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Trial registered on ANZCTR


Registration number
ACTRN12619000774123
Ethics application status
Approved
Date submitted
17/04/2019
Date registered
24/05/2019
Date last updated
4/02/2020
Date data sharing statement initially provided
24/05/2019
Date results information initially provided
4/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Non-Tunneled Catheter (NTC) Tip location on Chronic Kidney Disease patients undergoing Hemodialysis.
Scientific title
Does 2 vs 4 Intercostal space tip location of the Non-Tunneled Catheter tip change episode rates in Chronic Kidney Disease patients undergoing Hemodialysis?
Secondary ID [1] 297891 0
None
Universal Trial Number (UTN)
U1111-1231-9428
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End-Stage Renal Disease 312270 0
Condition category
Condition code
Renal and Urogenital 310818 310818 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The NTC will be inserted percutaneously by 2 trained nephrology fellows with the guidance of ultrasound and a modified Seldinger technique; duration of the procedure 30- 45 minutes and will be realized on an sterile environment on a designated procedure room.

The placement of the NTC tip will be randomized to the classic method located in the fourth intercostal space (4ICS) and the intervention method located in the second intercostal space (2ICS).

The Intervention position group (IG). In this group, the NTC tip will be inserted to be located on the second intercostal space (2ICS). The distance between 2ICS and the catheter entrance point (located at an imaginary traversal line that crosses the cricoid cartilage), will be measured in centimeters with a measure tape and defined as the length at which the NTC should be inserted.

The adherence to the intervention will be assed by a trained vascular nurse who will be function as an observer during the procedure and register the adherence to the established protocol.
Intervention code [1] 314219 0
Treatment: Devices
Comparator / control treatment
The Classic position group (CG). In this group, the NTC tip will be inserted to be located on the fourth intercostal space (4ICS), using the classical anthropometric measurement; this is the distance between 4ICS and the catheter entrance point (located at an imaginary traversal line that crosses the cricoid cartilage), which will be measured in centimeters with a measure tape and defined as the length at which the NTC should be inserted.
Control group
Active

Outcomes
Primary outcome [1] 319777 0
The number of dysfunction, repositioning and relocation composite episodes due to NTC tip placement on the second intercostal space versus the fourth intercostal space.

Disfunction is defined as the impossibility of the NTC to provide adequate blood flow (>250 mL/min).

Repositioning is defined as the need to accommodate the catheter because the tip of the NTC, assessed by anteroposterior radiography, is below the atrio-cava junction.

Relocation is defined as the need to remove and place a new NTC, because the tip of the NTC was lodged 1 cm above the bronchial carina, evaluated with an anteroposterior radiography.
Timepoint [1] 319777 0
48 hours post-catheter placement.
Secondary outcome [1] 369510 0
The number of dysfunction episodes due to NTC tip placement on the second intercostal space versus the fourth intercostal space.

Disfunction is defined as the impossibility of the NTC to provide adequate blood flow (>250 mL/min).
Timepoint [1] 369510 0
48 hours post-catheter placement.
Secondary outcome [2] 369511 0
The number of repositioning episodes due to NTC tip placement on the second intercostal space versus the fourth intercostal space.

Repositioning is defined as the need to accommodate the catheter because the tip of the NTC, assessed by anteroposterior radiography, is below the atrio-cava junction.
Timepoint [2] 369511 0
48 hours post-catheter placement.
Secondary outcome [3] 369512 0
The number of relocation episodes due to NTC tip placement on the second intercostal space versus the fourth intercostal space.

Relocation is defined as the need to remove and place a new NTC, because the tip of the NTC was lodged 1 cm above the bronchial carina, evaluated with an anteroposterior radiography.
Timepoint [3] 369512 0
48 hours post-catheter placement.

Eligibility
Key inclusion criteria
Inclusion criteria:
Patients over 18-years old who have accepted the placement of the NTC for hemodialysis.
Patients who have signed the informed consent.
Patients who can stay seated for the chest radiograph in a protocoled manner.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
Patients who cannot collaborate in the performance of chest PA radiography or NTC placement.
Patients who had an immediate complication during the placement, related to puncture such as pneumothorax, hemopneumothorax, catheter placement in the carotid artery, malpositioning of the NTC, hemomediastinum, air embolism.
The use of other than the right internal jugular vein for vascular access to NTC placement.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software generated by radioactive decay.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The calculated sample was determined by the ratio difference formula resulting in 153 patients, taking as reference a power of 80% and alpha of 5. The data will be reported as mean and standard deviation or median and range, accordingly to data normality distribution. To compare the standard deviation, a Fischer test will be applied in the correlation of coefficients. Confidence intervals of 95% will be used. Evaluation of qualitative variables through Chi square (tables 2x2 or 2x3) where the difference was established when the p was less than or equal to 0.05.

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] 21414 0
Mexico
State/province [1] 21414 0
Nuevo León

Funding & Sponsors
Funding source category [1] 302413 0
Hospital
Name [1] 302413 0
Hospital Universitario, Dr. José E. González, Universidad Autónoma de Nuevo León
Address [1] 302413 0
Av. Madero and Av. Gonzalitos n/n, Mitras Centro, Monterrey, Nuevo León, México, postal code 64460.
Country [1] 302413 0
Mexico
Primary sponsor type
Hospital
Name
Hospital Universitario, Dr. José E. González, Universidad Autónoma de Nuevo León
Address
Av. Madero and Av. Gonzalitos n/n, Mitras Centro, Monterrey, Nuevo León, México, postal code 64460.
Country
Mexico
Secondary sponsor category [1] 302427 0
None
Name [1] 302427 0
Address [1] 302427 0
Country [1] 302427 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303082 0
Hospital Universitario and Medicine Faculty Ethics Committee
Ethics committee address [1] 303082 0
Av. Madero and Av. Gonzalitos n/n, Mitras Centro, Monterrey, Nuevo León, México
Ethics committee country [1] 303082 0
Mexico
Date submitted for ethics approval [1] 303082 0
01/08/2017
Approval date [1] 303082 0
11/08/2017
Ethics approval number [1] 303082 0
NF17-00001

Summary
Brief summary
Non-tunnelled catheters (NTC) for hemodialysis are an indispensable vascular access in patients in need of hemodialysis, especially urgently. The insertion method used for the placement of NTC can reduce serious complications. Authors design a randomized clinical trial with adult patients of the University Hospital, of the Autonomous University of Nuevo Leon, Monterrey, Mexico, who required emergency hemodialysis by NTC. The calculated sample size is 153 patients.

The NTC will be inserted percutaneously by 2 trained nephrology fellows with the guidance of ultrasound and a modified Seldinger technique. The placement of the NTC tip will be randomized to the fourth intercostal space (4ICS) and the intervention method located in the second intercostal space (2ICS).

The main outcome is to compare the number of dysfunction, repositioning and relocation composite episodes of the NTC for Hemodialysis tip placement on the 4ICS and the 2ICS.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92406 0
Dr Héctor Raúl Ibarra Sifuentes
Address 92406 0
Hospital Universitario, "Dr Jose E. Gonzalez", Facultad de Medicina, Universidad Autónoma de Nuevo Leon, Av. Madero and Av. Gonzalitos n/n, Mitras Centro, Monterrey, Nuevo León, México, postal code 64460.
Country 92406 0
Mexico
Phone 92406 0
+52 81 8389 1111
Fax 92406 0
Email 92406 0
hector.ibarrasf@uanl.edu.mx
Contact person for public queries
Name 92407 0
Dr Héctor Raúl Ibarra Sifuentes
Address 92407 0
Hospital Universitario, "Dr Jose E. Gonzalez", Facultad de Medicina, Universidad Autónoma de Nuevo Leon, Av. Madero and Av. Gonzalitos n/n, Mitras Centro, Monterrey, Nuevo León, México, postal code 64460.
Country 92407 0
Mexico
Phone 92407 0
+52 81 8389 1111
Fax 92407 0
Email 92407 0
hector.ibarrasf@uanl.edu.mx
Contact person for scientific queries
Name 92408 0
Dr Héctor Raúl Ibarra Sifuentes
Address 92408 0
Hospital Universitario, "Dr Jose E. Gonzalez", Facultad de Medicina, Universidad Autónoma de Nuevo Leon, Av. Madero and Av. Gonzalitos n/n, Mitras Centro, Monterrey, Nuevo León, México, postal code 64460.
Country 92408 0
Mexico
Phone 92408 0
+52 81 8389 1111
Fax 92408 0
Email 92408 0
hector.ibarrasf@uanl.edu.mx

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Rate of disfunction, repositioning and relocation of the NTC tip for hemodialysis in the classic and intervention group.
When will data be available (start and end dates)?
From December 30th 2019 to December 30th 2020.
Available to whom?
Researchers who contact the corresponding author.
Available for what types of analyses?
Statistical
How or where can data be obtained?
Access subject to approvals by Principal Investigator.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary