Prospective, randomised trial comparing fluids and dobutamine optimisation of oxygen delivery in high-risk surgical patients
| ISRCTN | ISRCTN42445141 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42445141 |
| Secondary identifying numbers | 2611/2002 |
- Submission date
- 27/03/2006
- Registration date
- 30/03/2006
- Last edited
- 26/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Suzana Lobo
Scientific
Scientific
Av Faria Lima 5416
Jardim Universitário
São José do Rio Preto
São Paulo
15091/000
Brazil
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics board on the 13th May 2002 (ref: 2611/2002). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 13/05/2002 |
| Completion date | 31/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 98 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 13/05/2002 |
| Date of final enrolment | 31/05/2004 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Av Faria Lima 5416
São Paulo
15091/000
Brazil
15091/000
Brazil
Sponsor information
Faculty of Medicine of São José do Rio Preto (FAMERP) Foundation (Brazil)
Hospital/treatment centre
Hospital/treatment centre
Av. Brigadeiro Faria Lima, 5416
Vila São Pedro
São Paulo
15091/000
Brazil
"ROR" |
https://ror.org/052e6h087 |
|---|
Funders
Funder type
Hospital/treatment centre
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)
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? |
|---|---|---|---|---|---|
| Results article | Results | 01/07/2006 | Yes | No |
