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
Protocol serial number	2
Sponsor	Faculty of Medicine of Sao Jose do Rio Preto (FAMERP) Foundation (Brazil)
Funder	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)

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

Primary study design	Interventional
Study design	Prospective randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Effects of "Restrictive" and "Liberal" strategies of intra-operative fluid management during optimisation of oxygen delivery in high-risk surgical patients
Study acronym	RxL
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) studied	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 / device / biological / vaccine name(s)	Dobutamine
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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).
Completion date	20/02/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	116
Total final enrolment	88
Key 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])
Key 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
Date of first enrolment	20/02/2006
Date of final enrolment	20/02/2008

Locations

Countries of recruitment

Brazil

Study participating centre

Av Faria Lima 5544

São José do Rio Preto
15090-000
Brazil

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/09/2011	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.