Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000061134
Ethics application status
Approved
Date submitted
10/09/2018
Date registered
17/01/2019
Date last updated
17/01/2019
Date data sharing statement initially provided
17/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Duration of operation and cross-clamp time relative to cystatin C level of early-onset renal insufficiency in patients undergoing coronary artery bypass graft surgery,
Scientific title
Duration of operation and cross-clamp time relative to cystatin C level of early-onset renal insufficiency in patients undergoing coronary artery bypass graft surgery,
Secondary ID [1] 296015 0
Nil known
Universal Trial Number (UTN)
U1111-1220-0363
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
coronary artery bypass surgery 309548 0
renal insufficiency 309549 0
Condition category
Condition code
Anaesthesiology 308369 308369 0 0
Other anaesthesiology
Surgery 308370 308370 0 0
Other surgery
Cardiovascular 308371 308371 0 0
Coronary heart disease
Renal and Urogenital 308372 308372 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1-2 µg / kg of fentanyl, 2-3 mg / kg of propofol and 0.6 mg / kg of rocuronium will be administered intravenously during induction of anesthesia. After 2 minutes the patient will be intubated. Central vein catheterization will be performed from right jugular vein. At this time, 5 ml of blood will be taken for cystatin C level and sent to the laboratory. Anticoagulation with 300 IU / kg heparin will be administered intravenously to enter the cardiopulmonary bypass.
ACT (activated clotting time) values will be checked with ACT measurement device by periodic measurements for 30 minutes until cardiopulmonary bypass is stopped and cannulas are withdrawn.
Hourly urine output, mediastinal drainage volume, duration of extubation will be noted. Blood samples for hemogram, BUN, creatine and cystatin C measurements will be taken at the 2nd and 24th hours postoperatively and sent to the laboratory.
Blood samples taken for cystatin C will be stored at -80 ° C until assay time after centrifugation.
Anesthesists will perform processes in the operating room and intensive care unit.
Bioscience specialist will perform the processes in the laboratory
Bypass operation will last for almost 3-4 hours and in intensive care unit hourly urine output, mediastinal drainage volume, duration of extubation, intraoperative and postoperative blood and blood product amounts given in the first 24 hours will be noted by anesthesists.
Intervention code [1] 312352 0
Early detection / Screening
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307350 0
changes in blood cystatin c levels during timepoints
Timepoint [1] 307350 0
preoperative, postoperative 2 hour (primary timepoint) and postoperative 24 hours
Primary outcome [2] 307592 0
changes in blood creatine levels during timepoints
Timepoint [2] 307592 0
preoperative, postoperative 2 hour( primary timepoint) and postoperative 24 hours
Secondary outcome [1] 351560 0
Measurement of the operation time in minutes with the stopwatch
Timepoint [1] 351560 0
time between start and end of operation
Secondary outcome [2] 352376 0
measurement of the time until the removal of cross clamp with the stopwatch
Timepoint [2] 352376 0
time between start and end of operation
Secondary outcome [3] 352377 0
measurement of urine output in ml by weighing of urinary catheter bag,
Timepoint [3] 352377 0
hourly urine output over a 24-hour period
Secondary outcome [4] 354554 0
measurement of mediastinal drainage volume in ml by weighing of mediastinal chest tube
Timepoint [4] 354554 0
mediastinal drainage volume over a 24-hour period
Secondary outcome [5] 354555 0
measurement of the time between taking the patient to the intensive care unit and extubating with the stopwatch
Timepoint [5] 354555 0
as long as the patient is in intensive care
Secondary outcome [6] 354931 0
changes in blood urine nitrogen (BUN) levels during timepoints
Timepoint [6] 354931 0
preoperative, postoperative 2 hour( primary timepoint) and postoperative 24 hours

Eligibility
Key inclusion criteria
Patients undergoing coronary artery bypass graft surgery,
Patients with normal renal function, elective surgery
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
emergent surgery, pregnancy, patients undergoing heart valve surgery, diabetic nephropathy

Study design
Purpose of the study
Diagnosis
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
Type of endpoint/s
Statistical methods / analysis
The data will be analyzed with SPSS for Windows version 23.0. Mean, standard deviation in descriptive statistics of continuous variables; categorical variables will be expressed in numbers and percentages. The significance of the difference between groups for categorical variables will be evaluated by Chi-square test. Student's t-test was used for normal distribution in the binary group comparisons, Mann Whitney-U test in the non-normal range, and Krukall Wallis test and Bonferoni correction in more than one group. Correlation of continuous variables will be assessed by Pearson Rho correlation in normal scattering data and Spearman correlation test in normal scattering. A value of p <0.05 will be considered statistically significant

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/11/2018
Date of last participant enrolment
Anticipated
10/03/2019
Actual
Date of last data collection
Anticipated
10/04/2019
Actual
Sample size
Target
40
Accrual to date
10
Final
Recruitment outside Australia
Country [1] 21001 0
Turkey
State/province [1] 21001 0
Sanliurfa

Funding & Sponsors
Funding source category [1] 300609 0
Self funded/Unfunded
Name [1] 300609 0
Country [1] 300609 0
Primary sponsor type
Individual
Name
Mehmet Tercan
Address
Health Sciences University Sanliurfa Mehmet Akif Inan Education Research Hospital, Ertugrul Street, Esentepe 63300, Haliliye, Sanliurfa, Turkey
Country
Turkey
Secondary sponsor category [1] 300114 0
Individual
Name [1] 300114 0
Gülçin Patmano
Address [1] 300114 0
Health Sciences University Sanliurfa Mehmet Akif Inan Education Research Hospital, Ertugrul Street, Esentepe 63300, Haliliye, Sanliurfa, Turkey
Country [1] 300114 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301395 0
Harran University medical faculty ethics committee
Ethics committee address [1] 301395 0
Ethics committee country [1] 301395 0
Turkey
Date submitted for ethics approval [1] 301395 0
25/05/2018
Approval date [1] 301395 0
07/06/2018
Ethics approval number [1] 301395 0
74059997-050.04.04

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86862 0
Dr Mehmet Tercan
Address 86862 0
Health Sciences University Sanliurfa Mehmet Akif Inan Education Research Hospital, Ertugrul Street, Esentepe 63300, Haliliye, Sanliurfa, Turkey
Country 86862 0
Turkey
Phone 86862 0
+905323445635
Fax 86862 0
Email 86862 0
[email protected]
Contact person for public queries
Name 86863 0
Mehmet Tercan
Address 86863 0
Health Sciences University Sanliurfa Mehmet Akif Inan Education Research Hospital, Ertugrul Street, Esentepe 63300, Haliliye, Sanliurfa, Turkey
Country 86863 0
Turkey
Phone 86863 0
+905323445635
Fax 86863 0
Email 86863 0
[email protected]
Contact person for scientific queries
Name 86864 0
Mehmet Tercan
Address 86864 0
Health Sciences University Sanliurfa Mehmet Akif Inan Education Research Hospital, Ertugrul Street, Esentepe 63300, Haliliye, Sanliurfa, Turkey
Country 86864 0
Turkey
Phone 86864 0
+905323445635
Fax 86864 0
Email 86864 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
Beginning 4 months and ending 6 years following main results publication
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
requirement to sign data access agreement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.