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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000660482

Acronym

ReHeMon

Enrollment

Registered

2016-05-20

Start date

2016-04-01

Completion date

2016-12-15

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Intradialytic hypotension (IH) is common complication in patients with stage 5 chronic kidney disease (CKD5) on hemodialysis. Its incidence ranges from 15 to 30%. Levocarnitine (LC) has been used as a part of treatment in these kind of patients. LC is a quaternary amine involved in intermediary energetic metabolism, and is also essential in transferring long chain fatty acids through mitochondrial membranes. Those with CKD have relative deficiency of LC. A single-center, prospective, randomized, placebo-controlled quadruple-blinded trial was designed to demonstrate the efficiency of LC in the prevention of IH in patients with CKD5. The subjects will be chosen by convenience sampling. They will be further divided into 4 groups (group 1 [gLC0]: LC [30 mg/kg] at 0 min before starting hemodialysis session; group 2 [gLC30]: LC [30 mg/kg] at 30 min before starting the hemodialysis session; group 3[gP0]: normal saline [5 mL/kg] at 0 min before starting hemodialysis session; group 4 [gP30]: normal saline [5 mL/kg] at 30 min before starting hemodialysis session). The intervention will last 12 weeks.

Interventions

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..

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Healthy volunteers

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.

Exclusion criteria

Patients who have been treated with levocarnitine in the previous 6 months; patients who have had septic shock in the previous 6 months; pregnancy; lactation; and a history of hypersensitivity or contraindication to levocarnitine.

Outcome results