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 2124, 2008; Lisbon, Portugal.
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21624138
Publication citations
-
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.