Increasing dialysate magnesium (IDM): the effect on blood vessel stiffness, blood pressure, and changes to the functioning of the lining of blood vessels in patients receiving hemodialysis treatment

Consequences of supraphysiological dialysate magnesium on arterial stiffness, hemodynamic profile and endothelial function in hemodialysis: observational cross-over study followed by a follow-up phase

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN74139255

Enrollment

Registered

2020-06-22

Start date

2018-08-20

Completion date

Unknown

Last updated

2020-10-19

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

Conditions

Arterial stiffness, hemodynamic profile and endothelial function in hemodialysis patients Circulatory System Arterial stiffness, hemodynamic profile, endothelial function, dialysis, hemodialysis

Interventions

4-week cross-over study aimed at investigating the consequences of increasing dialysate magnesium (D-Mg2+) from 0.50 to 0.75 mmol/L on arterial stiffness, hemodynamic profile, and endothelial function

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Receiving treatment in the participating center with maintenance hemodialysis for =3 months 2. Aged =18 years 3. Able to understand the protocol and to give written informed consent

Exclusion criteria

Exclusion criteria: 1. Acute illness requiring hospitalization 2. Pregnancy or risk of pregnancy

Design outcomes

Primary

Measure	Time frame
1. Vascular stiffness as estimated by pulse wave velocity (PWV), augmentation index (AI), and pulse pressure (PP) using a conventional brachial cuff for adults with an integrated high-fidelity pressure sensor, Mobil-o-Graph on the non fistula arm to assess systolic blood pressure, diastolic blood pressure, and heart rate which are assessed 3 times (at the beginning, after half of the time and at the end) during each haemodialysis session between baseline and 4 weeks	—

Measure

Time frame

1. Vascular stiffness as estimated by pulse wave velocity (PWV), augmentation index (AI), and pulse pressure (PP) using a conventional brachial cuff for adults with an integrated high-fidelity pressure sensor, Mobil-o-Graph on the non fistula arm to assess systolic blood pressure, diastolic blood pressure, and heart rate which are assessed 3 times (at the beginning, after half of the time and at the end) during each haemodialysis session between baseline and 4 weeks

—

Secondary

Measure	Time frame
1. Hemodynamic profile measured using a conventional brachial cuff for adults with an integrated high-fidelity pressure sensor, Mobil-o-Graph on the non fistula arm to assess systolic blood pressure, diastolic blood pressure, and heart rate which are assessed 3 times (at the beginning, after half of the time and at the end) during each haemodialysis session between baseline and 4 weeks. 2. Endothelial function, as measured by the reactive hyperemia index estimated with a validated, non operator-dependent, device for non-invasive measurement of endothelial function (EndoPAT 2000, Itamar Medical Inc., Israel) at baseline and 2 and 4 weeks 3. Incidence of intradialytic hypotension and bradicardia measured using a conventional brachial cuff for adults with an integrated high-fidelity pressure sensor, Mobil-o-Graph on the non fistula arm to assess systolic blood pressure, diastolic blood pressure, and heart rate which are assessed 3 times (at the beginning, after half of the time and at the end) during each haemodialysis session between baseline and 4 weeks. Intradialytic hypotension is defined as a decrease in systolic blood pressure of =20 mmHg or a decrease in mean arterial pressure (MAP) of =10 mmHg, and intradialytic bradycardia as an heart rate of =60 beats/min. 4. Incidence of pre-/post-dialytic hypermagnesaemia or hyper-/hypo-calcemia measured from ionized magnesium and ionized calcium using an ionometer (Microlyte 6 Analyzer, Kone Instruments, Espoo, Finland) pre- and post-haemodialysis at each haemodialysis session between baseline and 4 weeks 5. Changes in mineral and bone metabolism markers over the 6-month follow up period measured using ionized calcium and ionized magnesium assessed at 0, 1, 2, 3, 4, 5, and 6 months of follow up, and intact parathyroid hormone, 25-OH-Vitamin D, ionized magnesium and total magnesium levels assessed at 0, 3 and 6 months of follow up	—

Measure

Time frame

1. Hemodynamic profile measured using a conventional brachial cuff for adults with an integrated high-fidelity pressure sensor, Mobil-o-Graph on the non fistula arm to assess systolic blood pressure, diastolic blood pressure, and heart rate which are assessed 3 times (at the beginning, after half of the time and at the end) during each haemodialysis session between baseline and 4 weeks. 2. Endothelial function, as measured by the reactive hyperemia index estimated with a validated, non operator-dependent, device for non-invasive measurement of endothelial function (EndoPAT 2000, Itamar Medical Inc., Israel) at baseline and 2 and 4 weeks 3. Incidence of intradialytic hypotension and bradicardia measured using a conventional brachial cuff for adults with an integrated high-fidelity pressure sensor, Mobil-o-Graph on the non fistula arm to assess systolic blood pressure, diastolic blood pressure, and heart rate which are assessed 3 times (at the beginning, after half of the time and at the end) during each haemodialysis session between baseline and 4 weeks. Intradialytic hypotension is defined as a decrease in systolic blood pressure of =20 mmHg or a decrease in mean arterial pressure (MAP) of =10 mmHg, and intradialytic bradycardia as an heart rate of =60 beats/min. 4. Incidence of pre-/post-dialytic hypermagnesaemia or hyper-/hypo-calcemia measured from ionized magnesium and ionized calcium using an ionometer (Microlyte 6 Analyzer, Kone Instruments, Espoo, Finland) pre- and post-haemodialysis at each haemodialysis session between baseline and 4 weeks 5. Changes in mineral and bone metabolism markers over the 6-month follow up period measured using ionized calcium and ionized magnesium assessed at 0, 1, 2, 3, 4, 5, and 6 months of follow up, and intact parathyroid hormone, 25-OH-Vitamin D, ionized magnesium and total magnesium levels assessed at 0, 3 and 6 months of follow up

—

Countries

Switzerland

Contacts

Public ContactLuca Gabutti

luca.gabutti@eoc.ch+41 0918118464

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026