A pilot study of a goal-directed haemodynamic protocol comparison by monitoring with LiDCOrapid or oesophageal Doppler and conventional therapy during liver resection

ISRCTN ISRCTN64578872
DOI https://doi.org/10.1186/ISRCTN64578872
Secondary identifying numbers N/A
Submission date
10/03/2009
Registration date
03/12/2009
Last edited
20/07/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Claudia Spies
Scientific

Augustenburger Platz 1
Berlin
13353
Germany

claudia.spies@charite.de

Study information

Study designProspective randomised controlled blinded three-armed single-centre pilot trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleIntra-operative comparison of a goal-directed haemodynamic protocol by monitoring with LiDCOrapid or oesophageal Doppler and conventional therapy during liver resection: a prospective, randomised, controlled, blinded, three-armed single-centre pilot study
Study objectivesCompared to conventional therapy an intra-operative goal-directed haemodynamic management by monitoring with LiDCOrapid or oesophageal Doppler improves haemodynamics measured by stroke volume (SV) in patients undergoing elective liver resection.

As of 03/11/2010 this record has been updated to include an extended overall trial end date; the initial overall trial end date was 01/03/2010.
Ethics approval(s)Ethics Committee of Charité - University Medicine Berlin, 22/01/2009
Health condition(s) or problem(s) studiedElective liver resection surgery
InterventionThe interventions will take place only during liver resection:
1. Conventional intra-operative haemodynamic management
2. Intra-opertive LiDCOrapid-guided haemodynamic management
3. Intra-operative oesophageal Doppler-guided haemodynamic management

The last study day of the patient will be on the post-operative day 8 or on the day of hospital discharge (less than 8 post-operative days).
Intervention typeProcedure/Surgery
Primary outcome measureStroke volume before intra-operative start of liver resection
Secondary outcome measuresAll determined within the study period of 8 post-operative days:
1. Intra-operative and post-operative haemodynamic parameters
2. Intra-operative and post-operative blood loss
3. (Cumulative) frequency of organ dysfunctions (cerebral, pulmonal, renal, abdominal, cardiovascular)
4. Post-operative liver function (LiMAx-test, ICG-Clearance, liver Doppler, laboratory tests: enzymatic and chemical parameters)
5. Peri-operative weight change
6. Post-operative incidence of infections
7. Satisfaction of the patients, the surgeons and anaesthetists
8. Time to fulfilling discharge criteria
9. Length of intensive care stay and hospital stay (LOS)
10. Quality of life measure (EQ-5D)
11. Laboratory tests: peri-operative endothelial and immunological alterations
Overall study start date01/03/2009
Completion date29/08/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants60
Key inclusion criteriaPatients aged 18 years and over, either sex, undergoing elective liver resection in Charité - University Medicine Berlin, Campus Virchow-Clinic
Key exclusion criteria1. Aged less than 18 years
2. No written informed consent from patient
3. For female patients: pregnancy or lactation
3. Inability to communicate freely in the German language
4. Lack of willingness to safe and hand out pseudonymised data within the clinical study
5. Simultaneous participation of the patient in another study
6. Accommodation in an institution due to an official or judicial order
7. Members of staff of the Charité
8. Unclear history of alcohol used disorder
9. Advanced disease of the oesophagus of nasopharyngeal cavity
10. Operations in the area of the oesophagus or nasopharynx within the last two months
11. History of bleeding tendency e.g. Von Willebrands disease
12. Neurological or psychiatric disease
13. Chronic heart failure New York Heart Association (NYHA) class IV
14. American Society of Anaesthesiologists (ASA) classification greater than IV
15. Chronic renal failure with dependency of haemodialysis
16. Existence of a pulmonary oedema in the pre-operative chest x-ray
17. History of intracranial haemorrhage within one year
18. Allergy to gelatin
Date of first enrolment01/03/2009
Date of final enrolment29/08/2010

Locations

Countries of recruitment

  • Germany

Study participating centre

Augustenburger Platz 1
Berlin
13353
Germany

Sponsor information

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Hospital/treatment centre

Chariteplatz 1
Berlin
10117
Germany

anaesthesie-virchow-klinikum@charite.de
http://www.charite.de/
ROR logo https://ror.org/001w7jn25

Funders

Funder type

Hospital/treatment centre

Charité Universitätsmedizin Berlin
Private sector organisation / For-profit companies (industry)
Alternative name(s)
Medical School - Charité - University Medicine Berlin
Location
Germany

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 17/07/2015 Yes No
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