Condition category
Urological and Genital Diseases
Date applied
21/06/2008
Date assigned
12/09/2008
Last edited
12/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Eduardo Schiffer

ORCID ID

Contact details

Hopitaux Universitaires de Geneve
24 Micheli-du-Crest
Geneva
1211
Switzerland

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/08/2004

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females
2. Age 17-70 years
3. Patients scheduled for liver transplantation

Participant type

Patient

Age group

Adult

Gender

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

Trial 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

http://www.hug-ge.ch

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes