Condition category
Surgery
Date applied
02/07/2007
Date assigned
27/09/2007
Last edited
27/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Suzana Lobo

ORCID ID

Contact details

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

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

http://www.famerp.br/

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

Publication citations

Additional files

Editorial Notes