Clinical trial NCT06536673: Intervention to Reduce Infectious Complications of Peritoneal Dialysis
Official title: Educational Intervention Aimed At Reducing Infectious Complications Related to Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peritoneal Infection
Keywords: Educational intervention
Peritoneal dialysis
Peritonitis
Lead sponsor: Universitat de Lleida
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Rate of peritonitis
timeFrame: 1 year after educational intervention.
Secondary outcomes:
measure: Age
timeFrame: Day 1 of peritoneal technique training.
measure: Gender
timeFrame: Day 1 of peritoneal technique training.
measure: Language barrier
timeFrame: Day 1 of peritoneal technique training.
measure: Marital status
timeFrame: Day 1 of peritoneal technique training.
measure: Educational level
timeFrame: Day 1 of peritoneal technique training.
measure: Caregiver disposition
timeFrame: Day 1 of peritoneal technique training.
measure: Drinking water supply
timeFrame: Day 1 of peritoneal technique training.
measure: Weight
timeFrame: Day 1 of peritoneal technique training.
measure: Height
timeFrame: Day 1 of peritoneal technique training.
measure: Body Mass Index (BMI)
timeFrame: Day 1 of peritoneal technique training.
measure: Diabetes
timeFrame: Day 1 of peritoneal technique training.
measure: Cardiovascular disease
timeFrame: Day 1 of peritoneal technique training.
measure: Cerebrovascular disease
timeFrame: Day 1 of peritoneal technique training.
measure: Hypertension
timeFrame: Day 1 of peritoneal technique training.
measure: Cancer
timeFrame: Day 1 of peritoneal technique training.
measure: The primary cause of kidney disease
timeFrame: Day 1 of peritoneal technique training.
measure: Barthel index
timeFrame: Day 1 of peritoneal technique training.
measure: Lawton and Brody scale
timeFrame: Day 1 of peritoneal technique training.
measure: Assessment of quality of life with the questionnaire EuroQol-5D (EQ-5D)
timeFrame: Day 1 of peritoneal technique training.
measure: Cognitive impairment -PFEIFFER Test
timeFrame: Day 1 of peritoneal technique training.
measure: Fragility detection - Q-Scale FRAIL
timeFrame: Day 1 of peritoneal technique training.
measure: The origin before arriving at peritoneal dialysis
timeFrame: Day 1 of peritoneal technique training.
measure: Residual renal function
timeFrame: Day 1 of peritoneal technique training.
measure: Type of peritoneal catheter
timeFrame: Day 1 of peritoneal technique training.
measure: Hemoglobin
timeFrame: First month of the start of the technique at home.
measure: Serum albumin
timeFrame: First month of the start of the technique at home.
measure: Serum potassium
timeFrame: First month of the start of the technique at home.
measure: Serum sodium
timeFrame: First month of the start of the technique at home.
measure: Serum bicarbonate
timeFrame: First month of the start of the technique at home.
measure: Serum calcium
timeFrame: First month of the start of the technique at home.
measure: Serum phosphorus
timeFrame: First month of the start of the technique at home.
measure: Blood urea nitrogen
timeFrame: First month of the start of the technique at home.
measure: Serum creatinine
timeFrame: First month of the start of the technique at home.
measure: Peritonitis
timeFrame: Follow-up during the first year after educational intervention.
measure: Time to first peritonitis
timeFrame: Follow-up during the first year after educational intervention.
measure: Orifice infection
timeFrame: Follow-up during the first year after educational intervention.
measure: Peritoneal orifice tunnelitis
timeFrame: Follow-up during the first year after educational intervention.
measure: Result of peritoneal fluid culture
timeFrame: Follow-up during the first year after educational intervention.
measure: Type of peritoneal infection
timeFrame: Follow-up during the first year after educational intervention.
measure: Reinfection
timeFrame: Follow-up during the first year after educational intervention.
measure: Relapse
timeFrame: Follow-up during the first year after educational intervention.
measure: Complicated peritonitis
timeFrame: Follow-up during the first year after educational intervention.
measure: Antibiotic administered
timeFrame: Follow-up during the first year after educational intervention.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.