Study the frequency and severity of hyponatremia caused by Picoprep bowel preparation.
ID
Source
Brief title
Condition
- Gastrointestinal signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Presence of hyponatremia, defined as a serum sodium of <135.
- Presence of severe hyponatremia, either being a serum concentration <125 of
in case of severe symptoms (seizure, coma)
- Morbidity (altered mental status, seizures, headache)
Secondary outcome
N.a.
Background summary
Colonoscopy is the current standard method for imaging the mucosa of the entire
colon. The diagnostic accuracy and therapeutic safety of colonoscopy depends,
in part, on the quality of the colonic cleansing or preparation. Current
European guidelines recommend a (split) regimen of a polyethylene glycol (PEG)
solution or 2 liter PEG plus ascorbate or sodium picosulphate plus magnesium
citrate. PEG stays intraluminal and thus it is generally not expected that it
influences serum electrolytes significantly. Sodium picosulphate plus magnesium
citrate has both stimulative (picosulphate) and osmotic (magnesium citrate)
effects and thus can alter serum electrolytes and minerals. Despite its better
tolerance compared to PEG solution, bowel preparation with sodium picosulphate
plus magnesium citrate is associated with developing a hyponatremia in 1%-20%
of patients in clinical trials depending on its definition. Possible
contributing factors are a rise in anti-diuretic hormone, increased intake of
fluid and clearance of free water. Symptoms of hyponatremia depend on its
severity and the rapidity of its development. Nausea, malaise, headache,
lethargy, seizures, rhabdomyolysis and even a respiratory arrest may develop in
case of acute hyponatremia. Recently two patients developed severe hyponatremia
(seizures, coma) after they had taken Picoprep bowel preparation at our
department. Patients often complain about headaches after taking bowel
preparation which could also be caused by a decrease in the serum sodium level.
Study objective
Study the frequency and severity of hyponatremia caused by Picoprep bowel
preparation.
Study design
Prospective cohort study. are eligible for participation in this study.
Study burden and risks
The burden associated with participation is limited. This includes twotimes
bloodsampeling and for some participants (with a sodium <130) once urine
analysis.
There are no risks associated with participation.
Montessoriweg 1
Rotterdam 3083 AN
NL
Montessoriweg 1
Rotterdam 3083 AN
NL
Listed location countries
Age
Inclusion criteria
All adult patients using Picoprep bowel preparation scheduled for an outpatient based colonoscopy
Exclusion criteria
Natrium level at baseline <130 mmol/L
Age <18 years
Inability to give written informed consent
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 | NL60483.101.17 |