Status:
COMPLETED
HaemoDialysis Interventions to REduce Multi-Organ Dysfunction and Effect on Quality of Life Assessed by MRI Scanning
Lead Sponsor:
Fresenius Medical Care Deutschland GmbH
Conditions:
Renal Failure
Cardiovascular Diseases
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to characterise in detail cardiac, cerebral and renal structure, function and perfusion in patients on haemodialysis (HD) using magnetic imaging techniques. The effects of...
Detailed Description
The purpose of this study is to characterise in detail cardiac, cerebral and renal structure, function and perfusion in patients on haemodialysis (HD) using magnetic imaging techniques. The Primary ob...
Eligibility Criteria
Inclusion
Exclusion
- Change in dry weight (clinically defined) in 4 weeks prior to recruitment
- Dialysate composition other than: sodium≥137mmol/L, potassium≥2.0mmol/L, calcium≥1.5mmol/L, magnesium≥0.5mmol/L, glucose 1.0g/L
- Instability on dialysis in 4 weeks prior to recruitment leading to either:
- Emergency medical attention
- Infusion of additional fluid
- Loss in consciousness
- Arrhythmia
- Chest pain
- Or any other medical condition that precludes the scan session in opinion of the investigator
- Dialysed via a synthetic line, central venous catheter or graft
- Qa \< 500ml/min
- NYHA Stage IV heart failure (New York Heart Association)
- Active infection or malignancy
- Contraindication to MRI scanning including claustrophobia, pacemaker, metallic implants etc
- Pregnancy (pregnancy test will be conducted with female patients aged ≤ 55 years) or planning pregnancy or lactation period
- Medical conditions or overall physical frailty precludes scan session in opinion of investigator
- Unable or unwilling to provide informed consent
- Any condition which could interfere with the patient's ability to comply with the study
- Participation in an interventional clinical study during the preceding 30 days
- Inclusion Criteria:
- Age 18-80, male and female
- Informed consent signed and dated by study patient and investigator/authorised physician
- Average (4 weeks prior to recruitment) Ultrafiltration volumes ≥ 0.5 litres/ dialysis session
- Receiving dialysis via an arteriovenous fistula
- Must be able to follow simple instruction in English (on safety grounds for MRI scans) and be able to understand the nature and requirements of the study
- Stable dialysis prescription
- CKD5 (Chronic kidney disease) patients having renal replacement therapy with haemodialysis/ haemodiafiltration (\>90 days)
Key Trial Info
Start Date :
January 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2020
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03280901
Start Date
January 8 2018
End Date
August 20 2020
Last Update
January 15 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine
Nottingham, United Kingdom