Restrictive versus liberal fluid therapy in major abdominal surgery (RELIEF): rationale and design for a multicentre randomised trial.
BMJ Open
; 7(3): e015358, 2017 03 03.
Article
en En
| MEDLINE
| ID: mdl-28259855
ABSTRACT
INTRODUCTION:
The optimal intravenous fluid regimen for patients undergoing major abdominal surgery is unclear. However, results from many small studies suggest a restrictive regimen may lead to better outcomes. A large, definitive clinical trial evaluating perioperative fluid replacement in major abdominal surgery, therefore, is required. METHODS/ANALYSIS:
We designed a pragmatic, multicentre, randomised, controlled trial (the RELIEF trial). A total of 3000 patients were enrolled in this study and randomly allocated to a restrictive or liberal fluid regimen in a 11 ratio, stratified by centre and planned critical care admission. The expected fluid volumes in the first 24â hour from the start of surgery in restrictive and liberal groups were ≤3.0â L and ≥5.4â L, respectively. Patient enrolment is complete, and follow-up for the primary end point is ongoing. The primary outcome is disability-free survival at 1â year after surgery, with disability defined as a persistent (at least 6â months) reduction in functional status using the 12-item version of the World Health Organisation Disability Assessment Schedule. ETHICS/DISSEMINATION The RELIEF trial has been approved by the responsible ethics committees of all participating sites. Participant recruitment began in March 2013 and was completed in August 2016, and 1-year follow-up will conclude in August 2017. Publication of the results of the RELIEF trial is anticipated in early 2018. TRIAL REGISTRATION NUMBER ClinicalTrials.gov identifier NCT01424150.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Complicaciones Posoperatorias
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Proyectos de Investigación
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Abdomen
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Fluidoterapia
Tipo de estudio:
Clinical_trials
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Prognostic_studies
Límite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Año:
2017
Tipo del documento:
Article