Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CER 03-159; SHR 369-08
Study information
Scientific title
Renal function during the perioperative period of liver transplantation
Acronym
Study hypothesis
Hyperreninism is the major mediator of transient and acute anuria during the anhepatic phase of liver transplantation.
Ethics approval(s)
Ethics Committee of the Geneva University Hospitals (Commission central d'éthique de la recherche sur l'être humain des HUG). Date of approval: 24/01/2004 (ref: CER 03-159)
Study design
Observational, prospective, cross-sectional study
Primary study design
Observational
Secondary study design
Cross-section survey
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Liver transplantation
Intervention
Observational study: Blood sampling for biologic assessment of renal function at the time of inclusion in the waiting list, at the time of anaesthesia induction on the day of liver transplantation, during the anhepatic phase, 24 hours later and finally at 6 months.
Intervention type
Other
Primary outcome measure
Renal function: plasma renin activity, assessed in all blood samples (see Interventions).
Secondary outcome measures
The following were assessed in all blood samples (see Interventions):
1. Cystatin C
2. Natraemia
Overall study start date
01/08/2004
Overall study end date
01/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Both males and females
2. Age 17-70 years
3. Patients scheduled for liver transplantation
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
30
Participant exclusion criteria
Incapacity to comprehend the study protocol
Recruitment start date
01/08/2004
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Switzerland
Study participating centre
Hopitaux Universitaires de Geneve
Geneva
1211
Switzerland
Sponsor information
Organisation
Geneva University Hospitals (Hôpitaux Universitaires de Genève) (Switzerland)
Sponsor details
24 Micheli du Crest
Geneva
1211
Switzerland
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
Geneva University Hospitals (Hôpitaux Universitaires de Genève) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|