Kidney Failure, AcuteNCT03727581
Ultrasound for Guidewire Detection
An observational study of Kidney Failure, Acute and Kidney Failure, Chronic, run by Wroclaw Medical University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Kidney Failure, Acute, Kidney Failure, Chronic
- What is being tested?
- Ultrasound guidance
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 28 May 2018to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute kidney disease or end stage renal disease who need dialysis catheter insertion for hemodialysis performance
Who may be able to join
- Renal failure requiring hemodialysis through a dialysis catheter
- Capable of giving informed consent
- Placement of internal jugular vein catheter
Who cannot join
- Inability to provide informed consent
- Poor visualisation of inferior vena cava
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Nephrology and Transplantation Medicine
Wroclaw, 55-556
About this study
Official title: Dialysis Catheter Insertion With Substernal Ultrasound Guidance
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.
- Conditions
- Kidney Failure, Acute, Kidney Failure, Chronic
- Being tested
- Ultrasound guidance
- Keywords
- hemodialysis, vascular access, dialysis catheter
- Medical subject headings
- Acute Kidney Injury, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful guidewire insertion
Visualization of guidewire in right atrium-inferior vena cava junction
Measured: 5 minutes
Successful catheter placement
Catheter tip in lower part of superior vena cava or right atrium on chest x-ray. Good catheter function.
Measured: 2 hours
Secondary outcomes (1)
Complication rate
Presence of pneumothorax, hematoma, catheter dysfunction
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start28 May 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krzysztof Letachowicz, Wroclaw Medical University
- Investigators
- Krzysztof Letachowicz, MD, PhD, Principal investigator, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727581
- Sponsor's protocol ID
- st40
- Status last verified
- Mar 2019
- First submitted
- 30 Oct 2018
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialysis Catheter Insertion With Substernal Ultrasound Guidance
- ClinicalTrials.gov ID
- NCT03727581
- Acronym / sponsor ID
- st40
- Conditions
- Kidney Failure, Acute, Kidney Failure, Chronic
- Keywords
- hemodialysis, vascular access, dialysis catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 28 May 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute kidney disease or end stage renal disease who need dialysis catheter insertion for hemodialysis performance
Key inclusion criteria (3 listed)
- Renal failure requiring hemodialysis through a dialysis catheter
- Capable of giving informed consent
- Placement of internal jugular vein catheter
Key exclusion criteria (2 listed)
- Inability to provide informed consent
- Poor visualisation of inferior vena cava
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guidanceJugular 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. | Diagnostic test | – |
Primary outcome
Successful guidewire insertion
Time frame: 5 minutes
Visualization of guidewire in right atrium-inferior vena cava junction
Successful catheter placement
Time frame: 2 hours
Catheter tip in lower part of superior vena cava or right atrium on chest x-ray. Good catheter function.
1 secondary outcome
Complication rate
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Kidney Failure, Acute
RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Not yet recruitingObservational study
Effect of Filter Lifespan in CRRT on New Infections in Critically Ill Patients With AKI
Acute Kidney Injury
Enrolling by invitationObservational study
ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA)
Acute Kidney Injury
Recruiting
LoW Dose-Intensity vs. Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients (WISDOM)
Acute Kidney Injury, Dialysis; Complications
Not yet recruiting
Effects of Horticultural Therapy on Acute Stress and Salivary Cortisol Levels in Hemodialysis Patients
End-Stage Renal Disease, Renal Dialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krzysztof Letachowicz, MD, PhD principal investigator
Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Acute and Kidney Failure, Chronic, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful guidewire insertion (time frame: 5 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.