients in each group was calculated (G*Power software, two-sided tests; type I error: 0.05, and power: 95%). Statistical analysis was performed using SPSS version 21.0 software (SPSS Inc., Chicago, IL, USA). The Kolmogorov-Smirnov test was performed to analyze normality of the distributed data. Descriptive data were expressed as mean ± standard deviation (SD), median (range), percentage (%). The chi-square and Fisher’s exact tests were used to compare categorical variables between the groups, while independent sample t-test and Mann-Whitney U test were used to analyze quantitative variables. A p value of less than 0.05 was considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9178 0
Turkey
State/province [1] 9178 0

Funding & Sponsors
Funding source category [1] 297435 0
Self funded/Unfunded
Name [1] 297435 0
Cengiz Sahutoglu
Address [1] 297435 0
Ege Universitesi Tip Fakultesi, Anesteziyoloji ve Reanimasyon Anabilim Dali, 35100, Bornova/Izmir
Country [1] 297435 0
Turkey
Primary sponsor type
Individual
Name
Cengiz Sahutoglu
Address
Ege Universitesi Tip Fakultesi, Anesteziyoloji ve Reanimasyon Anabilim Dali, 35100, Bornova/Izmir
Country
Turkey
Secondary sponsor category [1] 296431 0
Individual
Name [1] 296431 0
Seden Kocabas
Address [1] 296431 0
Ege Universitesi Tip Fakultesi, Anesteziyoloji ve Reanimasyon Anabilim Dali, 35100, Bornova/Izmir
Country [1] 296431 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298544 0
Ege University School of Medicine Clinical Research Ethical Committee
Ethics committee address [1] 298544 0
Ege Üniversitesi Tip Fakültesi Klinik Arastirmalar Etik Kurulu
Ege Üniversitesi Tip Fakültesi Dekanlik Binasi 2. kat
Bornova, IZMIR 35100

Ethics committee country [1] 298544 0
Turkey
Date submitted for ethics approval [1] 298544 0
01/10/2015
Approval date [1] 298544 0
28/03/2016
Ethics approval number [1] 298544 0
16-3.1/3

Summary
Brief summary
Fluid management usually relies on increasing preload to augment cardiac output in critically ill patients. However, recent studies have failed to demonstrate the anticipated effect in approximately 50% of the patients.This has resulted in a need for developing an accurate and reliably technique to guide the fluid management. Current preload variables such as central venous pressure (CVP) and pulmonary capillary wedge pressure (PCWP) are not reliable variables to manage fluid resuscitation. On the other hand, volumetric preload variables assessed with transpulmonary thermodilution may be superior in reflecting the left ventricular preload; however, these variables do not allow the evaluation of the fluid responsiveness. As a less invasive hemodynamic monitoring system based on arterial pulse contour analysis, stroke volume variation (SVV) allows continuous monitorization of the fluid status, and several studies have suggested that CVP can be reliably replaced by SVV in the management of fluid therapy. In the present study, therefore, we aim to evaluate whether SVV can guide fluid therapy in thoracic surgery and reduce complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77406 0
Dr Cengiz Sahutoglu
Address 77406 0
Ege Universitesi Tip Fakultesi, Anesteziyoloji ve Reanimasyon Anabilim Dali, 35100, Bornova/Izmir
Country 77406 0
Turkey
Phone 77406 0
+902323902143
Fax 77406 0
Email 77406 0
cengiz.sahutoglu@ege.edu.tr
Contact person for public queries
Name 77407 0
Dr Cengiz Sahutoglu
Address 77407 0
Ege Universitesi Tip Fakultesi, Anesteziyoloji ve Reanimasyon Anabilim Dali, 35100, Bornova/Izmir
Country 77407 0
Turkey
Phone 77407 0
+902323902143
Fax 77407 0
Email 77407 0
cengiz.sahutoglu@ege.edu.tr
Contact person for scientific queries
Name 77408 0
Prof Seden Kocabas
Address 77408 0
Ege Universitesi Tip Fakultesi, Anesteziyoloji ve Reanimasyon Anabilim Dali, 35100, Bornova/Izmir
Country 77408 0
Turkey
Phone 77408 0
+902323902142
Fax 77408 0
Email 77408 0
nskocabas@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 1551 0
Therapeutics and Clinical Risk Management 2018:14 575–581
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
Results
One hundred and ninety-eight patients were enrolled in the study and 88 patients completed it. The mean age of the study population was 56.9±14.4 years (range 20–78 years), and 75% of the patients (66 patients) were male. Of these patients, 89.8% and 10.2% underwent lobectomy due to a lung tumor and bronchiectasis, respectively. Of these patients, 25% had more than one systemic disease, while 39.8% did not have any comorbid conditions. Twenty-two patients had hypertension (12 in group 1 vs 10 in group 2), 12 patients had coronary artery disease (3 in group 1 vs 9 in group 2), 10 patients had diabetes mellitus (4 in group 1 vs 6 in group 2), 18 patients had chronic obstructive pulmonary disease (6 in group 1 vs 12 in group 2), three patients had cerebrovascular disease (1 in group 1 vs 2 in group 2), 10 patients had multinodular goitre (5 in group 1 vs 5 in group 2), and 64 patients were smokers. End of surgery CVP was higher in group 2 (CVP group) than group 1 (SVV group). All patients’ end of surgery CVP levels were higher than their baseline CVP levels (9.22±3.6 mmHg vs 8±2.6 mmHg). In addition, SVV was used in fluid therapy for 48.9% of the patients. In the SVV group, 62.8% of patients (27 patients) responded to fluid therapy (fluid responsiveness was defined as an increase in SVI = 10% after fluid challenge). The mean SVV value in the SVV group was 10.5%±3.5% (4–18) at baseline and 12.2%±5.3% (2–22) after surgery. Only 25.6% of the patients had baseline SVV = 13%. The decrease in SVV during the OLV period was not significant when compared with baseline values. However, the mean SVV values during closed thoracic surgical periods were higher than values during OLV periods. The use of SVV resulted in increased use of crystalloids and colloids with increased urine output per hour. On the other hand, no significant difference in the length of hospital stay and the rate of complications was observed between the groups.
Furthermore, at least one complication occurred in 41.8% of the SVV group and 51.1% of the CVP group. The rate of respiratory complications including atelectasis, pneumonia, hypoxemia, air leak< 5 days, and increased production of secretions was 21% (n=9) in the SVV group and 37.7% (n=17) in the CVP group. Of the patients, 13.6% had an increased production of secretions, 15.9% developed atelectasis, 8% developed pneumonia,9.1% developed air leak .5 days, and 5.7% developed hypoxemia. No patient needed either tracheal intubation or mechanical ventilation. Of all patients, 5.7% developed cardiac complications and 3.4% developed acute renal failure (did not require dialysis).