Haemodynamic protocols in traumatology
| ISRCTN | ISRCTN66123742 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66123742 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/06/2008
- Registration date
- 31/07/2008
- Last edited
- 09/03/2016
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Claudia Spies
Scientific
Scientific
Charitéplatz 1
Berlin
10117
Germany
| Phone | +49 (0)30 450 55 10 01 |
|---|---|
| claudia.spies@charite.de |
Study information
| Study design | Prospective randomised double-blinded two-arm single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The feasability, the implementation and the influence on patient outcome of an intra-operative goal-directed haemodynamic protocol and post-operative directives in comparision to conventional treatment in cemented and uncemented hemiarthroplasty of femoral neck fractures: a pilot study |
| Study objectives | Primary hypothesis: The use of an intra-operative goal-directed haemodynamic protocol and post-operative directives reduces the incidence of delirium in comparison to conventional treatment in cemented and uncemented hemiarthroplasty of femoral neck fractures. Secondary hypothesis 1: The use of an intra-operative goal-directed haemodynamic protocol and post-operative directives peri-operatively reduces the occurrence of pulmonary, renal and cardiovascular dysfunction and the incidence of infections and improves quality of life in comparision to conventional treatment without influence of the kind of fixation in cemented and uncemented hemiarthroplasty of femoral neck fractures. Secondary hypothesis 2: The use of an intra-operative goal-directed haemodynamic protocol and post-operative directives is feasible with a low rate of protocol violations to reach a high implementation rate. |
| Ethics approval(s) | Ethics Committee of Charité - University Medicine Berlin, 11/03/2008 |
| Health condition(s) or problem(s) studied | Hemiarthroplasty of femoral neck fractures |
| Intervention | 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-up will be up hospital discharge or up to the 30th post-operative day. The patient will be contacted 90 days after the operation. |
| Intervention type | Other |
| Primary outcome measure | Peri-operative incidence of delirium, examined the whole time during the hospital stay of the patient. |
| Secondary outcome measures | 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 |
| Overall study start date | 15/06/2008 |
| Completion date | 30/12/2011 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/06/2008 |
| Date of final enrolment | 30/12/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin)
Berlin
10117
Germany
10117
Germany
Sponsor information
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
University/education
University/education
Chariteplatz 1
Berlin
10117
Germany
| anaesthesie-virchow-klinikum@charite.de | |
| Website | http://www.charite.de/ |
"ROR" |
https://ror.org/001w7jn25 |
Funders
Funder type
University/education
Charité Universitätsmedizin Berlin
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Medical School - Charité - University Medicine Berlin
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
Updated 09/03/2016: The study was never conducted after receiving the ethical vote due to shortage of staff.
On 03/11/2010 the overall trial end date was changed from 15/06/2010 to 30/12/2011.
