Primary Objective: The main objective of this study is to determine whether MRI and ultrasound are capable to distinguish the existence and extent of microcysts in a Dutch population of lithium treated patients.Secondary Objective(s): to determine…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The prevalence and a semi-quantitative measurement of the number and size of
microcysts in lithium treated patients.
Secondary outcome
Relation between MRI and ultrasound results * presence of microcysts * and
clinical parameters (duration of lithium therapy, plasma lithium concentration,
baseline plasma creatinine, sodium and potassium concentration and baseline
urinary osmolality)
Background summary
Lithium therapy is associated with several forms of renal injury, including the
development of microcysts. Importantly, these microcysts distinguish lithium
treated patients from other patients with renal disease. The microcysts
originate from distal and collecting tubules and are localized in both the
cortex and the medulla. Up until now these microcysts have been described
predominantly in patients with advanced renal disease. Little is known about
the stage in witch these microcysts develop and whether an association exists
between these microcysts and other symptoms of renal injury
Study objective
Primary Objective: The main objective of this study is to determine whether MRI
and ultrasound are capable to distinguish the existence and extent of
microcysts in a Dutch population of lithium treated patients.
Secondary Objective(s): to determine the relation between
- duration of lithium exposure and renal microcysts
- the presence of LAR and renal microcysts
- to determine whether number and or extend of microcysts in lithium treated
patients is related to duration of lithium therapy.
Study design
This is a observational cross-sectional study.
Study burden and risks
Subjects will be asked to visit the out-patient clinic once. During this
visits, Renal MRI and renal ultrasound will be performed. This is a procedure
that takes about 1,5 hour of there time. Since no intravenous contrast is
necessary this procedure is not invasive for the subject and of little
inconvenience.
Subject may be confronted with incidental findings
Boelelaan 1117
Amsterdam 1081HV
NL
Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
Inclusioncriteria (patients)
- patients (m/f, age *18 years) with a bipolar disorder treated with lithium
Exclusion criteria
- general contra-indications for participation in a trial:
- inability to give informed consent
- pregnancy
- unstable psychiatric condition ;- Inability to undergo MRI.
- standard contra-indications for MR ( in accordance with the hospital protocol), such as the
presence of metallic fragments, clips or devices including implantable pacemakers and
implantable cardioverter-defibrillators, extreme overweight, claustrophia
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL45606.029.13 |