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
Scientific
Av Faria Lima 5544
School of Medicine - Intensive Care
São José do Rio Preto
15090-000
Brazil
Study information
| Study design | Prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Dobutamine |
| Primary outcome measure | 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 study start date | 20/02/2006 |
| Completion date | 20/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 116 patients (58 in each group). First analysis on 50% of the patients enrolled. |
| 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
15090-000
Brazil
Sponsor information
Faculty of Medicine of Sao Jose do Rio Preto (FAMERP) Foundation (Brazil)
Hospital/treatment centre
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" |
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
