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

Not Applicable

Completed

• Conditions: Elective liver resection surgery; Surgery; Liver resection

• Registration Number: ISRCTN64578872
• Lead Sponsor: Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-03
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stroke volume before intra-operative start of liver resection

Secondary Outcome Measures

Name	Time	Method
All determined within the study period of 8 post-operative days:<br>1. Intra-operative and post-operative haemodynamic parameters<br>2. Intra-operative and post-operative blood loss<br>3. (Cumulative) frequency of organ dysfunctions (cerebral, pulmonal, renal, abdominal, cardiovascular)<br>4. Post-operative liver function (LiMAx-test, ICG-Clearance, liver Doppler, laboratory tests: enzymatic and chemical parameters)<br>5. Peri-operative weight change<br>6. Post-operative incidence of infections <br>7. Satisfaction of the patients, the surgeons and anaesthetists <br>8. Time to fulfilling discharge criteria<br>9. Length of intensive care stay and hospital stay (LOS)<br>10. Quality of life measure (EQ-5D)<br>11. Laboratory tests: peri-operative endothelial and immunological alterations