Condition category
Musculoskeletal Diseases
Date applied
24/02/2011
Date assigned
18/03/2011
Last edited
22/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Giorgio Della Rocca

ORCID ID

Contact details

Dpt of Anaesthesia and Intensive Care Medicine
of the Medical School of the University of Udine
Piazzale S. Maria della Misericordia
15
Udine
33100
Italy
+39 (0)4 3255 9500
giorgio.dellarocca@uniud.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Prot. 2007/8/A

Study information

Scientific title

Goal Directed Therapy (GDT) in hip replacement: a single-centre randomised controlled trial

Acronym

Study hypothesis

Goal Directed Therapy during regional anaesthesia in primary hip arhtroplasty changes intraoperative fluid management and decreases postoperative morbidity.

Ethics approval

Direct Management Corporate University Hospital of Udine (Azienda Policlinico Universitario Gestione Diretta di Udine) approved on 12th March 2007 (ref Prot. 2007/8/A)

Study design

Single-centre randomised controlled 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

Primary hip arthroplasty

Intervention

All patients will receive spinal anaesthesia was performed at the L3-L4 level with levobupivacaine 0.5% 15 mg.

CTRL group:
Patients randomised to the control group will receive Ringer lactate solution at 10 ml/kg/hour. 250 ml boluses of intra venous colloid will be administered to maintain blood pressure.

Goal Directed Therapy (GDT) group:
This group will be connected to the FloTrac/Vigileo (Edwards Lifesciences, CA, USA) haemodynamic monitoring system. Boluses of 250 ml of colloid will be administered until the stroke volume fails to further increase by a factor of 10%. If at this stage the DO2I is not greater than 600 ml/m2 then dobutamine will be started.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Intraoperative fluid management -fluid management will be recorded from the arrival to the anaesthetic room until discharge to the ward
2. Blood consumption will be recorded from arrival to the anaesthetic room until hospital discharge

Secondary outcome measures

Postoperative morbidity: assessed from discharge to the ward until hospital discharge by a modified postoperative morbidity survey (POMS)

Overall trial start date

01/04/2007

Overall trial end date

01/04/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Adult (>18 years old), patients undergoing primary hip arthroplasty under spinal anaesthesia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Patients refusing consent
2. Patients with planned admission to intensive care unit (ICU) postoperatively
3. Patients with a contraindication to spinal anaesthesia

Recruitment start date

01/04/2007

Recruitment end date

01/04/2008

Locations

Countries of recruitment

Italy

Trial participating centre

Dpt of Anaesthesia and Intensive Care Medicine
Udine
33100
Italy

Sponsor information

Organisation

Clinic of Anaesthesiology and Intensive care (CareClinica di Anestesia e Rianimazione) (Italy)

Sponsor details

Clinica di Anestesia e Rianimazione
AOU S. Maria della Misericordia
P.le S. Maria della Misericordia
15
Udine
33100
Italy
+39 (0)4 3255 9501
clinicaanestesiarianimazione@aoud.sanita.fvg.it

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

Department of Anaesthesia and Intensive Care Medicine-University of Udine (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1.Abstract submission to ESICM congress:
Cecconi M, Fasano N, Specogna B, et al. Haemodynamic management in hip replacement: standard management vs goal directed therapy. Paper presented at: 21st ESICM Annual Congress; September 21–24, 2008; Lisbon, Portugal.
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21624138

Publication citations

  1. Results

    Cecconi M, Fasano N, Langiano N, Divella M, Costa MG, Rhodes A, Della Rocca G, Goal-directed haemodynamic therapy during elective total hip arthroplasty under regional anaesthesia., Crit Care, 2011, 15, 3, R132, doi: 10.1186/cc10246.

Additional files

Editorial Notes