Status:
COMPLETED
REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery: RELIEF Study
Lead Sponsor:
Bayside Health
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Conditions:
Abdominal Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The optimal fluid regimen, haemodynamic (or other) targets and fluid choice (colloid or crystalloid) for patients undergoing major surgery are based on rationales that are not supported by strong evid...
Detailed Description
The investigators have completed a pilot study of 82 subjects to test the feasibility of the trial (2011), and are currently doing a cost-effectiveness substudy (2012-13) 1\. AIM OF THE TRIAL To inve...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Adults (≥18 years) undergoing elective major surgery and providing informed consent
- All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
- At increased risk of postoperative complications, defined as at least one of the following criteria:
- age ≥70 years
- known or documented history of coronary artery disease
- known or documented history of heart failure
- diabetes currently treated with an oral hypoglycaemic agent and/or insulin
- preoperative serum creatinine \>200 µmol/L (\>2.8 mg/dl)
- morbid obesity (BMI ≥35 kg/m²)
- preoperative serum albumin \<30 g/L
- anaerobic threshold (if done) \<12 mL/kg/min
- or two or more of the following risk factors:
- ASA 3 or 4
- chronic respiratory disease
- obesity (BMI 30-35 kg/m²)
- aortic or peripheral vascular disease
- preoperative haemoglobin \<100 g/L
- preoperative serum creatinine 150-199 µmol/L (\>1.7 mg/dl)
- anaerobic threshold (if done) 12-14 mL/kg/min
- Exclusion Criteria
- Urgent or time-critical surgery
- ASA physical status 5 - such patients are not expected to survive with or without surgery, and their underlying illness is expected to have an overwhelming effect on outcome (irrespective of fluid therapy)
- Chronic renal failure requiring dialysis
- Pulmonary or cardiac surgery - different pathophysiology, and thoracic surgery typically have strict fluid restrictions
- Liver resection - most units have strict fluid/CVP limits in place and won't allow randomisation
- Minor or intermediate surgery, such as laparoscopic cholecystectomy, transurethral resection of the prostate, inguinal hernia repair, splenectomy, closure of colostomy - each of these are typically "minor" surgery with minimal IV fluid requirements, generally low rates of complications and mostly very good survival.
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2017
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT01424150
Start Date
July 1 2013
End Date
October 22 2017
Last Update
January 24 2025
Active Locations (1)
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1
Alfred Hospital
Melbourne, Victoria, Australia, 3004