Condition category
Musculoskeletal Diseases
Date applied
15/06/2008
Date assigned
31/07/2008
Last edited
09/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.charite.de/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

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.