NCT03727581

Brief Summary

The aim of the project is to check if there is a possibility for a nephrologist to visualise the guidewire by means of available ultrasound scanners. To evaluate that, the procedure of catheter insertion will be expanded by ultrasound examination of right atrium and inferior vena cava border using substernal view. Such imaging seems to ameliorate the safety of catheter implementation and could be a good alternative for fluoroscopy, eliminating its adverse effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

October 30, 2018

Last Update Submit

March 27, 2019

Conditions

Keywords

hemodialysisvascular accessdialysis catheter

Outcome Measures

Primary Outcomes (2)

  • Successful guidewire insertion

    Visualization of guidewire in right atrium-inferior vena cava junction

    5 minutes

  • Successful catheter placement

    Catheter tip in lower part of superior vena cava or right atrium on chest x-ray. Good catheter function.

    2 hours

Secondary Outcomes (1)

  • Complication rate

    24 hours

Interventions

Ultrasound guidanceDIAGNOSTIC_TEST

Jugular vein is punctured with ultrasound guidance and guidewire is advanced. Right atrium and inferior vena cava junction is visualized by ultrasound using substernal view. Presence of guidewire in inferior vena cava or right atrium is confirmed. The procedure of catheter insertion is continued.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute kidney disease or end stage renal disease who need dialysis catheter insertion for hemodialysis performance

You may qualify if:

  • Renal failure requiring hemodialysis through a dialysis catheter
  • Capable of giving informed consent
  • Placement of internal jugular vein catheter

You may not qualify if:

  • Inability to provide informed consent
  • Poor visualisation of inferior vena cava

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nephrology and Transplantation Medicine

Wroclaw, 55-556, Poland

Location

MeSH Terms

Conditions

Acute Kidney InjuryKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal Insufficiency, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Krzysztof Letachowicz, MD, PhD

    Wroclaw Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 30, 2018

First Posted

November 1, 2018

Study Start

May 28, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

March 28, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations