Condition category
Circulatory System
Date applied
27/03/2006
Date assigned
30/03/2006
Last edited
26/03/2008
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 Suzana Lobo

ORCID ID

Contact details

Av Faria Lima 5416
Jardim Universitário
São José do Rio Preto
São Paulo
15091/000
Brazil

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 measures

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

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

Sponsor information

Organisation

Faculty of Medicine of São José do Rio Preto (FAMERP) Foundation (Brazil)

Sponsor details

Av. Brigadeiro Faria Lima
5416
Vila São Pedro
São Paulo
15091/000
Brazil

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/16696864

Publication citations

  1. 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.

Additional files

Editorial Notes