Levocarnitine as primary prophylaxis for intradialytic hypotension in patients with stage 5 chronic kidney disease

INTERVENTION: The authors will be responsible for administering the drug: levocarnitine (LC) or placebo. Patients will be selected and then randomized in the hemodialysis unit of the University Hospital of the Autonomous University of Nuevo Leon in Monterrey, Mexico. The following clinical intervention will take place: randomized patients will be included in the study, They will be divided into 4 groups: Group LC0 (gLC0) ‐ LC will be administered at a dose of 30 mg/kg/session (2 sessions/week) for a period of 12 weeks. LC will be administered at 0 minutes before the start of the hemodialysis session. Group LC30 (gLC30) ‐ LC will be administered at a dose of 30 mg/kg/session (2 sessions/week) for a period of 12 weeks. LC will be administered at 30 minutes before the start of the hemodialysis session. Group P0 (gP0) ‐ Placebo (normal saline, 5 ml/session, 2 sessions/week) will be administered for a period of 12 weeks. Placebo will be administered at 0 minutes before the start of the hemodialysis session. Group P30 (gP30) ‐ Placebo (normal saline, 5 ml/session, 2 sessions/week) will be administered for a period of 12 weeks. Placebo will be administered at at 30 minutes before the start of the hemodialysis session. The drug administration will be made as follows: Patients assigned to the gLC0 will received LC (30 mg/kg/session ) as an slow intravenous bolus (2‐3 minutes) through the venous catheter line, 0 minutes before each session of hemodialysis for 12 weeks. Patients assigned to gLC30 will received LC (30 mg/kg/session ) as an slow intravenous bolus (2‐3 minutes) through the venous catheter line, 30 minutes before each session of hemodialysis for 12 weeks. The product that will be used is levocarnitine (Efe‐Carn, PISA, Mexico), injectable vial whose content is 1 g/5 mL.. CONDITION: chronic kidney disease chronic renal disease hemodialysis PRIMARY OUTCOME: Number of episodes of intradialytic hypotension in patients with stage 5 chronic kidney disease. ; Every 30 minutes, blood pressure of every patient enrolled will be assessed using a conventional sphygmomanometry and the data will be registered in mm Hg. SECONDARY OUTCOME: Percentage of episodes of intradialytic hypotension in patients with stage 5 chronic kidney disease. ; Every 30 minutes, blood pressure of every patient enrolled will be assessed using a conventional sphygmomanometry and the data will be registered in mm Hg. Quality of life measured by SF 12, SF 16, COOP/WONCA questionaries in patients with stage 5 chronic kidney disease INCLUSION CRITERIA: Clinically stable patients; men and nonpregnant women, not breastfeeding; aged 18 to 85 years; regular attendance hemodialysis sessions at least twice a week; a minimum of 6 months on hemodialysis; and who had 2 or more episodes of intradialytic hypotension in the past 6 months.