Intervention to Reduce Infectious Complications of Peritoneal Dialysis

NCT06536673 | Not Yet Recruiting

• 1 other identifier: CEIC-2900
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peritoneal Infection

Keywords

Educational intervention; Peritoneal dialysis; Peritonitis

Outcome Measures

Primary Outcomes (1)

• Rate of peritonitis

  It is calculated as the number of episodes of peritonitis per patient and year at risk.

  1 year after educational intervention.

Secondary Outcomes (43)

• Age

  Day 1 of peritoneal technique training.

• Gender

  Day 1 of peritoneal technique training.

• Language barrier

  Day 1 of peritoneal technique training.

• Marital status

  Day 1 of peritoneal technique training.

• Educational level

  Day 1 of peritoneal technique training.

Study Arms (2)

Retrospective control group

OTHER

This is the PD population sample from before January 2020.

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.

Behavioral: Intervention to reduce infectious complications of peritoneal dialysis

Interventions

Intervention to reduce infectious complications of peritoneal dialysis 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.

Also known as: Prospective study group

Prospective study group

Data collection from the patient's clinical history BEHAVIORAL

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

Also known as: Retrospective control group

Retrospective control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat de Lleida: lead

Related Publications (4)

• 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.

  PMID: 32471380 BACKGROUND

• 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.

  PMID: 28505351 BACKGROUND

• 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.

  PMID: 22753455 BACKGROUND

• 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.

  PMID: 30876613 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Peritonitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Central Study Contacts

Elena Fernàndez Labadía, PhD student

CONTACT

+34626-321-345; elena.fernandez@udl.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: August 5, 2024
• Study Start: September 15, 2024
• Primary Completion: February 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09