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

ISRCTN ISRCTN94984995
DOI https://doi.org/10.1186/ISRCTN94984995
Secondary identifying numbers 2
Submission date
02/07/2007
Registration date
27/09/2007
Last edited
31/12/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
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

Av Faria Lima 5544
School of Medicine - Intensive Care
São José do Rio Preto
15090-000
Brazil

Study information

Study designProspective randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleEffects of "Restrictive" and "Liberal" strategies of intra-operative fluid management during optimisation of oxygen delivery in high-risk surgical patients
Study acronymRxL
Study objectives"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(s)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).
Health condition(s) or problem(s) studiedOxygen delivery in high-risk surgery
InterventionLithium 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Dobutamine
Primary outcome measurePost-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 measures1. 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 study start date20/02/2006
Completion date20/02/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants116 patients (58 in each group). First analysis on 50% of the patients enrolled.
Total final enrolment88
Key inclusion criteria1. 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])
Key exclusion criteria1. 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
Date of first enrolment20/02/2006
Date of final enrolment20/02/2008

Locations

Countries of recruitment

  • Brazil

Study participating centre

Av Faria Lima 5544
São José do Rio Preto
15090-000
Brazil

Sponsor information

Faculty of Medicine of Sao Jose do Rio Preto (FAMERP) Foundation (Brazil)
Hospital/treatment centre

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

Website http://www.famerp.br/
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2011 31/12/2020 Yes No

Editorial Notes

31/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.