Condition category
Surgery
Date applied
10/03/2009
Date assigned
03/12/2009
Last edited
20/07/2015
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

Prof Claudia Spies

ORCID ID

Contact details

Augustenburger Platz 1
Berlin
13353
Germany
-
claudia.spies@charite.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Intra-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

Acronym

Study hypothesis

Compared 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

Ethics Committee of Charité - University Medicine Berlin, 22/01/2009

Study design

Prospective randomised controlled blinded three-armed single-centre pilot trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Elective liver resection surgery

Intervention

The 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 type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Stroke volume before intra-operative start of liver resection

Secondary outcome measures

All 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 trial start date

01/03/2009

Overall trial end date

29/08/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged 18 years and over, either sex, undergoing elective liver resection in Charité - University Medicine Berlin, Campus Virchow-Clinic

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. 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

Recruitment start date

01/03/2009

Recruitment end date

29/08/2010

Locations

Countries of recruitment

Germany

Trial participating centre

Augustenburger Platz 1
Berlin
13353
Germany

Sponsor information

Organisation

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

Sponsor details

Chariteplatz 1
Berlin
10117
Germany
-
anaesthesie-virchow-klinikum@charite.de

Sponsor type

Hospital/treatment centre

Website

http://www.charite.de/

Funders

Funder type

Hospital/treatment centre

Funder name

Charité Universitätsmedizin Berlin

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Germany

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26186702

Publication citations

Additional files

Editorial Notes