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Trial registered on ANZCTR


Registration number
ACTRN12616000660482
Ethics application status
Approved
Date submitted
14/04/2016
Date registered
20/05/2016
Date last updated
19/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Levocarnitine as primary prophylaxis for intradialytic hypotension in patients with stage 5 chronic kidney disease
Scientific title
Levocarnitine as primary prophylaxis for intradialytic hypotension in patients with stage 5 chronic kidney disease
Secondary ID [1] 288979 0
None
Universal Trial Number (UTN)
U1111-1181-8467
Trial acronym
ReHeMon
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic renal disease 298372 0
chronic kidney disease 298373 0
hemodialysis 298374 0
Condition category
Condition code
Renal and Urogenital 298477 298477 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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..
Intervention code [1] 294465 0
Treatment: Drugs
Intervention code [2] 294694 0
Prevention
Comparator / control treatment
Patients assigned to the gP0 will received normal saline (5 ml/session, 2 sessions/week) 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 the gP30 will received normal saline (5 ml/session, 2 sessions/week) as an slow intravenous bolus (2-3 minutes) through the venous catheter line, 30 minutes before each session of hemodialysis for 12 weeks.

We will use normal saline (PISA, Mexico) as placebo, this product is an injectable vial whose content is 0.9 g / 100 mL.
Control group
Placebo

Outcomes
Primary outcome [1] 297969 0
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.
Timepoint [1] 297969 0
12 weeks post commencement of intervention/placebo.
In every hemodialysis session blood pressure of every patient enrolled will be assessed using a conventional sphygmomanometry and the data will be registered in mm Hg, every 30 minutes,
Secondary outcome [1] 322800 0
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.
Timepoint [1] 322800 0
12 weeks post commencement of intervention/placebo.
In every hemodialysis session blood pressure of every patient enrolled will be assessed using a conventional sphygmomanometry and the data will be registered in mm Hg, every 30 minutes,
Secondary outcome [2] 322801 0
Quality of life measured by SF 12, SF 16, COOP/WONCA questionaries in patients with stage 5 chronic kidney disease
Timepoint [2] 322801 0
12 weeks post commencement of intervention/placebo.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Numbers will be generated by radioactive decay.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is an exploratory study. Previous studies have shown no difference between groups using levocarnitine, therefore can not be used to calculate sample size. The calculation will be based on convenience sample considering previous studies and the size of our population in Hemodialysis.
Distribution will be assessed with the Shapiro-Wilks test.
The difference between continuous variables will be evaluated with one-way ANOVA test.
The difference between nominal variables will be evaluated with the Chi-square test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2016
Date of last participant enrolment
Anticipated
10/06/2016
Actual
15/12/2016
Date of last data collection
Anticipated
Actual
2/03/2017
Sample size
Target
30
Accrual to date
Final
33
Recruitment outside Australia
Country [1] 7809 0
Mexico
State/province [1] 7809 0
Nuevo Leon

Funding & Sponsors
Funding source category [1] 293339 0
Hospital
Name [1] 293339 0
Unidad de Hemodialisis del Hospital Universitario “Dr. Jose Eleuterio Gonzalez” de la Universidad Autonoma de Nuevo Leon
Country [1] 293339 0
Mexico
Primary sponsor type
Hospital
Name
Unidad de Hemodialisis del Hospital Universitario “Dr. Jose Eleuterio Gonzalez” de la Universidad Autonoma de Nuevo Leon
Address
Av. Francisco I. Madero s/n, Col. Mitras Centro, C. P. 64460. Monterrey, Nuevo Leon, Mexico.
Country
Mexico
Secondary sponsor category [1] 292158 0
None
Name [1] 292158 0
Address [1] 292158 0
Country [1] 292158 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294807 0
UANL Faculty of Medicine Ethics Committee
Ethics committee address [1] 294807 0
Av. Francisco I. Madero s/n, Col. Mitras Centro, C. P. 64460. Monterrey, Nuevo Leon, Mexico.
Ethics committee country [1] 294807 0
Mexico
Date submitted for ethics approval [1] 294807 0
14/09/2014
Approval date [1] 294807 0
13/11/2014
Ethics approval number [1] 294807 0
MI14-008

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65110 0
Dr Hector Raul Ibarra-Sifuentes
Address 65110 0
Internal Medicine, Faculty of Medicine, UANL, Av. Francisco I. Madero s/n, Col. Mitras Centro, C. P. 64460. Monterrey, Nuevo Leon, Mexico.
Country 65110 0
Mexico
Phone 65110 0
+528183488928
Fax 65110 0
Email 65110 0
[email protected]
Contact person for public queries
Name 65111 0
Dr Hector Raul Ibarra-Sifuentes
Address 65111 0
Internal Medicine, Faculty of Medicine, UANL, Av. Francisco I. Madero s/n, Col. Mitras Centro, C. P. 64460. Monterrey, Nuevo Leon, Mexico.
Country 65111 0
Mexico
Phone 65111 0
+528183488928
Fax 65111 0
Email 65111 0
[email protected]
Contact person for scientific queries
Name 65112 0
Dr Hector Raul Ibarra-Sifuentes
Address 65112 0
Internal Medicine, Faculty of Medicine, UANL, Av. Francisco I. Madero s/n, Col. Mitras Centro, C. P. 64460. Monterrey, Nuevo Leon, Mexico.
Country 65112 0
Mexico
Phone 65112 0
+528183488928
Fax 65112 0
Email 65112 0
[email protected]

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