Intervention to Reduce Infectious Complications of Peritoneal Dialysis
- Conditions
- Peritoneal Infection
- Interventions
- Behavioral: Data collection from the patient's clinical historyBehavioral: Intervention to reduce infectious complications of peritoneal dialysis
- Registration Number
- NCT06536673
- Lead Sponsor
- Universitat de Lleida
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Retrospective control group Data collection from the patient's clinical history This is the PD population sample from before January 2020. Prospective study group Intervention to reduce infectious complications of peritoneal dialysis 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.
- Primary Outcome Measures
Name Time Method Rate of peritonitis 1 year after educational intervention. It is calculated as the number of episodes of peritonitis per patient and year at risk.
- Secondary Outcome Measures
Name Time Method Weight Day 1 of peritoneal technique training. In kilograms
Hypertension Day 1 of peritoneal technique training. Yes or not
Residual renal function Day 1 of peritoneal technique training. Yes or not
Type of peritoneal catheter Day 1 of peritoneal technique training. Self-positioning catheter/Tenckhoff straight
Serum calcium First month of the start of the technique at home. 8.80 - 10.60 mg/dL
Gender Day 1 of peritoneal technique training. Male or female
Hemoglobin First month of the start of the technique at home. 12.0 - 16.0 gr/dl
Language barrier Day 1 of peritoneal technique training. Yes or not
Assessment of quality of life with the questionnaire EuroQol-5D (EQ-5D) 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.
Cognitive impairment -PFEIFFER Test 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
The origin before arriving at peritoneal dialysis Day 1 of peritoneal technique training. Pre-dialysis, hemodialysis, transplantation, cardiorenal syndrome
Age Day 1 of peritoneal technique training. In years
Marital status Day 1 of peritoneal technique training. Single, married, coupled, separated - divorced, widowed
Educational level Day 1 of peritoneal technique training. Not finished primary studies, primary schools, secondary, middle/higher grade cycle, high school, university studies, doctorate
Height Day 1 of peritoneal technique training. In meters
Diabetes Day 1 of peritoneal technique training. Yes or not
Cerebrovascular disease Day 1 of peritoneal technique training. Yes or not
Barthel index 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
Lawton and Brody scale 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.
Body Mass Index (BMI) 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.
Cardiovascular disease Day 1 of peritoneal technique training. Yes or not
Cancer Day 1 of peritoneal technique training. Yes or not
The primary cause of kidney disease Day 1 of peritoneal technique training. Glomerular disease, tubulointerstitial disease, diabetes mellitus, hypertension, other systemic diseases, familial/hereditary nephropathy, various renal disorders
Caregiver disposition Day 1 of peritoneal technique training. Yes or not
Relapse Follow-up during the first year after educational intervention. Yes or not
Drinking water supply Day 1 of peritoneal technique training. Yes or not
Fragility detection - Q-Scale FRAIL Day 1 of peritoneal technique training. Between 1-2 affirmative answers: pre-fragile. \>2 fragile
Serum phosphorus First month of the start of the technique at home. 2.70 - 4.50 mg/dL
Peritonitis Follow-up during the first year after educational intervention. Yes or not
Time to first peritonitis Follow-up during the first year after educational intervention. In months without peritonitis
Antibiotic administered Follow-up during the first year after educational intervention. Type of antibiotic administered, the dosage.
Serum potassium First month of the start of the technique at home. 3.50 - 5.50 mmol/L
Serum sodium First month of the start of the technique at home. 135.0 - 150.0 mmol/L
Serum bicarbonate First month of the start of the technique at home. 23.0 - 27.0 mmol/L
Blood urea nitrogen First month of the start of the technique at home. 10 - 50 mg/dL
Reinfection Follow-up during the first year after educational intervention. Yes or not
Complicated peritonitis Follow-up during the first year after educational intervention. change of technique/death
Serum albumin First month of the start of the technique at home. 3.4 - 5.2 g/dL
Orifice infection Follow-up during the first year after educational intervention. Yes or not
Peritoneal orifice tunnelitis Follow-up during the first year after educational intervention. Yes or not
Type of peritoneal infection Follow-up during the first year after educational intervention. Germ, fungus, biofilm
Serum creatinine First month of the start of the technique at home. 0.50 - 0.90 mg/dL
Result of peritoneal fluid culture Follow-up during the first year after educational intervention. positive, negative