ANZCTR - Registration

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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

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]

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

Condition category

Condition code

Renal and Urogenital

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]

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]

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]

48 hours post-catheter placement.

Secondary outcome [1]

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]

48 hours post-catheter placement.

Secondary outcome [2]

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]

48 hours post-catheter placement.

Secondary outcome [3]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

30/05/2019

Actual

30/05/2019

Date of last participant enrolment

Anticipated

11/11/2019

Actual

15/01/2020

Date of last data collection

Anticipated

30/12/2019

Actual

17/01/2020

Sample size

Target

153

Accrual to date

Final

165

Recruitment outside Australia

Country [1]

Mexico

State/province [1]

Nuevo León

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Hospital Universitario, Dr. José E. González, Universidad Autónoma de Nuevo León

Address [1]

Av. Madero and Av. Gonzalitos n/n, Mitras Centro, Monterrey, Nuevo León, México, postal code 64460.

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hospital Universitario and Medicine Faculty Ethics Committee

Ethics committee address [1]

Av. Madero and Av. Gonzalitos n/n, Mitras Centro, Monterrey, Nuevo León, México

Ethics committee country [1]

Mexico

Date submitted for ethics approval [1]

01/08/2017

Approval date [1]

11/08/2017

Ethics approval number [1]

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

Dr Héctor Raúl Ibarra Sifuentes

Address

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

Mexico

Phone

+52 81 8389 1111

Fax

[email protected]

Contact person for public queries

Name

Héctor Raúl Ibarra Sifuentes

Address

Country

Mexico

Phone

+52 81 8389 1111

Fax

[email protected]

Contact person for scientific queries

Name

Héctor Raúl Ibarra Sifuentes

Address

Country

Mexico

Phone

+52 81 8389 1111

Fax

[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?

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 Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Non-tunneled catheter tip depth position in urgent hemodialysis: a randomized controlled trial.	2023	https://dx.doi.org/10.23736/S2724-6051.21.04222-1

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically