Intervention to Reduce Infectious Complications of Peritoneal Dialysis

Official title

Educational Intervention Aimed At Reducing Infectious Complications Related to Peritoneal Dialysis

Overview

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.

Interventions

• Behavioral 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, peri
• 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.

Primary outcome measures

• Rate of peritonitis [Time frame: 1 year after educational intervention.]

Secondary outcome measures (12)

• 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.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 32471380
• 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
• 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
• 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

Identifiers

NCT: NCT06536673 · CEIC-2900

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗