Contact information
Type
Scientific
Primary contact
Prof Claudia Spies
ORCID ID
Contact details
Charitéplatz 1
Berlin
10117
Germany
+49 (0)30 450 55 10 01
claudia.spies@charite.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
Ethics Committee of Charité - University Medicine Berlin, 11/03/2008
Study design
Prospective randomised double-blinded two-arm single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
15/06/2008
Overall trial end date
30/12/2011
Reason abandoned (if study stopped)
Lack of staff/facilities/resources
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
15/06/2008
Recruitment end date
30/12/2011
Locations
Countries of recruitment
Germany
Trial participating centre
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin)
Berlin
10117
Germany
Sponsor information
Organisation
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Sponsor details
Chariteplatz 1
Berlin
10117
Germany
-
anaesthesie-virchow-klinikum@charite.de
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Charité Universitätsmedizin Berlin
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
Germany
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list