Peritoneal Dialysis Catheter InfectionNCT03798171
Reduction of Exit Site Infection in Peritoneal Dialysis Patients
An observational study of Peritoneal Dialysis Catheter Infection, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
In peritoneal dialysis patients, the presence of the catheter presents a risk of infection - exit site infection, tunnel infection or peritonitis. In our dialysis unit, we noticed a rise in exit-site infection associated with organisms derived from contaminated water. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Peritoneal Dialysis Catheter Infection
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 15 May 2018to 15 May 2021
- 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: peritoneal dialysis patients in Tel Aviv Sourasky medical center
Who may be able to join
- peritoneal dialysis patients capable to sign an informed consent or have an official guardian
Who cannot join
- patient's refusal
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Canter
Tel Aviv
Orit Kliuk Ben Bassat, MD, 97236973270, oritkl@tlvmc.gov.il
About this study
In peritoneal dialysis patients, the presence of the catheter presents a risk of infection - exit site infection, tunnel infection or peritonitis. In our dialysis unit, we noticed a rise in exit-site infection associated with organisms derived from contaminated water. Therefore we decided to change the exit-site care in our unit.
This is a prospective observational single center study, that compares exit-site infection rated in peritoneal dialysis patients before and after our policy change for exit-site care.
Read the detailed description
Peritoneal dialysis is a method for renal replacement therapy that uses the peritoneal membrane for exchange of fluids and dissolved substance . A catheter is surgically inserted with one end in the abdomen and the other protruding from the skin, in order to allow fluid exchange.
The presence of the catheter presents a risk of infection - exit site infection, tunnel infection or peritonitis - a cause of morbidity and treatment failure.
Infection prevention is based, among other measures, on aseptic handeling of catheter exit-site. In our dialysis unit, we noticed a rise in pseudomonas exit-site infection and other organisms associated with contaminated water. Therefore we decided to change the exit-site care in our unit. Similar to central catheters handeling, we decided to cover the catheter exit-site during water exposure, and to change the prophylactic exit-site antibiotic regimen.
This is a prospective observational single center study. All peritoneal dialysis patients in our institue will be counseled about change in exit-site care. For prevention of water exposure the patients will use stoma bags around the catheter during showers. After the shower, the exit-site is cleaned with a chlorhexidine based solution, an antibiotic cream is applied (Mupirocin) and dressed with a clean gauze.
The patients will be followed for 3 years for adverse events. The number of infectious episodes will be recorded and compared to historical data (January 2015-December 2017).
- Conditions
- Peritoneal Dialysis Catheter Infection
- Keywords
- peritoneal dialysis, exit site, infection, peritonitis
- Medical subject headings
- Infections, Peritonitis
What is being measured
The primary outcome is the main question the study is designed to answer.
exit-site infection rate
number of exit-site infection during 3 years of follow up, compared to historical data
Measured: 36 months
Secondary outcomes (1)
peritonitis rate
number of peritonitis episodes during 3 years of follow up, compared to historical data
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start15 May 2018
- Primary completion15 May 2021 (estimated)
- Study completion15 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis Catheter InfectionStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798171
- Sponsor's protocol ID
- 0077-18-TLV
- Status last verified
- Jan 2019
- First submitted
- 7 Jan 2019
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Exit Site Infection in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT03798171
- Acronym / sponsor ID
- 0077-18-TLV
- Conditions
- Peritoneal Dialysis Catheter Infection
- Keywords
- peritoneal dialysis, exit site, infection, peritonitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 15 May 2018 (actual)
- Primary completion
- 15 May 2021 (estimated)
- Study completion
- 15 May 2021 (estimated)
- First posted
- 9 Jan 2019 (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.
In peritoneal dialysis patients, the presence of the catheter presents a risk of infection - exit site infection, tunnel infection or peritonitis. In our dialysis unit, we noticed a rise in exit-site infection associated with organisms derived from contaminated water. Therefore we decided to change the exit-site care in our unit.
This is a prospective observational single center study, that compares exit-site infection rated in peritoneal dialysis patients before and after our policy change for exit-site care.
Detailed description
Peritoneal dialysis is a method for renal replacement therapy that uses the peritoneal membrane for exchange of fluids and dissolved substance . A catheter is surgically inserted with one end in the abdomen and the other protruding from the skin, in order to allow fluid exchange.
The presence of the catheter presents a risk of infection - exit site infection, tunnel infection or peritonitis - a cause of morbidity and treatment failure.
Infection prevention is based, among other measures, on aseptic handeling of catheter exit-site. In our dialysis unit, we noticed a rise in pseudomonas exit-site infection and other organisms associated with contaminated water. Therefore we decided to change the exit-site care in our unit. Similar to central catheters handeling, we decided to cover the catheter exit-site during water exposure, and to change the prophylactic exit-site antibiotic regimen.
This is a prospective observational single center study. All peritoneal dialysis patients in our institue will be counseled about change in exit-site care. For prevention of water exposure the patients will use stoma bags around the catheter during showers. After the shower, the exit-site is cleaned with a chlorhexidine based solution, an antibiotic cream is applied (Mupirocin) and dressed with a clean gauze.
The patients will be followed for 3 years for adverse events. The number of infectious episodes will be recorded and compared to historical data (January 2015-December 2017).
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
- peritoneal dialysis patients in Tel Aviv Sourasky medical center
Key inclusion criteria (1 listed)
- peritoneal dialysis patients capable to sign an informed consent or have an official guardian
Key exclusion criteria (1 listed)
- patient's refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
exit-site infection rate
Time frame: 36 months
number of exit-site infection during 3 years of follow up, compared to historical data
1 secondary outcome
peritonitis rate
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
Related trials for Peritoneal Dialysis Catheter Infection
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Silver-Impregnated Dressings for Catheter Exit-Site and Tunnel Infections in Peritoneal Dialysis Patients
Peritoneal Dialysis Catheter Exit Site Infection, Peritoneal Dialysis Catheter Tunnel Infection
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.
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 Peritoneal Dialysis Catheter Infection, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Jan 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exit-site infection rate (time frame: 36 months). 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 9 Jan 2019.