Intervention to Reduce Infectious Complications of Peritoneal Dialysis
NCT Number: NCT06536673
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Peritoneal Infection
Interventions: BEHAVIORAL: Intervention to reduce infectious complications of peritoneal dialysis|BEHAVIORAL: Data collection from the patient's clinical history
Sponsor: Universitat de Lleida
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2025-09-01

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.

Primary Outcome Measures: 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: 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.