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Effects of "Restrictive" and "Liberal" strategies of intra-operative fluid management during optimisation of oxygen delivery in high-risk surgical patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN94984995
Enrollment
116
Registered
2007-09-27
Start date
2006-02-20
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

Oxygen delivery in high-risk surgery Surgery High risk surgery

Interventions

Lithium indicator dilution and pulse power analysis is used to measure cardiac output and to calculate Oxygen Delivery Index (DO2I) (LiDCO-plus system). A goal-directed therapy is used during surgery

Sponsors

Faculty of Medicine of Sao Jose do Rio Preto (FAMERP) Foundation (Brazil)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients 2. Either major surgery and one clinical predictor of risk or intermediate risk surgery and the association of two clinical predictors (scoring system adapted from Shoemaker criteria/American College of Cardiology [ACC]/American Heart Association [AHA])

Exclusion criteria

Exclusion criteria: 1. Emergency surgery 2. Acute myocardial ischaemia less than one month 3. Congestive heart failure (Functional Class IV New York Heart Association [NYHA]) 4. Chronic renal failure (pre-operative creatinine greater than 2.0 mg/dl or need for dialysis) 5. Patients on lithium therapy 6. Severe arrhythmia

Design outcomes

Primary

MeasureTime frame
Post-operative complications and hospital/Intensive Care Unit (ICU) length of stay. Primary and secondary outcomes will be measured during the first interim analysis planned that will probably be done in around 2 months (according to the number planned in the project).

Secondary

MeasureTime frame
1. Perfusion variables (serum lactate, central venous oxygen saturation) 2. Organ dysfunction Primary and secondary outcomes will be measured during the first interim analysis planned that will probably be done in around 2 months (according to the number planned in the project).

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026