Study Results
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Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2015-10-31
2020-12-31
Brief Summary
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Detailed Description
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A series of functional renal MRI scans will be performed (These scans do not constitute part patients routine clinical care). The results will initially be used to assess renal perfusion and fibrosis in patients with AKI and CKD. Subsequent analysis will be used to identify specific markers on the renal MRI scans that differentiate chronic kidney damage from acute injury to the kidney. Finally results will be used to stratify patients with AKI and CKD into low and high risk of subsequent deterioration in renal function.
AKI Cohort
25 patients with AKI stage 2/3 with or without renal replacement therapy (RRT) will undergo functional renal MRI imaging at day 0, day 90 and day 365.
First Study Scan (Day 0): A functional renal MRI scan will be performed during an admission to hospital with an episode of AKI 2/3. Vital signs and SOFA score will be recorded on the day of the scan.
Renal function assessment will occur± 2 days either side of the scan with an Iohexol clearance test.
Second Study Scan (Day 90): Repeat functional renal MRI imaging will be planned at 90 days (±14 days) after the 1st study scan day.
Renal function assessment will occur±7 days either side of the scan with an Iohexol clearance test.
Third Study Scan (Day 365): The final functional renal MRI imaging will take place 12 months (±30 days) after the 1st study scan day. Renal function assessment will occur±7 days either side of the scan with an Iohexol clearance test.
CKD Cohort:
25 patients with CKD stage 3-4 eGFR 20-59ml/min/1.73m2 will undergo functional renal MRI imaging at day 0, day 7 and day 365.
First Study Scan (Day 0): A functional renal MRI scan will be performed as an outpatient. Vital signs will be recorded on the day of the scan.
Renal function assessment will occur ±7 days either side of the scan with an Iohexol clearance test.
Second Study Scan (Day 7): A functional renal MRI scan will be performed as an outpatient. Vital signs will be recorded on the day of the scan.
Third Study Scan (Day 365): The second functional renal MRI imaging will take place 12 months (±30 days) after the 1st study scan day. Renal function assessment will occur±7 days either side of the scan with an Iohexol clearance test.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Chronic Kidney Disease
CKD stage 3-4 eGFR 59-20mls/min/1.73 '3 Tesla multiparametric MR: Renal MRI Scan to assess blood flow, perfusion, oxygenation and microstructure (MR T1 relaxation time and diffusion).
Each patient will have 3 renal MRI scans. renal histopathology scoring: Blinded fibrosis scoring of renal histopathology (If biopsy performed for clinical indication) Iohexol clearance test: Blood and urine sampling around scan sessions; this will include routine patient care biochemistry and haematology panel.
urine protein and albumin measurements, stored plasma/serum/urine for subsequent analysis.
Iohexol clearance to measure GFR within 1 week of the scan session
3 Tesla multiparametric MR
Renal MRI Scan to assess blood flow, perfusion, oxygenation and microstructure (MR T1 relaxation time and diffusion). Each patient will have 3 renal MRI scans.
renal histopathology scoring
Blinded fibrosis scoring of renal histopathology (If biopsy performed for clinical indication)
Blood and urine sampling
Blood and urine sampling around scan sessions; this will include routine patient care biochemistry and haematology panel,
urine protein and albumin measurements, stored plasma/serum/urine for subsequent analysis
Iohexol clearance test
Iohexol clearance to measure GFR within 1 week of the scan session
Acute Kidney Injury
AKI stage 2-3 '3 Tesla multiparametric MR: Renal MRI Scan to assess blood flow, perfusion, oxygenation and microstructure (MR T1 relaxation time and diffusion).
Each patient will have 3 renal MRI scans. Iohexol clearance test: Blood and urine sampling around scan sessions; this will include routine patient care biochemistry and haematology panel.
renal histopathology scoring: Blinded fibrosis scoring of renal histopathology (If biopsy performed for clinical indication) urine protein and albumin measurements, stored plasma/serum/urine for subsequent analysis.
Iohexol clearance to measure GFR within 1 week of the scan session
3 Tesla multiparametric MR
Renal MRI Scan to assess blood flow, perfusion, oxygenation and microstructure (MR T1 relaxation time and diffusion). Each patient will have 3 renal MRI scans.
renal histopathology scoring
Blinded fibrosis scoring of renal histopathology (If biopsy performed for clinical indication)
Blood and urine sampling
Blood and urine sampling around scan sessions; this will include routine patient care biochemistry and haematology panel,
urine protein and albumin measurements, stored plasma/serum/urine for subsequent analysis
Iohexol clearance test
Iohexol clearance to measure GFR within 1 week of the scan session
Interventions
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3 Tesla multiparametric MR
Renal MRI Scan to assess blood flow, perfusion, oxygenation and microstructure (MR T1 relaxation time and diffusion). Each patient will have 3 renal MRI scans.
renal histopathology scoring
Blinded fibrosis scoring of renal histopathology (If biopsy performed for clinical indication)
Blood and urine sampling
Blood and urine sampling around scan sessions; this will include routine patient care biochemistry and haematology panel,
urine protein and albumin measurements, stored plasma/serum/urine for subsequent analysis
Iohexol clearance test
Iohexol clearance to measure GFR within 1 week of the scan session
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Acute Kidney Injury stage 2/3 (duration \>24 hours) including patients requiring renal replacement therapy
* \>18 years \& \< 95 years
* Able to give informed consent
CKD Patients:
* Patients with CKD Stage 3 - 4 (e GFR\> 20 and \<60 ml/min)
* \>18 years \& \< 95 years
* Able to give informed consent
Exclusion Criteria
* Renal transplant
* Contraindications to MRI e.g. claustrophobia, cardiac pacemaker, metallic fragments or implants
* Pregnancy or breast feeding or intending pregnancy
* Unable to give consent or understand written information
* Pre-existing CKD of any stage as per eGFR
* Obstructive uropathy
* AKI duration \<24hrs, in the opinion of the investigator
* Not medically fit for transfer to MRI scan, in the opinion of the clinical team or the investigator
* Iodine allergy
* Patients unable to comply with basic verbal English commands whilst in scanner due to special communication needs
CKD Patients:
* Renal transplant
* Contraindications to MRI e.g. claustrophobia, cardiac pacemaker, metallic fragments or implants
* Pregnancy or breast feeding or intending pregnancy
* Unable to give consent or understand written information
* Unstable CKD; AKI Stage 1 or more or other unplanned hospital admission within the last 90 days
* Iodine allergy
* Patients unable to comply with basic verbal English commands whilst in scanner due to special communication needs
18 Years
95 Years
ALL
No
Sponsors
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University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Maarten Taal
Role: PRINCIPAL_INVESTIGATOR
univeristy of nottingham
nick selby
Role: STUDY_CHAIR
University of Nottingham
Locations
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Royal Derby Hospital
Derby, East Midlands, United Kingdom
Countries
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Central Contacts
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Other Identifiers
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15040
Identifier Type: -
Identifier Source: org_study_id
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