Intervention to Reduce Infectious Complications of Peritoneal Dialysis

NCT ID: NCT06536673

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-15
• Study Completion Date: 2025-09-01

Brief 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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Retrospective control group

This is the PD population sample from before January 2020.

Group Type: OTHER

Data collection from the patient's clinical history

Intervention Type: BEHAVIORAL

Data collection from the patient's clinical history because this new standardized educational intervention was not used.

Prospective study group

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.

Group Type: EXPERIMENTAL

Intervention to reduce infectious complications of peritoneal dialysis

Intervention Type: BEHAVIORAL

• 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.

Interventions

Intervention to reduce infectious complications of peritoneal dialysis

• 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.

Intervention Type: BEHAVIORAL

Data collection from the patient's clinical history

Data collection from the patient's clinical history because this new standardized educational intervention was not used.

Intervention Type: BEHAVIORAL

Other Intervention Names

Prospective study group; Retrospective control group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat de Lleida

OTHER

Sponsor Role: lead

Responsible Party

Elena Fernandez Labadia

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Elena Fernàndez Labadía, PhD student

Role: CONTACT

elena.fernandez@udl.cat

+34626-321-345

References

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.

Reference Type: BACKGROUND

PMID: 32471380 (View on PubMed)

Cho 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.

Reference Type: BACKGROUND

PMID: 28505351 (View on PubMed)

Gadola 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.

Reference Type: BACKGROUND

PMID: 22753455 (View on PubMed)

Bieber 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.

Reference Type: BACKGROUND

PMID: 30876613 (View on PubMed)

Related Links

https://doi.org/10.1016/J.NEFRO.2021.10.007

Clinical guide of the Spanish Society of Nephrology on the prevention and treatment of peritoneal infection in peritoneal dialysis

Other Identifiers

CEIC-2900

Identifier Type: -

Identifier Source: org_study_id