Skip to content

Prospective, randomised trial comparing fluids and dobutamine optimisation of oxygen delivery in high-risk surgical patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN42445141
Enrollment
98
Registered
2006-03-30
Start date
2002-05-13
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk patients undergoing prolonged surgery Circulatory System High-risk surgical patients

Interventions

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

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
The incidence of complications, particularly adverse cardiovascular events.

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026