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Intervention to Reduce Infectious Complications of Peritoneal Dialysis

U

Universitat de Lleida

Status

Not yet enrolling

Conditions

Peritoneal Infection

Treatments

Behavioral: Intervention to reduce infectious complications of peritoneal dialysis
Behavioral: Data collection from the patient's clinical history

Study type

Interventional

Funder types

Other

Identifiers

NCT06536673
CEIC-2900

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Retrospective control group
Other group
Description:
This is the PD population sample from before January 2020.
Treatment:
Behavioral: Data collection from the patient's clinical history
Prospective study group
Experimental group
Description:
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.
Treatment:
Behavioral: Intervention to reduce infectious complications of peritoneal dialysis

Trial contacts and locations

0

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Central trial contact

Elena Fernàndez Labadía, PhD student

Data sourced from clinicaltrials.gov

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