A cohort study of haemodialysis patients based on hepatic magnetic resonance imaging

Analysis of hepatic iron stores of haemodialysis patients by magnetic resonance imaging: a cross-sectional and longitudinal study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN80100088

Enrollment

600

Registered

2011-06-14

Start date

2005-03-01

Completion date

Unknown

Last updated

2022-09-26

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

Conditions

Chronic kidney disease Urological and Genital Diseases Chronic nephritic syndrome

Interventions

Current interventions as of 08/09/2016: 1. Non-randomised measurement of hepatic iron content by means of T1 and T2 contrast magnetic resonance imaging (MRI) on a Sigma MRI unit (GE Me

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients of either sex 2. Undergoing chronic intermittent bipuncture bicarbonate hemodialysis (with ultrapure dialysate single use biocompatible membranes) three times a week Added 18/07/2013: 3. or peritoneal dialysis Added 23/10/2018: 4. At initiation of dialysis and with longitudinal follow-up

Exclusion criteria

Exclusion criteria: 1. Refusal to participate in the study 2. Poor compliance with the dialysis therapy schedule 3. Age < 18 years 4. Severe cognitive impairment 5. Claustrophobia 6. Hepatic cirrhosis 7. Overt inflammatory or infectious disease 8. Malnutrition 9. Recent major bleeding (< 3 months), major surgery (< 3 months), transfusion dependency, recent transfusion (< 3 months) 10. Intractable malignancy 11. Cardiac pacemakers and metallic cardiac valves

Design outcomes

Primary

Measure	Time frame
1. Determination of iron content (micromol/g/dry weight) 2. Percentage of patients with abnormal iron liver content (mild, moderate and severe overload) 3. As hepatic MRI accurately detects liver iron overload exceeding 50 micromol/g, the upper limit of normal was set at 50 micromol/g for this study 4. Values between 51 and 100 micromol/g will be considered to represent mild iron overload, values between 101 and 200 micromol/g moderate iron overload; and values >201 micromol/g severe iron overload. 5. MRI for quantification of hepatic iron stores will be performed (as possible) at least seven days after iron infusion Added 18/07/2013: 6. Spleen involvement 7. Heart (cardiac) involvement Added 23/10/2018: 8. Liver fat fraction measured by R2* relaxometry with IDEAL IQ algorithm and Rennes University Gandon’s algorithm, and iron content in pancreas measured by R2* relaxometry	—

Measure

Time frame

1. Determination of iron content (micromol/g/dry weight) 2. Percentage of patients with abnormal iron liver content (mild, moderate and severe overload) 3. As hepatic MRI accurately detects liver iron overload exceeding 50 micromol/g, the upper limit of normal was set at 50 micromol/g for this study 4. Values between 51 and 100 micromol/g will be considered to represent mild iron overload, values between 101 and 200 micromol/g moderate iron overload; and values >201 micromol/g severe iron overload. 5. MRI for quantification of hepatic iron stores will be performed (as possible) at least seven days after iron infusion Added 18/07/2013: 6. Spleen involvement 7. Heart (cardiac) involvement Added 23/10/2018: 8. Liver fat fraction measured by R2* relaxometry with IDEAL IQ algorithm and Rennes University Gandon’s algorithm, and iron content in pancreas measured by R2* relaxometry

—

Secondary

Measure	Time frame
1. Analysis of factors determining iron content: 1.1. Demographic characteristics 1.2. Clinical variables 1.3. Dialysis vintage 1.4. Erythropoiesis-stimulating agents (ESA) and iron therapies 1.5. AUDIT score 1.6. Mutation of HFE gene 2. Relationship between hepatic iron content and biochemical makers of iron status and hepcidine-25	—

Countries

France

Outcome results

None listed

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