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NCT Number: NCT06536673

Intervention to Reduce Infectious Complications of 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.

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Key information

Conditions

Peritoneal Infection Digestive System Diseases Infections Intraabdominal Infections Peritoneal Diseases Peritonitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Other names: Retrospective control group

Primary outcomes

  1. Rate of peritonitis

    Time frame: 1 year after educational intervention.

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

Secondary outcomes

  1. Age

    Time frame: Day 1 of peritoneal technique training.

    In years

  2. Gender

    Time frame: Day 1 of peritoneal technique training.

    Male or female

  3. Language barrier

    Time frame: Day 1 of peritoneal technique training.

    Yes or not

  4. Marital status

    Time frame: Day 1 of peritoneal technique training.

    Single, married, coupled, separated - divorced, widowed

  5. Educational level

    Time frame: Day 1 of peritoneal technique training.

    Not finished primary studies, primary schools, secondary, middle/higher grade cycle, high school, university studies, doctorate

  6. Caregiver disposition

    Time frame: Day 1 of peritoneal technique training.

    Yes or not

  7. Drinking water supply

    Time frame: Day 1 of peritoneal technique training.

    Yes or not

  8. Weight

    Time frame: Day 1 of peritoneal technique training.

    In kilograms

  9. Height

    Time frame: Day 1 of peritoneal technique training.

    In meters

  10. Body Mass Index (BMI)

    Time frame: Day 1 of peritoneal technique training.

    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.

  11. Diabetes

    Time frame: Day 1 of peritoneal technique training.

    Yes or not

  12. Cardiovascular disease

    Time frame: Day 1 of peritoneal technique training.

    Yes or not

  13. Cerebrovascular disease

    Time frame: Day 1 of peritoneal technique training.

    Yes or not

  14. Hypertension

    Time frame: Day 1 of peritoneal technique training.

    Yes or not

  15. Cancer

    Time frame: Day 1 of peritoneal technique training.

    Yes or not

  16. The primary cause of kidney disease

    Time frame: Day 1 of peritoneal technique training.

    Glomerular disease, tubulointerstitial disease, diabetes mellitus, hypertension, other systemic diseases, familial/hereditary nephropathy, various renal disorders

  17. Barthel index

    Time frame: Day 1 of peritoneal technique training.

    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

  18. Lawton and Brody scale

    Time frame: Day 1 of peritoneal technique training.

    The 8 points indicate total independence to carry out the instrumental activities of daily life.- A lower result indicates functional deterioration.

  19. Assessment of quality of life with the questionnaire EuroQol-5D (EQ-5D)

    Time frame: Day 1 of peritoneal technique training.

    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.

  20. Cognitive impairment -PFEIFFER Test

    Time frame: Day 1 of peritoneal technique training.

    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

  21. Fragility detection - Q-Scale FRAIL

    Time frame: Day 1 of peritoneal technique training.

    Between 1-2 affirmative answers: pre-fragile. >2 fragile

  22. The origin before arriving at peritoneal dialysis

    Time frame: Day 1 of peritoneal technique training.

    Pre-dialysis, hemodialysis, transplantation, cardiorenal syndrome

  23. Residual renal function

    Time frame: Day 1 of peritoneal technique training.

    Yes or not

  24. Type of peritoneal catheter

    Time frame: Day 1 of peritoneal technique training.

    Self-positioning catheter/Tenckhoff straight

  25. Hemoglobin

    Time frame: First month of the start of the technique at home.

    12.0 - 16.0 gr/dl

  26. Serum albumin

    Time frame: First month of the start of the technique at home.

    3.4 - 5.2 g/dL

  27. Serum potassium

    Time frame: First month of the start of the technique at home.

    3.50 - 5.50 mmol/L

  28. Serum sodium

    Time frame: First month of the start of the technique at home.

    135.0 - 150.0 mmol/L

  29. Serum bicarbonate

    Time frame: First month of the start of the technique at home.

    23.0 - 27.0 mmol/L

  30. Serum calcium

    Time frame: First month of the start of the technique at home.

    8.80 - 10.60 mg/dL

  31. Serum phosphorus

    Time frame: First month of the start of the technique at home.

    2.70 - 4.50 mg/dL

  32. Blood urea nitrogen

    Time frame: First month of the start of the technique at home.

    10 - 50 mg/dL

  33. Serum creatinine

    Time frame: First month of the start of the technique at home.

    0.50 - 0.90 mg/dL

  34. Peritonitis

    Time frame: Follow-up during the first year after educational intervention.

    Yes or not

  35. Time to first peritonitis

    Time frame: Follow-up during the first year after educational intervention.

    In months without peritonitis

  36. Orifice infection

    Time frame: Follow-up during the first year after educational intervention.

    Yes or not

  37. Peritoneal orifice tunnelitis

    Time frame: Follow-up during the first year after educational intervention.

    Yes or not

  38. Result of peritoneal fluid culture

    Time frame: Follow-up during the first year after educational intervention.

    positive, negative

  39. Type of peritoneal infection

    Time frame: Follow-up during the first year after educational intervention.

    Germ, fungus, biofilm

  40. Reinfection

    Time frame: Follow-up during the first year after educational intervention.

    Yes or not

  41. Relapse

    Time frame: Follow-up during the first year after educational intervention.

    Yes or not

  42. Complicated peritonitis

    Time frame: Follow-up during the first year after educational intervention.

    change of technique/death

  43. Antibiotic administered

    Time frame: Follow-up during the first year after educational intervention.

    Type of antibiotic administered, the dosage.

Study contacts

Contact information is provided by the study sponsor or research team.

Elena Fernàndez Labadía, PhD student

CONTACT

[email protected]

+34626-321-345

Sponsors and collaborators

Lead sponsor

Universitat de Lleida

Other

Registry information

Official study title

Educational Intervention Aimed At Reducing Infectious Complications Related to Peritoneal Dialysis

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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