Objectives: The objective of the study is to observe the sorbitol clearance and compare this to ICG clearance in different circumstances of normal and compromised liver blood flow.
ID
Source
Brief title
Condition
- Other condition
- Hepatic and hepatobiliary disorders
Synonym
Health condition
sepsis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study objectives;
The main study objective is the clinical use of D-sorbitol plasma clearance as
a measure of functional liver blood flow.
Secondary outcome
Not applicable.
Background summary
Summary: D-sorbitol is a polyol, a sugar-alcohol. It has been used as an
artificial sweetener in the food industry, and was used in the past as an
intravenous fluid, for instance in total parenteral feeding solutions. It is
metabolised in the liver through the fructose pathway. The rate of metabolism
is dependant on the speed with which the substance is transported to the
hepatocytes and thus dependant on blood flow through the liver. Therefore, the
plasma disappearance rate of D-sorbitol can be used as a measure of blood
circulation through, and function of the liver. This method has been used in
the past in patients with liver failure based on cirrhosis. Only sporadically
has D-sorbitol plasma clearance been used in the ICU, and only in patients with
cirrhosis.
Apart from general factors such as liver enzymes and clotting factors, the
plasma clearance of several substances has been used as a measure of function
of, or blood circulation through the liver. The ideal substance is non-toxic,
inert, is exclusively extracted from the circulation by the liver and has a
high extraction ratio, i.e. the substance is rapidly cleared by the liver. The
'gold standard' is the plasma disappearance rate of indocyanine green (ICG).
D-sorbitol is a substance with a high liver extraction ratio (0.96), and the
plasma clearance is almost completely liver dependant, apart from a smaller,
easy to measure and much lower renal clearance. The target of this research
project is to establish the clinical use of D-sorbitol in the ICU and a
comparison with ICG.
Study objective
Objectives: The objective of the study is to observe the sorbitol clearance and
compare this to ICG clearance in different circumstances of normal and
compromised liver blood flow.
Study design
Study design: The study will be carried out in the Operation Department and the
Department of Intensive Care of the Erasmus University Medical Center (B. van
der Hoven, MD and dr. D. Gommers, MD PhD) and is designed as a single-center
observational study.
Intervention
Injection of two different substances and measuring plasma clearance to
evaluate the functional liver blood flow in all groups of patients.
Study burden and risks
Risk assessment: The measurements pose no additional risks to the patient. The
methods used are based on data from extensive earlier research in patients with
and without disturbed liver function and our own animal model research.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
• Inclusion criteria:;o Age 18 years or older.;o Informed consent of the test person or from her/his lawful representative.;o Patients admitted for liver transplant, hemi-hepatectomy for primary or secondary liver malignancy, or sepsis. ;The control group will be recruited from patients admitted for subarachnoid bleeding without liver disease.
Exclusion criteria
• Exclusion criteria:;o No informed consent.;o Allergy for the administered substances, including inborn errors of the *fructose-pathway*.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTRNL32291.078.12-NL |
| CCMO | NL32291.000.12 |