Trial Review

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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 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
Sex
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
4/04/2016
Date of last participant enrolment
Anticipated
Actual
29/04/2016
Date of last data collection
Anticipated
Actual
29/04/2016
Sample size
Target
70
Accrual to date
Final
88
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
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
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
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
[email protected]
Contact person for public queries
Name 77407 0
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
[email protected]
Contact person for scientific queries
Name 77408 0
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
[email protected]

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?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.