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| Name | Class |
|---|---|
| The Danish Medical Research Council | OTHER |
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The proposed controlled, randomized study aims to compare pre-dilution hemodiafiltration (HDF) and low flux hemodialysis (HD) regarding acute changes in the brain.
The study consist of two examination days placed one week apart. 12 HD patients will be recruited to the study. The patients will be randomly placed in two groups: Pre-dilution hemodiafiltration during the first examination and low flux hemodialysis during the second day or vice versa.
Brain Magnetic Resonance Imaging (MRI) will be obtained before and after both treatments. The MRI-data will later be processed to estimate brain volume changes during the two types of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First treatment HDF | Active Comparator | The patient will receive treatment with pre-dilution hemodiafiltration during the first examination day. During the second examination day the patient will receive treatment with low flux hemodialysis. |
|
| First treatment HD | Active Comparator | The patient will receive treatment with low flux hemodialysis during the first examination day. During the second examination day the patient will receive treatment with pre-dilution hemodiafiltration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDF during the first examination | Procedure | The patient will receive treatment with pre-dilution hemodiafiltration during the first examination. During the second examination the patient will receive treatment with low flux hemodialysis. MRI of the brain will be performed before and after the treatment. The MRI-data will later be processed to determine the degree of brain volume change due to the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Brain Volume Change (PBVC) | Brain volume before and after one hemodialysis session (4,5 hours) and one session of hemodiafiltration (4,5 hours). Dialysis sessions are performed one week apart. Randomization determines the order of treatment (hemodialysis vs hemodiafiltration). MRI-data will later be processed to estimate the PBVC. | Brain volume before and after one hemodialysis session (4,5 hours) and one session of hemodiafiltration (4,5 hours). Dialysis sessions are performed one week apart. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens D. Jensen, MD, PhD | Department of Renal Medicine C, Aarhus University Hospital, Skejby, Denmark | Study Director |
| Niels Johansen, BSc Medicine | Department of Renal Medicine C, Aarhus University Hospital, Skejby, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Renal Medicine C, Aarhus University Hospital, Skejby | Aarhus N | 8200 | Denmark | |||
| The MR-Research Centre, Aarhus University Hospital, Skejby |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38775299 | Derived | Kulkarni M, Prabhu AR, Rao IR, Nagaraju SP. Interventions for preventing haemodialysis dysequilibrium syndrome. Cochrane Database Syst Rev. 2024 May 22;5(5):CD015526. doi: 10.1002/14651858.CD015526.pub2. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| HD during the first examination | Procedure | The patient will receive treatment with low flux hemodialysis during the first examination. During the second examination the patient will receive treatment with pre-dilution hemodiafiltration. MRI of the brain will be performed before and after the treatment. The MRI-data will later be processed to determine the degree of brain volume change due to the treatment. |
|
| Aarhus N |
| 8200 |
| Denmark |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |