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| [ ...Back to search results ] | [ Print-friendly version ] |
| 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 |
| ClinicalTrials.gov identifier | |
| Public title | A pilot study of a goal-directed haemodynamic protocol comparison by monitoring with LiDCOrapid or oesophageal Doppler and conventional therapy during liver resection |
| 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 | N/A |
| Serial number at source | N/A |
| 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 anticipated end date; the initial anticipated end date of this trial was 01/03/2010. |
| Lay summary | |
| Ethics approval | Ethics Committee of Charité - University Medicine Berlin approved on the 22nd January 2009 |
| Study design | Prospective randomised controlled blinded three-armed single centre pilot trial |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Elective liver resection surgery |
| Participants - inclusion criteria | Patients aged 18 years and over, either sex, undergoing elective liver resection in Charité - University Medicine Berlin, Campus Virchow-Clinic |
| Participants - 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 |
| Anticipated start date | 01/03/2009 |
| Anticipated end date | 29/08/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 60 |
| 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 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). |
| Primary outcome measure(s) | Stroke volume before intra-operative start of liver resection |
| Secondary outcome measure(s) |
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 |
| Sources of funding | Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany) |
| Trial website | |
| Publications | |
| Contact name | Prof Claudia Spies |
| Address | Augustenburger Platz 1 |
| City/town | Berlin |
| Zip/Postcode | 13353 |
| Country | Germany |
| claudia.spies@charite.de | |
| Sponsor | Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany) |
| Address | Chariteplatz 1 |
| City/town | Berlin |
| Zip/Postcode | 10117 |
| Country | Germany |
| anaesthesie-virchow-klinikum@charite.de | |
| Sponsor website: | http://www.charite.de/ |
| Date applied | 10/03/2009 |
| Last edited | 03/11/2010 |
| Date ISRCTN assigned | 03/12/2009 |
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