Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2
Study information
Scientific title
Acronym
RxL
Study hypothesis
"Restrictive" strategy for fluid administration has been shown to improve outcomes in certain groups of surgical patients. Whether a "restrictive" strategy can be used safely in high-risk patients using dobutamine to optimise cardiac function is not known.
Ethics approval
Ethics approval received from the local ethics committee (Comite de Etica em pesquisa da Faculdade de Medicina de Sao Jose do Rio Preto) on the 20th January 2006 (ref: 4361/2005).
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Oxygen delivery in high-risk surgery
Intervention
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 and eight-hours post-operatively aiming to maximise DO2I to levels higher than 600 ml/min/m^2 using dobutamine and either "restrictive" (4 ml/kg/min) or "liberal" (12 ml/kg/min) strategies of intra-operative fluid management. Post-operatively both groups received 1.5 ml/kg/min of lactated ringer. Fluid challenge with 250 ml of colloid is given if there are signs of hypovolaemia.
Intervention type
Drug
Phase
Not Specified
Drug names
Dobutamine
Primary outcome measures
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 outcome measures
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).
Overall trial start date
20/02/2006
Overall trial end date
20/02/2008
Reason abandoned
Eligibility
Participant 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])
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
116 patients (58 in each group). First analysis on 50% of the patients enrolled.
Participant 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
Recruitment start date
20/02/2006
Recruitment end date
20/02/2008
Locations
Countries of recruitment
Brazil
Trial participating centre
Av Faria Lima 5544
São José do Rio Preto
15090-000
Brazil
Sponsor information
Organisation
Faculty of Medicine of Sao Jose do Rio Preto (FAMERP) Foundation (Brazil)
Sponsor details
Centro de Estudos e Pesquisa em Terapia Intensiva do Hospital de Base
c/o Professor Suzana Lobo
Av. Brigadeiro Faria Lima
5416 Vila Sao Pedro
Sao Jose do Rio Preto
Sao 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