Haemodynamic protocols in traumatology

ISRCTN	ISRCTN66123742
DOI	https://doi.org/10.1186/ISRCTN66123742
Protocol serial number	N/A
Sponsor	Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Funder	Charité Universitätsmedizin Berlin

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

Charitéplatz 1
Berlin
10117
Germany

Phone	+49 (0)30 450 55 10 01
Email	claudia.spies@charite.de

Study information

Primary study design	Interventional
Study design	Prospective randomised double-blinded two-arm single-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Peri-operative incidence of delirium, examined the whole time during the hospital stay of the patient.
Key secondary outcome measure(s)	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
Completion date	30/12/2011
Reason abandoned (if study stopped)	Lack of staff/facilities/resources

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.