Peritoneal InfectionNCT06536673
Intervention to Reduce Infectious Complications of Peritoneal Dialysis
A study testing Intervention to reduce infectious complications of peritoneal dialysis and Data collection from the patient's clinical history in people with Peritoneal Infection, run by Universitat de Lleida.
Trial summary
Peritonitis is a common and serious complication of peritoneal dialysis (PD) and is one of the main causes of peritoneal dialysis technique failure and long-term hemodialysis conversion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Infection
- What is being tested?
- Intervention to reduce infectious complications of peritoneal dialysis and Data collection from the patient's clinical history
- 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
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2024to 1 Sep 2025
- 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
Who may be able to join
- Patients >18 years of age
- Medically stable
- Who can perform dialysis themselves or with the help of a caregiver willing to participate in the study and sign the informed consent will be included
Who cannot join
- Patients with psychiatric, psychological disorders and social (language barrier included)
- Who do not have a formal/informal caregiver
- Those who due to medical needs cannot continue with the standard schedule, pregnant women, participants who suffered peritonitis before receiving the educational intervention
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Educational Intervention Aimed At Reducing Infectious Complications Related to Peritoneal Dialysis
Peritonitis is a common and serious complication of peritoneal dialysis (PD) and is one of the main causes of peritoneal dialysis technique failure and long-term hemodialysis conversion.
Read the detailed description
Peritoneal infections (PI) have been a very relevant representative of peritoneal dialysis (PD) for decades. PI is a very serious complication of PD and is a source of concern because of its high incidence. Each episode carries clinical consequences for the patient, increases in treatment costs, hospital admissions, technical failures and risk of death, especially in the 30 days following an episode.
The risk of peritonitis depends on non-modifiable factors (such as age, sex, diabetes) and modifiable factors (such as anti-infective prophylaxis, catheter care, and training).
It is important to accurately analyze the effect of modifiable factors, as they are the most relevant in reducing the rate of peritonitis.
Patient education is very important and can affect the success of the technique and clinical results. Therapeutic education has been considered a key factor in PD outcomes.
The PD nurse is responsible for training the patient and/or caregiver to be self-sufficient and autonomous in care, reinforce and highlight the importance of adherence to treatment, and promote safe actions to prevent technique-related infections when this one is made at home.
This is a pragmatic, retrospective-prospective (ambispective) study of educational intervention for patients with stage V advanced chronic kidney disease and those with cardiorenal syndrome starting a peritoneal dialysis program.
A retrospective control group with patients starting PD before January 2020 will be included and compared with an intervention group that will systematically include all patients starting DP since the start of the study and they will be implemented a new educational intervention based on a systematic review that has been carried out with the most recent evidence.
- Conditions
- Peritoneal Infection
- Being tested
- Intervention to reduce infectious complications of peritoneal dialysis, Data collection from the patient's clinical history
- Keywords
- Educational intervention, Peritoneal dialysis, Peritonitis
- Medical subject headings
- Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention to reduce infectious complications of peritoneal dialysisBehavioural
Also called Prospective study group
- Before catheter placement: The nurse and doctor provide the patient and/or caregiver with a PD simulation.
- Initial training: from the placement of the catheter to the beginning of the technique at home, approximately 4 weeks, 6 and 7 sessions, duration 1-2 hours per session. Individualized learning taking into account learning abilities and education. It includes the explanation of the PD and the display of informational pictograms/capsules.
- Step-by-step teaching: peritoneal exchange, peritoneal orifice care, administration of intraperitoneal medication, recording of constants, detection of complications and risk behaviors.
- Nutritional education and water intake.
- Administration of the Objective Structured Assessment (OSA) checklist.
- Retraining: between the 1st and 3rd month of the start, after an episode of peritonitis and/or hospitalization, risk behaviors, functional/cognitive impairment, passivity/demotivation behaviors, and regularly once the year.
Data collection from the patient's clinical historyBehavioural
Also called Retrospective control group
Data collection from the patient's clinical history because this new standardized educational intervention was not used.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective control group | Other | This is the PD population sample from before January 2020. Receives: Behavioral: Data collection from the patient's clinical history |
| Prospective study group | Experimental | It will be the incident patients in PD who will receive the educational intervention contained in this project and whose results will be compared with the control group. Receives: Behavioral: Intervention to reduce infectious complications of peritoneal dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of peritonitis
It is calculated as the number of episodes of peritonitis per patient and year at risk.
Measured: 1 year after educational intervention.
Secondary outcomes (43)
Age
In years
Measured: Day 1 of peritoneal technique training.
Gender
Male or female
Measured: Day 1 of peritoneal technique training.
Language barrier
Yes or not
Measured: Day 1 of peritoneal technique training.
Marital status
Single, married, coupled, separated - divorced, widowed
Measured: Day 1 of peritoneal technique training.
Educational level
Not finished primary studies, primary schools, secondary, middle/higher grade cycle, high school, university studies, doctorate
Measured: Day 1 of peritoneal technique training.
Caregiver disposition
Yes or not
Measured: Day 1 of peritoneal technique training.
Drinking water supply
Yes or not
Measured: Day 1 of peritoneal technique training.
Weight
In kilograms
Measured: Day 1 of peritoneal technique training.
Height
In meters
Measured: Day 1 of peritoneal technique training.
Body Mass Index (BMI)
BMI= Current weight (kg) ÷ height (m) x height (m)= kg/m2. Low weight: Less than 18.4 Normal weight: 18.5 to 24.9 Overweight: 25 to 29.9 Grade I Obesity: 30 to 34.9 Grade II Obesity: 35 to 39.9 Grade III Obesity: Equal to or greater than 40.
Measured: Day 1 of peritoneal technique training.
Diabetes
Yes or not
Measured: Day 1 of peritoneal technique training.
Cardiovascular disease
Yes or not
Measured: Day 1 of peritoneal technique training.
Cerebrovascular disease
Yes or not
Measured: Day 1 of peritoneal technique training.
Hypertension
Yes or not
Measured: Day 1 of peritoneal technique training.
Cancer
Yes or not
Measured: Day 1 of peritoneal technique training.
The primary cause of kidney disease
Glomerular disease, tubulointerstitial disease, diabetes mellitus, hypertension, other systemic diseases, familial/hereditary nephropathy, various renal disorders
Measured: Day 1 of peritoneal technique training.
Barthel index
Scores of 100 imply total independence. Scores between 100 and 60 indicate the existence of a slight dependency or need for help, between 55 and 40 a moderate dependency, from 35 to 20 we would speak of severe dependency and scores below 20 points would indicate that the subject has a total dependence
Measured: Day 1 of peritoneal technique training.
Lawton and Brody scale
The 8 points indicate total independence to carry out the instrumental activities of daily life.- A lower result indicates functional deterioration.
Measured: Day 1 of peritoneal technique training.
Assessment of quality of life with the questionnaire EuroQol-5D (EQ-5D)
They are coded as 1 if the response option is "I have no problems"; with a 2 if the response option is "some or moderate problems"; and with a 3 if the answer option is "many problems." In such a way that the higher the value reflected, the worse the assessment that the subject makes of his or her state.
Measured: Day 1 of peritoneal technique training.
Cognitive impairment -PFEIFFER Test
From 0 to 2 errors: The patient is considered to have no cognitive impairment. 3 to 4 errors: The patient is considered to have mild cognitive impairment. From 5 to 7 errors: The patient is considered to have moderate cognitive impairment
Measured: Day 1 of peritoneal technique training.
Fragility detection - Q-Scale FRAIL
Between 1-2 affirmative answers: pre-fragile. >2 fragile
Measured: Day 1 of peritoneal technique training.
The origin before arriving at peritoneal dialysis
Pre-dialysis, hemodialysis, transplantation, cardiorenal syndrome
Measured: Day 1 of peritoneal technique training.
Residual renal function
Yes or not
Measured: Day 1 of peritoneal technique training.
Type of peritoneal catheter
Self-positioning catheter/Tenckhoff straight
Measured: Day 1 of peritoneal technique training.
Hemoglobin
12.0 - 16.0 gr/dl
Measured: First month of the start of the technique at home.
Serum albumin
3.4 - 5.2 g/dL
Measured: First month of the start of the technique at home.
Serum potassium
3.50 - 5.50 mmol/L
Measured: First month of the start of the technique at home.
Serum sodium
135.0 - 150.0 mmol/L
Measured: First month of the start of the technique at home.
Serum bicarbonate
23.0 - 27.0 mmol/L
Measured: First month of the start of the technique at home.
Serum calcium
8.80 - 10.60 mg/dL
Measured: First month of the start of the technique at home.
Serum phosphorus
2.70 - 4.50 mg/dL
Measured: First month of the start of the technique at home.
Blood urea nitrogen
10 - 50 mg/dL
Measured: First month of the start of the technique at home.
Serum creatinine
0.50 - 0.90 mg/dL
Measured: First month of the start of the technique at home.
Peritonitis
Yes or not
Measured: Follow-up during the first year after educational intervention.
Time to first peritonitis
In months without peritonitis
Measured: Follow-up during the first year after educational intervention.
Orifice infection
Yes or not
Measured: Follow-up during the first year after educational intervention.
Peritoneal orifice tunnelitis
Yes or not
Measured: Follow-up during the first year after educational intervention.
Result of peritoneal fluid culture
positive, negative
Measured: Follow-up during the first year after educational intervention.
Type of peritoneal infection
Germ, fungus, biofilm
Measured: Follow-up during the first year after educational intervention.
Reinfection
Yes or not
Measured: Follow-up during the first year after educational intervention.
Relapse
Yes or not
Measured: Follow-up during the first year after educational intervention.
Complicated peritonitis
change of technique/death
Measured: Follow-up during the first year after educational intervention.
Antibiotic administered
Type of antibiotic administered, the dosage.
Measured: Follow-up during the first year after educational intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start15 Sep 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peritoneal InfectionStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A retrospective control group with patients starting DP before January 2020 will be included and compared with an intervention group that will systematically include all patients starting DP since the start of the study.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat de Lleida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Fernandez Labadia, Universitat de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536673
- Sponsor's protocol ID
- CEIC-2900
- Status last verified
- Sep 2024
- First submitted
- 16 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bonnal H, Bechade C, Boyer A, Lobbedez T, Guillouet S, Verger C, Ficheux M, Lanot A. Effects of educational practices on the peritonitis risk in peritoneal dialysis: a retrospective cohort study with data from the French peritoneal Dialysis registry (RDPLF). BMC Nephrol. 2020 May 29;21(1):205. doi: 10.1186/s12882-020-01867-w.
PubMed 32471380Cho Y, Htay H, Johnson DW. Centre effects and peritoneal dialysis-related peritonitis. Nephrol Dial Transplant. 2017 Jun 1;32(6):913-915. doi: 10.1093/ndt/gfx054. No abstract available.
PubMed 28505351Gadola L, Poggi C, Poggio M, Saez L, Ferrari A, Romero J, Fumero S, Ghelfi G, Chifflet L, Borges PL. Using a multidisciplinary training program to reduce peritonitis in peritoneal dialysis patients. Perit Dial Int. 2013 Jan-Feb;33(1):38-45. doi: 10.3747/pdi.2011.00109. Epub 2012 Jul 1.
PubMed 22753455Bieber S, Mehrotra R. Peritoneal Dialysis Access Associated Infections. Adv Chronic Kidney Dis. 2019 Jan;26(1):23-29. doi: 10.1053/j.ackd.2018.09.002.
PubMed 30876613
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Intervention Aimed At Reducing Infectious Complications Related to Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT06536673
- Acronym / sponsor ID
- CEIC-2900
- Conditions
- Peritoneal Infection
- Keywords
- Educational intervention, Peritoneal dialysis, Peritonitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universitat de LleidaUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 5 Aug 2024 (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.
Peritonitis is a common and serious complication of peritoneal dialysis (PD) and is one of the main causes of peritoneal dialysis technique failure and long-term hemodialysis conversion.
Detailed description
Peritoneal infections (PI) have been a very relevant representative of peritoneal dialysis (PD) for decades. PI is a very serious complication of PD and is a source of concern because of its high incidence. Each episode carries clinical consequences for the patient, increases in treatment costs, hospital admissions, technical failures and risk of death, especially in the 30 days following an episode.
The risk of peritonitis depends on non-modifiable factors (such as age, sex, diabetes) and modifiable factors (such as anti-infective prophylaxis, catheter care, and training).
It is important to accurately analyze the effect of modifiable factors, as they are the most relevant in reducing the rate of peritonitis.
Patient education is very important and can affect the success of the technique and clinical results. Therapeutic education has been considered a key factor in PD outcomes.
The PD nurse is responsible for training the patient and/or caregiver to be self-sufficient and autonomous in care, reinforce and highlight the importance of adherence to treatment, and promote safe actions to prevent technique-related infections when this one is made at home.
This is a pragmatic, retrospective-prospective (ambispective) study of educational intervention for patients with stage V advanced chronic kidney disease and those with cardiorenal syndrome starting a peritoneal dialysis program.
A retrospective control group with patients starting PD before January 2020 will be included and compared with an intervention group that will systematically include all patients starting DP since the start of the study and they will be implemented a new educational intervention based on a systematic review that has been carried out with the most recent evidence.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A retrospective control group with patients starting DP before January 2020 will be included and compared with an intervention group that will systematically include all patients starting DP since the start of the study.
| Arm | Type | Receives |
|---|---|---|
| Retrospective control group | Other | Behavioral: Data collection from the patient's clinical historyThis is the PD population sample from before January 2020. |
| Prospective study group | Experimental | Behavioral: Intervention to reduce infectious complications of peritoneal dialysisIt will be the incident patients in PD who will receive the educational intervention contained in this project and whose results will be compared with the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients >18 years of age
- Medically stable
- Who can perform dialysis themselves or with the help of a caregiver willing to participate in the study and sign the informed consent will be included
Key exclusion criteria (3 listed)
- Patients with psychiatric, psychological disorders and social (language barrier included)
- Who do not have a formal/informal caregiver
- Those who due to medical needs cannot continue with the standard schedule, pregnant women, participants who suffered peritonitis before receiving the educational intervention
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 |
|---|---|---|
| Intervention to reduce infectious complications of peritoneal dialysisAlso: Prospective study group* Before catheter placement: The nurse and doctor provide the patient and/or caregiver with a PD simulation. * Initial training: from the placement of the catheter to the beginning of the technique at home, approximately 4 weeks, 6 and 7 sessions, duration 1-2 hours per session. Individualized learning taking into account learning abilities and education. It includes the explanation of the PD and the display of informational pictograms/capsules. * Step-by-step teaching: peritoneal exchange, peritoneal orifice care, administration of intraperitoneal medication, recording of constants, detection of complications and risk behaviors. * Nutritional education and water intake. * Administration of the Objective Structured Assessment (OSA) checklist. * Retraining: between the 1st and 3rd month of the start, after an episode of peritonitis and/or hospitalization, risk behaviors, functional/cognitive impairment, passivity/demotivation behaviors, and regularly once the year. | Behavioural | Prospective study group |
| Data collection from the patient's clinical historyAlso: Retrospective control groupData collection from the patient's clinical history because this new standardized educational intervention was not used. | Behavioural | Retrospective control group |
Primary outcome
Rate of peritonitis
Time frame: 1 year after educational intervention.
It is calculated as the number of episodes of peritonitis per patient and year at risk.
43 secondary outcomes
Age
Time frame: Day 1 of peritoneal technique training.
Gender
Time frame: Day 1 of peritoneal technique training.
Language barrier
Time frame: Day 1 of peritoneal technique training.
Marital status
Time frame: Day 1 of peritoneal technique training.
Educational level
Time frame: Day 1 of peritoneal technique training.
Caregiver disposition
Time frame: Day 1 of peritoneal technique training.
Drinking water supply
Time frame: Day 1 of peritoneal technique training.
Weight
Time frame: Day 1 of peritoneal technique training.
Height
Time frame: Day 1 of peritoneal technique training.
Body Mass Index (BMI)
Time frame: Day 1 of peritoneal technique training.
Diabetes
Time frame: Day 1 of peritoneal technique training.
Cardiovascular disease
Time frame: Day 1 of peritoneal technique training.
Cerebrovascular disease
Time frame: Day 1 of peritoneal technique training.
Hypertension
Time frame: Day 1 of peritoneal technique training.
Cancer
Time frame: Day 1 of peritoneal technique training.
The primary cause of kidney disease
Time frame: Day 1 of peritoneal technique training.
Barthel index
Time frame: Day 1 of peritoneal technique training.
Lawton and Brody scale
Time frame: Day 1 of peritoneal technique training.
Assessment of quality of life with the questionnaire EuroQol-5D (EQ-5D)
Time frame: Day 1 of peritoneal technique training.
Cognitive impairment -PFEIFFER Test
Time frame: Day 1 of peritoneal technique training.
Fragility detection - Q-Scale FRAIL
Time frame: Day 1 of peritoneal technique training.
The origin before arriving at peritoneal dialysis
Time frame: Day 1 of peritoneal technique training.
Residual renal function
Time frame: Day 1 of peritoneal technique training.
Type of peritoneal catheter
Time frame: Day 1 of peritoneal technique training.
Hemoglobin
Time frame: First month of the start of the technique at home.
Serum albumin
Time frame: First month of the start of the technique at home.
Serum potassium
Time frame: First month of the start of the technique at home.
Serum sodium
Time frame: First month of the start of the technique at home.
Serum bicarbonate
Time frame: First month of the start of the technique at home.
Serum calcium
Time frame: First month of the start of the technique at home.
Serum phosphorus
Time frame: First month of the start of the technique at home.
Blood urea nitrogen
Time frame: First month of the start of the technique at home.
Serum creatinine
Time frame: First month of the start of the technique at home.
Peritonitis
Time frame: Follow-up during the first year after educational intervention.
Time to first peritonitis
Time frame: Follow-up during the first year after educational intervention.
Orifice infection
Time frame: Follow-up during the first year after educational intervention.
Peritoneal orifice tunnelitis
Time frame: Follow-up during the first year after educational intervention.
Result of peritoneal fluid culture
Time frame: Follow-up during the first year after educational intervention.
Type of peritoneal infection
Time frame: Follow-up during the first year after educational intervention.
Reinfection
Time frame: Follow-up during the first year after educational intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 32471380Bonnal H, Bechade C, Boyer A, Lobbedez T, Guillouet S, Verger C, Ficheux M, Lanot A. Effects of educational practices on the peritonitis risk in peritoneal dialysis: a retrospective cohort study with data from the French peritoneal Dialysis registry (RDPLF). BMC Nephrol. 2020 May 29;21(1):205. doi: 10.1186/s12882-020-01867-w.
- Background: PubMed 28505351Cho Y, Htay H, Johnson DW. Centre effects and peritoneal dialysis-related peritonitis. Nephrol Dial Transplant. 2017 Jun 1;32(6):913-915. doi: 10.1093/ndt/gfx054. No abstract available.
- Background: PubMed 22753455Gadola L, Poggi C, Poggio M, Saez L, Ferrari A, Romero J, Fumero S, Ghelfi G, Chifflet L, Borges PL. Using a multidisciplinary training program to reduce peritonitis in peritoneal dialysis patients. Perit Dial Int. 2013 Jan-Feb;33(1):38-45. doi: 10.3747/pdi.2011.00109. Epub 2012 Jul 1.
- Background: PubMed 30876613Bieber S, Mehrotra R. Peritoneal Dialysis Access Associated Infections. Adv Chronic Kidney Dis. 2019 Jan;26(1):23-29. doi: 10.1053/j.ackd.2018.09.002.
- Clinical guide of the Spanish Society of Nephrology on the prevention and treatment of peritoneal infection in peritoneal dialysisLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention to reduce infectious complications of peritoneal dialysis and Data collection from the patient's clinical history in people with Peritoneal Infection, run by Universitat de Lleida.
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 3 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Elena Fernàndez Labadía, PhD student (+34626-321-345, elena.fernandez@udl.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of peritonitis (time frame: 1 year after educational intervention.). 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 NCT06536673, which also lists 4 linked publications.
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 19 Sep 2024.