Goal Directed Therapy (GDT) in hip replacement

ISRCTN	ISRCTN11616985
DOI	https://doi.org/10.1186/ISRCTN11616985
Secondary identifying numbers	Prot. 2007/8/A

Submission date: 24/02/2011
Registration date: 18/03/2011
Last edited: 22/11/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Giorgio Della Rocca
Scientific

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

Phone	+39 (0)4 3255 9500
Email	giorgio.dellarocca@uniud.it

Study information

Study design	Single-centre randomised controlled 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	Goal Directed Therapy (GDT) in hip replacement: a single-centre randomised controlled trial
Study objectives	Goal Directed Therapy during regional anaesthesia in primary hip arhtroplasty changes intraoperative fluid management and decreases postoperative morbidity.
Ethics approval(s)	Direct Management Corporate University Hospital of Udine (Azienda Policlinico Universitario Gestione Diretta di Udine) approved on 12th March 2007 (ref Prot. 2007/8/A)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/04/2007
Completion date	01/04/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	40
Key inclusion criteria	Adult (>18 years old), patients undergoing primary hip arthroplasty under spinal anaesthesia
Key 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
Date of first enrolment	01/04/2007
Date of final enrolment	01/04/2008

Locations

Countries of recruitment

Italy

Study participating centre

Dpt of Anaesthesia and Intensive Care Medicine

Udine
33100
Italy

Sponsor information

Clinic of Anaesthesiology and Intensive care (CareClinica di Anestesia e Rianimazione) (Italy)
Hospital/treatment centre

Clinica di Anestesia e Rianimazione
AOU S. Maria della Misericordia
P.le S. Maria della Misericordia, 15
Udine
33100
Italy

Phone	+39 (0)4 3255 9501
Email	clinicaanestesiarianimazione@aoud.sanita.fvg.it

Funders

Funder type

University/education

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

No information available

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results		08/08/2008		No	No
Results article	results	01/10/2011		Yes	No