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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN64578872
Enrollment
60
Registered
2009-12-03
Start date
2009-03-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elective liver resection surgery Surgery Liver resection

Interventions

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 oe

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Stroke volume before intra-operative start of liver resection

Secondary

MeasureTime frame
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

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026