Studying Cognitive Outcome of Renal Transplantation with a Kidney of a Live Donor

Completed

Conditions: executive tasks and/or information processing
functioning of memory
language
10009841

Registration Number: NL-OMON41620

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 62

Inclusion Criteria

* Patients undergoing a scheduled renal transplantation with a live kidney donor before having started dialysis or within one year after starting dialysis and their donors.
* Sufficient visual and hearing acuity
* Dutch or English language fluency
* Willingness to give informed consent
* ABO compatible

Exclusion Criteria

* Pre-existing documented cognitive impairment
* A history of psychiatric illness
* Use of psychoactive substances
* A history of cerebrovascular disease (either transitory ischaemic attack or cerebrovascular accident)
* Brain injury
* Epilepsy
* Acute or chronic infections
* Malignancy
* Unstable coronary vascular disease
* Uncontrolled hypertension
* Liver disease or other metabolic disease leading to encephalopathy
* Diabetes mellitus
* Uncorrected anemia (Hb <7,0 mmol/L)
* MR contraindications, including implanted active devices or objects (e.g. cardiac pacemaker, implantable defibrillator, medication pump, intracranial aneurysm clips, cochlear implant and other implants), metal splinters near sensitive organs (e.g. eye, brain or lungs) or claustrophobia.
* Any condition that can be expected to interfere with complete follow-up
* Patients participating in group 1 of the ALLEGRO trial
* HLA-identical family transplantations

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The change in mental performance in kidney recipients at twelve months after<br /><br>transplantation compared to pre-transplantation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>o The change in mental performance in kidney recipients at twelve months after<br /><br>transplantation compared to the change in mental performance in kidney donors.<br /><br>o Changes in cortical, hippocampal, temporal atrophy and global cerebral<br /><br>atrophy, using both visual rating scales as well as volumetric analyses.<br /><br>o Changes in white matter lesions using both visual rating scales as well as<br /><br>volumetric analyses.<br /><br>o Presence of microinfarctions and areas with microbleeding at baseline and<br /><br>occurrence of new lesions during followup.<br /><br>o Change in cerebral blood flow as measured by arterial spin labelling.</p><br>