Intervention to Reduce Infectious Complications of Peritoneal Dialysis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peritoneal Infection
• Intervention / Treatment: Behavioral: Data collection from the patient's clinical history; Behavioral: Intervention to reduce infectious complications of peritoneal dialysis

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Retrospective control group; This is the PD population sample from before January 2020.	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.; Other Names: Retrospective control group
Experimental: 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.	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, 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.; Other Names: Prospective study group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	In years	Day 1 of peritoneal technique training.
Gender	Male or female	Day 1 of peritoneal technique training.
Language barrier	Yes or not	Day 1 of peritoneal technique training.
Marital status	Single, married, coupled, separated - divorced, widowed	Day 1 of peritoneal technique training.
Educational level	Not finished primary studies, primary schools, secondary, middle/higher grade cycle, high school, university studies, doctorate	Day 1 of peritoneal technique training.
Caregiver disposition	Yes or not	Day 1 of peritoneal technique training.
Drinking water supply	Yes or not	Day 1 of peritoneal technique training.
Weight	In kilograms	Day 1 of peritoneal technique training.
Height	In meters	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.	Day 1 of peritoneal technique training.
Diabetes	Yes or not	Day 1 of peritoneal technique training.
Cardiovascular disease	Yes or not	Day 1 of peritoneal technique training.
Cerebrovascular disease	Yes or not	Day 1 of peritoneal technique training.
Hypertension	Yes or not	Day 1 of peritoneal technique training.
Cancer	Yes or not	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	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	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.	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.	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	Day 1 of peritoneal technique training.
Fragility detection - Q-Scale FRAIL	Between 1-2 affirmative answers: pre-fragile. >2 fragile	Day 1 of peritoneal technique training.
The origin before arriving at peritoneal dialysis	Pre-dialysis, hemodialysis, transplantation, cardiorenal syndrome	Day 1 of peritoneal technique training.
Residual renal function	Yes or not	Day 1 of peritoneal technique training.
Type of peritoneal catheter	Self-positioning catheter/Tenckhoff straight	Day 1 of peritoneal technique training.
Hemoglobin	12.0 - 16.0 gr/dl	First month of the start of the technique at home.
Serum albumin	3.4 - 5.2 g/dL	First month of the start of the technique at home.
Serum potassium	3.50 - 5.50 mmol/L	First month of the start of the technique at home.
Serum sodium	135.0 - 150.0 mmol/L	First month of the start of the technique at home.
Serum bicarbonate	23.0 - 27.0 mmol/L	First month of the start of the technique at home.
Serum calcium	8.80 - 10.60 mg/dL	First month of the start of the technique at home.
Serum phosphorus	2.70 - 4.50 mg/dL	First month of the start of the technique at home.
Blood urea nitrogen	10 - 50 mg/dL	First month of the start of the technique at home.
Serum creatinine	0.50 - 0.90 mg/dL	First month of the start of the technique at home.
Peritonitis	Yes or not	Follow-up during the first year after educational intervention.
Time to first peritonitis	In months without peritonitis	Follow-up during the first year after educational intervention.
Orifice infection	Yes or not	Follow-up during the first year after educational intervention.
Peritoneal orifice tunnelitis	Yes or not	Follow-up during the first year after educational intervention.
Result of peritoneal fluid culture	positive, negative	Follow-up during the first year after educational intervention.
Type of peritoneal infection	Germ, fungus, biofilm	Follow-up during the first year after educational intervention.
Reinfection	Yes or not	Follow-up during the first year after educational intervention.
Relapse	Yes or not	Follow-up during the first year after educational intervention.
Complicated peritonitis	change of technique/death	Follow-up during the first year after educational intervention.
Antibiotic administered	Type of antibiotic administered, the dosage.	Follow-up during the first year after educational intervention.

Collaborators and Investigators

• Sponsor: Universitat de Lleida

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 5, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Peritoneal dialysis; Educational intervention; Peritonitis
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: CEIC-2900

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No