Hemiarthroplasty of femoral neck fractures Musculoskeletal Diseases Fracture of femur
Conditions
Interventions
1. Targeted-volume application guided by oesophageal Doppler
only during the primary operation
2. Post-operative directives versus conventional volume application
only during the time the patient is in the intensive care unit (ICU)/intermediate care unit (IMCU) to finish post-operative directives (POD) 0 on the first post-operative day one at 8 am.
The follow-
Sponsors
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged greater than or equal to 60 years, either sex 2. Written informed consent of the patient 3. Anamnestically two or more years post-menopausal or surgically sterile 4. Patients with dislocated femoral neck fracture which is not older than 24 hours and will be operated within the next 24 hours
Exclusion criteria
Exclusion criteria: 1. Aged less than 60 years 2. No written consent from patient 3. Inability to communicate safely in German 4. Unwillingness to allow storage and sharing of anonymised disease data in the context of the clinical study 5. Simultaneous participation of the patient in another study or having been in a study which was terminated less than one month ago and not planned within the next three months 6. Accommodation in an institution due to an official or judicial order 7. Members of staff of the Charité 8. Advanced disease of the oesophagus of nasopharyngeal cavity 9. Operations in the area of the oesophagus or nasopharynx within the last two months 10. Liver disease (Child B or C cirrhosis, End-Stage Liver Disease [MELD] score greater than 10) 11. Condition after acute or chronic pancreatitis 12. History of bleeding tendency 13. Von Willebrands disease 14. Neurological or psychiatric disease 15. Chronic heart failure New York Heart Association (NYHA) class IV 16. American Society of Anaesthesiologists (ASA) classification greater than III 17. Renal failure (serum creatinine greater than 2.0 mg/dl or greater than 150 µmol/l or dependency of haemodialysis) 18. Existence of a pulmonary oedema in the preoperative chest x-ray 19. Allergy to hydroxyethyl starch or other ingredients of the intravenous solutions 20. History of intracranial haemorrhage within one year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peri-operative incidence of delirium, examined the whole time during the hospital stay of the patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Frequency of alcohol and drug abuse in patients undergoing femoral neck repair, examined directly after inclusion of the patient in the study 2. Peri-operative incidence of pulmonary, renal and cardiovascular dysfunction and of protocol violations, examined the whole time during the hospital stay of the patient 3. Post-operative incidence of infections, examined the whole time during the hospital stay of the patient 4. Quality of life (measured using the EuroQoL instrument), examined after inclusion in the study and 90 days after the operation | — |
Countries
Germany
Outcome results
None listed