To determine if paracetamol can be used effectively and accurately in determining plasma volume as compared to the gold standard of 125I labeled ablumin in a non-pregnant patient population scheduled for plasmavolume measurement by I-125.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Comparison of the calculated plasma volumes using paracetamol and 125I labeled
albumin.
Secondary outcome
not applicable
Background summary
Plasma volume measurements are useful in determining which patients with
(pre-)eclampsia in their history are at risk of developing (pre-)eclampsia in a
future pregnancy. Lower plasma volumes combined with a high capillary leak,
indicates a higher risk for repetition of (pre-)eclampsia in a next pregnancy.
Currently I-125 is used in dertermination of plasma volume in non-pregnant
patients. Due to the radioactivity its use is not possible in pregnant
patients, which leaves us with no possibility to adeqately determine plasma
volume during pregnancy. Paracetamol may be attractive as an alternative to
measure plasma volume in pregnancy as it has a relatively long half life (2
hours in adults) compared to Evans blue and indocyanine green and is not
harmful to the fetus as is 125I labeled albumin.
Study objective
To determine if paracetamol can be used effectively and accurately in
determining plasma volume as compared to the gold standard of 125I labeled
ablumin in a non-pregnant patient population scheduled for plasmavolume
measurement by I-125.
Study design
The investigation is designed as a single center prospective, observational
cohort study.
Intervention
Administration of 1000 mg paracetamol intravenously over 10 minutes. For every
time blood samples are taken (4 times) an extra 3 ml will be withdrawn for the
study.
Study burden and risks
The burden for patientents will be that they will get 1000 mg of paracetamol
administered intravenously. This will take 10 minutes. During the study four
times an extra blood sample will be taken. as the needed intravenous cannulae
wil be present for the 125I labeled albumin study this will be no extra burden
to the patients. There are no known risks to administering 1000 mg of
paracetamol to non-allergic patients. Thera are no risks associated to
withdrawing 12 ml of blood from a patient. There will be no direct benefit for
patints. However this study may make it possible to safely determine plasma
volume in pregant patients in the future. this in turn may lead to changes in
clinical practice.
P.Debyelaan 25
Maastricht 6229HX
NL
P.Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
Over 18 years of age
(pre-)eclampsia in previous pregnancy
scheduled for plasma volume measurement
agree to participate in the study
Exclusion criteria
under the age of 18
pregnant
allergy for paracetamol
liver failure
refusal to participate in the study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL70761.068.19 |
| OMON | NL-OMON23031 |