Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2611/2002
Study information
Scientific title
Acronym
Study hypothesis
We aimed to investigate the effect of oxygen delivery index (DO2I) optimisation with fluids versus with fluids and dobutamine on 60-day hospital mortality and incidence of complications.
Ethics approval
Ethics approval received from the local medical ethics board on the 13th May 2002 (ref: 2611/2002).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
High-risk patients undergoing prolonged surgery
Intervention
Therapy consisted of pulmonary artery catheter (PAC)-guided haemodynamic optimisation during the operation and 24 hours postoperatively, using either fluids alone or fluids and dobutamine with the aim of achieving supranormal values (oxygen delivery index [DO2I] greater than 600 ml/min/m^2).
Intervention type
Drug
Phase
Not Specified
Drug names
Dobutamine
Primary outcome measure
To evaluate the effect of both DO2I optimisation with fluids compared to with fluids and dobutamine on 60-day mortality in high-risk general surgery patients.
Secondary outcome measures
The incidence of complications, particularly adverse cardiovascular events.
Overall trial start date
13/05/2002
Overall trial end date
31/05/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients older than 18 years old undergoing elective surgeries with greater than or equal to three points according to a risk scoring system adapted from the American College of Cardiology (ACC) or the American Heart Association (AHA) guidelines
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
98
Participant exclusion criteria
1. Refusal of consent
2. Haemodynamic instability prior to surgery
3. Congestive heart failure
4. Presence of infection
5. Acute myocardial ischaemia prior to enrolment
6. Life expectancy lower than 60 days
7. Disseminated malignancy
Recruitment start date
13/05/2002
Recruitment end date
31/05/2004
Locations
Countries of recruitment
Brazil
Trial participating centre
Av Faria Lima 5416
São Paulo
15091/000
Brazil
Funders
Funder type
Hospital/treatment centre
Funder name
Faculty of Medicine of Sao Jose do Rio Preto Foundation (Fundacao Faculdade de Medicina de Sao Jose do Rio Preto [FAMERP] - Hospital de Base) (Brazil)
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/16696864
Publication citations
-
Results
Lobo SM, Lobo FR, Polachini CA, Patini DS, Yamamoto AE, de Oliveira NE, Serrano P, Sanches HS, Spegiorin MA, Queiroz MM, Christiano AC, Savieiro EF, Alvarez PA, Teixeira SP, Cunrath GS, Prospective, randomized trial comparing fluids and dobutamine optimization of oxygen delivery in high-risk surgical patients [ISRCTN42445141]., Crit Care, 2006, 10, 3, R72, doi: 10.1186/cc4913.