Renal FailureNCT01023191
Open Versus Percutaneous Insertion of CAPD Catheters
A study testing Percutaneous Insertion catheter and Open insertion Catheter in people with Renal Failure, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Healthy kidneys clean your blood by removing excess fluid, minerals, and wastes. When your kidneys fail, harmful wastes build up in your body and your body may retain excess fluid. When this happens, you need treatment to replace the work of your failed kidneys. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure
- What is being tested?
- Percutaneous Insertion catheter and Open insertion Catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2015to Sep 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Potential participating patients will be identified by referral to the vascular surgery department for insertion of CAPD catheter for peritoneal access.
Specific inclusion criteria necessary for invitation to study participation;
- Patients referred to vascular consultants for CAPD catheter insertion
General inclusion criteria:
- Ability to give informed written consent
Specific exclusion criteria:
- Previous abdominal surgery via midline incision
- Unfit for general anaesthetic
- Aged under 18 at time of referral
General exclusion criteria:
- Inability to give informed written consent
- Inability to attend follow up appointments
Withdrawal criteria:
- Patient request
- Patient non compliance with study protocol
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hull Royal Infirmary
Hull, East Yorkshire, HU3 2JZ
About this study
Official title: A Prospective Randomized Controlled Trial of Local Anaesthetic Percutaneous Insertion Versus General Anaesthetic Open Surgical Placement of Continuous Peritoneal Dialysis Catheters in a University Teaching Hospital
Healthy kidneys clean your blood by removing excess fluid, minerals, and wastes. When your kidneys fail, harmful wastes build up in your body and your body may retain excess fluid. When this happens, you need treatment to replace the work of your failed kidneys. This may be with a dialysis machine using haemodialysis or with fluid in the abdomen or peritoneal dialysis.
In peritoneal dialysis, a tube called a catheter is put in the abdomen wall and used to fill your abdomen with a cleansing liquid called dialysis solution. The walls of your abdominal cavity are lined with a membrane called the peritoneum, which allows waste products and extra fluid to pass from your blood into the dialysis solution. These wastes and fluid are removed from the body when the dialysis fluid is drained and replaced with a fresh solution.
Read more
The tubes or catheters used to exchange the fluid are currently positioned using a general anaesthetic (with the patient awake) and an operation with a cut under the belly button. Newer techniques using local anaesthetic (with the patient awake and the area numbed) and requiring only a small cut in the skin have been used. No one has ever directly compared the two techniques.
The investigators aim is to perform a direct comparison between the two techniques to look at the complications and time required for surgery and length of hospital stay required. The investigators will also look at the patients satisfaction and pain scores with each technique to help gather evidence as to which is likely to be the best technique to use from now on.
- Conditions
- Renal Failure
- Being tested
- Percutaneous Insertion catheter, Open insertion Catheter
- Keywords
- Dialysis, Peritoneal, Catheter, Surgery
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Insertion catheterProcedure or surgery
Insertion of CAPD catheter using percutaneous seldinger technique under local anaesthetic +/- sedation as required
Open insertion CatheterProcedure or surgery
Present technique of open insertion under general anaesthetic. Incision to lower abdomen and direct visualisation of catheter tip placement into pelvis.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous insertion | Active comparator | To undergo insertion of catheter using percutaneous technique under local anaesthetic Receives: Procedure: Percutaneous Insertion catheter |
| Open insertion | Active comparator | To undergo insertion of catheter using open technique under general anaesthetic Receives: Procedure: Open insertion Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter survival
Time to catheter removal for any reason.recorded as percentage inn situ at 6, 12,18,etc months post procedure.
Measured: Ongoing (recorded at 6 month intervals)
Secondary outcomes (9)
Peri operative complications (bleeding, bowel injury)
All complications occuring at time of procedure and in 24 hours immediately post procedure.
Measured: 24 hrs post procedure
Mechanical Complication (drainage failure, displacement, fluid leak)
All mechanical complications recorded during follow up period. Note of timing of complications will be made in results. Early = within 30 days, late = beyond 30 days
Measured: ongoing (reported at 30 days and monthly thereafter)
Infective complications (exit site, tunnel, peritonitis)
All infective complications recorded during follow up period. Note of timing of complications will be made in results. Early = within 30 days, late = beyond 30 days
Measured: ongoing (reported at 30 days and monthly thereafter)
Operative time
Time to complete procedure from start to finish.
Measured: Average of 2 hours post procedure
Technical Success of placement
Assessment of whether a working and useable catheter is in situ at the end of the procedure.
Measured: Average of 2 hours post procedure
Length of admission
Length of admission post procedure according to strict discharge criteria.
Measured: Average of 48 hours post procedure
Patient reported pain post procedure
Analgesia and daily pain scoring diaries will be issued to patients post procedure. These will record patient reported pain at 24 hour intervals to 5 days as well as analgesia taken during the same period.
Measured: 24 hour intervals to 5 days post procedure
Quality of life assessment by questionnaire
Measured: Within 24 hours prior to procedure, and again at both 5 days and 3 months post procedure
Estimated cost of care episode
Overall estimated cost of admission, procedure, ongoing care of catheter and management of complications arising from catheter or procedure will be calculated.
Measured: 3 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startFeb 2015
- Primary completionJul 2018 (estimated)
- Study completionSep 2018 (estimated)
Why it stopped: Did not pass set-up phase
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Hull
- Responsible party
- Sponsor
- Investigators
- Ian C Chetter, MB ChB, Principal investigator, University of Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023191
- Sponsor's protocol ID
- Access 3
- Status last verified
- Jul 2019
- First submitted
- 1 Dec 2009
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Briggs VR, Jacques RM, Fotheringham J, Maheswaran R, Campbell M, Wilkie ME. Catheter insertion techniques for improving catheter function and clinical outcomes in peritoneal dialysis patients. Cochrane Database Syst Rev. 2023 Feb 22;2(2):CD012478. doi: 10.1002/14651858.CD012478.pub2.
PubMed 36810986
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Local Anaesthetic Percutaneous Insertion Versus General Anaesthetic Open Surgical Placement of Continuous Peritoneal Dialysis Catheters in a University Teaching Hospital
- ClinicalTrials.gov ID
- NCT01023191
- Acronym / sponsor ID
- Access 3
- Conditions
- Renal Failure
- Keywords
- Dialysis, Peritoneal, Catheter, Surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not pass set-up phase
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- University of Hull
- Study start
- Feb 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 2 Dec 2009 (estimated)
- 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.
Healthy kidneys clean your blood by removing excess fluid, minerals, and wastes. When your kidneys fail, harmful wastes build up in your body and your body may retain excess fluid. When this happens, you need treatment to replace the work of your failed kidneys. This may be with a dialysis machine using haemodialysis or with fluid in the abdomen or peritoneal dialysis.
In peritoneal dialysis, a tube called a catheter is put in the abdomen wall and used to fill your abdomen with a cleansing liquid called dialysis solution. The walls of your abdominal cavity are lined with a membrane called the peritoneum, which allows waste products and extra fluid to pass from your blood into the dialysis solution. These wastes and fluid are removed from the body when the dialysis fluid is drained and replaced with a fresh solution.
The tubes or catheters used to exchange the fluid are currently positioned using a general anaesthetic (with the patient awake) and an operation with a cut under the belly button. Newer techniques using local anaesthetic (with the patient awake and the area numbed) and requiring only a small cut in the skin have been used. No one has ever directly compared the two techniques.
The investigators aim is to perform a direct comparison between the two techniques to look at the complications and time required for surgery and length of hospital stay required. The investigators will also look at the patients satisfaction and pain scores with each technique to help gather evidence as to which is likely to be the best technique to use from now on.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous insertion | Active comparator | Procedure: Percutaneous Insertion catheterTo undergo insertion of catheter using percutaneous technique under local anaesthetic |
| Open insertion | Active comparator | Procedure: Open insertion CatheterTo undergo insertion of catheter using open technique under general anaesthetic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Percutaneous Insertion catheterInsertion of CAPD catheter using percutaneous seldinger technique under local anaesthetic +/- sedation as required | Procedure or surgery | Percutaneous insertion |
| Open insertion CatheterPresent technique of open insertion under general anaesthetic. Incision to lower abdomen and direct visualisation of catheter tip placement into pelvis. | Procedure or surgery | Open insertion |
Primary outcome
Catheter survival
Time frame: Ongoing (recorded at 6 month intervals)
Time to catheter removal for any reason.recorded as percentage inn situ at 6, 12,18,etc months post procedure.
9 secondary outcomes
Peri operative complications (bleeding, bowel injury)
Time frame: 24 hrs post procedure
Mechanical Complication (drainage failure, displacement, fluid leak)
Time frame: ongoing (reported at 30 days and monthly thereafter)
Infective complications (exit site, tunnel, peritonitis)
Time frame: ongoing (reported at 30 days and monthly thereafter)
Operative time
Time frame: Average of 2 hours post procedure
Technical Success of placement
Time frame: Average of 2 hours post procedure
Length of admission
Time frame: Average of 48 hours post procedure
Patient reported pain post procedure
Time frame: 24 hour intervals to 5 days post procedure
Quality of life assessment by questionnaire
Time frame: Within 24 hours prior to procedure, and again at both 5 days and 3 months post procedure
Estimated cost of care episode
Time frame: 3 months post procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Derived from this study: PubMed 36810986Briggs VR, Jacques RM, Fotheringham J, Maheswaran R, Campbell M, Wilkie ME. Catheter insertion techniques for improving catheter function and clinical outcomes in peritoneal dialysis patients. Cochrane Database Syst Rev. 2023 Feb 22;2(2):CD012478. doi: 10.1002/14651858.CD012478.pub2.
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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.
Ian C Chetter, MB ChB principal investigator
University of Hull
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Insertion catheter and Open insertion Catheter in people with Renal Failure, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 22 Jul 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 United Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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?
Catheter survival (time frame: Ongoing (recorded at 6 month intervals)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01023191, which also lists 1 linked publication.
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 22 Jul 2019.