PeritonitisNCT01621997
Different Retraining Methods vs Usual Care on the Prevention of Peritonitis in Peritoneal Dialysis
A study testing operation inspection in people with Peritonitis, run by Peking University First Hospital at 1 site in China.
Trial summary
To examine whether retraining via operation inspection or verbal education can reduce the risk for peritonitis in PD patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peritonitis
- What is being tested?
- operation inspection
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Dec 2010to Jun 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CAPD patients.
- Medically stable and receiving PD for<1 week
- age between 18 and 80 years
- self-care or doing bag exchange by a fixed assistant Exclusion Criteria
- followed up at least every 2 months
- dialyzed with glucose lactate-buffered PD solutions produced by Baxter Corp, China
Who cannot join
- Pregnancy;
- undergoing APD therapy
- Intolerance to the study protocols;
- Severe and unstable condition, acute or chronic inflammation disease;
- a high probability (assessed by the recruiting physician) of receiving a kidney transplant or transferring to HD or drop-out due to socioeconomic causes within 6 months;
- suffering peritonitis before receiving the interventions
- cognitive or psychological dysfunction;
- communication barrier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retraining Via Operation Inspection or Verbal Education vs Usual Care on the Prevention of Peritonitis in Peritoneal Dialysis
To examine whether retraining via operation inspection or verbal education can reduce the risk for peritonitis in PD patients.
Read the detailed description
The design is prospective, randomized, controlled study. At baseline (during the first month), they will receive a standard training program on performing bag exchange and education on the prevention of peritonitis.
Then the participants will be randomized into three groups: retraining via operation inspection (G1), retraining via verbal education (G2) and usual care (G3). Retraining will be performed every 2 months in G1 and G2 group.
During the following 2 years or a longer period, all the participants will be followed up frequently with outcome events recorded.
- Conditions
- Peritonitis
- Being tested
- operation inspection
- Keywords
- peritoneal dialysis, retraining, peritonitis
- Medical subject headings
- Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
operation inspectionBehavioural
Retraining via operation inspection means that nurses check if patients can follow the taught skill during the procedure of bag exchange and correct wrong steps in one-to-one way every 2 months.
Retraining via verbal education means that nurses remind patients of key points of bag exchange through interactive quiz derived from above checklist every 2 months till 24 months
| Study group | Role | What they receive |
|---|---|---|
| operation inspection | Experimental | During retraining the patients performed bag exchange under the supervision of a nurse. The nurse ensured that each error listed in the NAC form should be avoided, thus immediately corrected any wrong steps if only. Receives: Behavioral: operation inspection |
| verbal education | Experimental | Patients in the oral education group also underwent retraining every 2 months. A nurse would address all items in the NAC form one by one, to remind the patient of the key points of bag exchange. Scores calculated by the sum of error items during the bag exchange for patients in technique inspection group, or by the sum of "yes" in the interactive quiz for patients in verbal education group. Receives: Behavioral: operation inspection |
| usual care | Experimental | Patients in the usual care group did not receive any retraining Receives: Behavioral: operation inspection |
What is being measured
The primary outcome is the main question the study is designed to answer.
first-episode peritonitis
Infection rates were calculated as the number of infections divided by the total time at risk, and expressed as episodes per 100 patient-years at risk.
Measured: 48 months
Secondary outcomes (2)
first-episode enteric peritonitis,first-episode non-enteric peritonitis
Enteric organisms included enterococcus and enterobacter.
Measured: 48 moths
transition transition to haemodialysis, and all-cause death.
transition to haemodialysis, and all-cause death.
Measured: 48 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startDec 2010
- Primary completionJun 2018
- Study completionJun 2018
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 PeritonitisStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Jie, Peking University First Hospital
- Investigators
- Jie Dong, MD,PhD,, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621997
- Sponsor's protocol ID
- PD TRAINING
- Status last verified
- Jul 2019
- First submitted
- 14 Jun 2012
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Xu Y, Zhang Y, Yang B, Luo S, Yang Z, Johnson DW, Dong J. Prevention of peritoneal dialysis-related peritonitis by regular patient retraining via technique inspection or oral education: a randomized controlled trial. Nephrol Dial Transplant. 2020 Apr 1;35(4):676-686. doi: 10.1093/ndt/gfz238.
PubMed 31821491
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retraining Via Operation Inspection or Verbal Education vs Usual Care on the Prevention of Peritonitis in Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT01621997
- Acronym / sponsor ID
- PD TRAINING
- Conditions
- Peritonitis
- Keywords
- peritoneal dialysis, retraining, peritonitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 18 Jun 2012 (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.
To examine whether retraining via operation inspection or verbal education can reduce the risk for peritonitis in PD patients.
Detailed description
The design is prospective, randomized, controlled study. At baseline (during the first month), they will receive a standard training program on performing bag exchange and education on the prevention of peritonitis.
Then the participants will be randomized into three groups: retraining via operation inspection (G1), retraining via verbal education (G2) and usual care (G3). Retraining will be performed every 2 months in G1 and G2 group.
During the following 2 years or a longer period, all the participants will be followed up frequently with outcome events recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| operation inspection | Experimental | Behavioral: operation inspectionDuring retraining the patients performed bag exchange under the supervision of a nurse. The nurse ensured that each error listed in the NAC form should be avoided, thus immediately corrected any wrong steps if only. |
| verbal education | Experimental | Behavioral: operation inspectionPatients in the oral education group also underwent retraining every 2 months. A nurse would address all items in the NAC form one by one, to remind the patient of the key points of bag exchange. Scores calculated by the sum of error items during the bag exchange for patients in technique inspection group, or by the sum of "yes" in the interactive quiz for patients in verbal education group. |
| usual care | Experimental | Behavioral: operation inspectionPatients in the usual care group did not receive any retraining |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- CAPD patients.
- Medically stable and receiving PD for<1 week
- age between 18 and 80 years
- self-care or doing bag exchange by a fixed assistant Exclusion Criteria
- followed up at least every 2 months
Key exclusion criteria (8 listed)
- Pregnancy;
- undergoing APD therapy
- Intolerance to the study protocols;
- Severe and unstable condition, acute or chronic inflammation disease;
- a high probability (assessed by the recruiting physician) of receiving a kidney transplant or transferring to HD or drop-out due to socioeconomic causes within 6 months;
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 |
|---|---|---|
| operation inspectionRetraining via operation inspection means that nurses check if patients can follow the taught skill during the procedure of bag exchange and correct wrong steps in one-to-one way every 2 months. Retraining via verbal education means that nurses remind patients of key points of bag exchange through interactive quiz derived from above checklist every 2 months till 24 months | Behavioural | operation inspection, usual care, verbal education |
Primary outcome
first-episode peritonitis
Time frame: 48 months
Infection rates were calculated as the number of infections divided by the total time at risk, and expressed as episodes per 100 patient-years at risk.
2 secondary outcomes
first-episode enteric peritonitis,first-episode non-enteric peritonitis
Time frame: 48 moths
transition transition to haemodialysis, and all-cause death.
Time frame: 48 moths
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 Aug 2020.
- Derived from this study: PubMed 31821491Xu Y, Zhang Y, Yang B, Luo S, Yang Z, Johnson DW, Dong J. Prevention of peritoneal dialysis-related peritonitis by regular patient retraining via technique inspection or oral education: a randomized controlled trial. Nephrol Dial Transplant. 2020 Apr 1;35(4):676-686. doi: 10.1093/ndt/gfz238.
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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.
Jie Dong, MD,PhD, principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing operation inspection in people with Peritonitis, run by Peking University First Hospital at 1 site in China.
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 6 inclusion and 8 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 Aug 2020. 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 China. 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?
first-episode peritonitis (time frame: 48 months). 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 NCT01621997, 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 28 Aug 2020.