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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01424150




Registration number
NCT01424150
Ethics application status
Date submitted
25/08/2011
Date registered
26/08/2011

Titles & IDs
Public title
REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery: RELIEF Study
Scientific title
Restrictive Versus Liberal Fluid Therapy in Major Abdominal Surgery
Secondary ID [1] 0 0
164/11 Pilot - 544/12 Main
Universal Trial Number (UTN)
Trial acronym
RELIEF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal Surgery 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Liberal fluid therapy
Other interventions - Restrictive fluid therapy

Experimental: Liberal - At the commencement of surgery a bolus of Hartmann's balanced salt crystalloid 10 ml/kg followed by 8 ml/kg/h will be administered until the end of surgery. A maintenance infusion will then continue at 1.5 ml/kg/h, for at least 24 hours, but this can be reduced postoperatively if there is evidence of fluid overload and no hypotension, and increased if there is evidence of hypovolaemia or hypotension. Alternative fluid types (crystalloid, dextrose, colloid) and electrolyte supplements will be allowed postoperatively in order to account for local preferences and patient biochemistry, for which we will collect data.

Experimental: Restrictive - Will provide less than 2.0 L water and 120 mmol sodium per day. Induction of anaesthesia will limit IV bolus fluid to =5 ml/kg; no other IV fluids will be used at the commencement of surgery (unless indicated by goal-directed device \[see below\]). Hartmann's balanced salt crystalloid 5 ml/kg/h will be administered until the end of surgery, and bolus colloid/blood used intraoperatively to replace blood loss (ml for ml); then an infusion at 1 ml/kg/h until expedited cessation of IV fluid therapy within 24 hours. The rate of postoperative fluid replacement can be reduced if there is evidence of fluid overload and no hypotension, and can be increased if there is hypotension AND evidence of hypovolaemia.


Other interventions: Liberal fluid therapy
Liberal protocol group is designed to provide approximately 6.0L per day.

Other interventions: Restrictive fluid therapy
Restrictive protocol group is designed to provide less than 2.0 L water and 120 mmol sodium per day.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disability-free survival
Timepoint [1] 0 0
1 year postoperative
Secondary outcome [1] 0 0
Death
Timepoint [1] 0 0
90 days, then up to 12 months after surgery
Secondary outcome [2] 0 0
A composite (pooled) and individual septic complications: sepsis, surgical site infection, anastomotic leak, and pneumonia
Timepoint [2] 0 0
30 days postoperative
Secondary outcome [3] 0 0
Sepsis
Timepoint [3] 0 0
30 days postoperative
Secondary outcome [4] 0 0
Surgical site infection
Timepoint [4] 0 0
30 days postoperative
Secondary outcome [5] 0 0
Pneumonia
Timepoint [5] 0 0
30 Days postoperative
Secondary outcome [6] 0 0
Acute kidney injury
Timepoint [6] 0 0
30 days postoperative
Secondary outcome [7] 0 0
Pulmonary oedema
Timepoint [7] 0 0
30 days postoperative
Secondary outcome [8] 0 0
Total ICU stay and mechanical ventilation time
Timepoint [8] 0 0
30 day postoperative
Secondary outcome [9] 0 0
Hospital stay
Timepoint [9] 0 0
30 days postoperative
Secondary outcome [10] 0 0
Quality of recovery
Timepoint [10] 0 0
days 1, 3 and day 30 postoperative
Secondary outcome [11] 0 0
Anastomotic leak
Timepoint [11] 0 0
30 days postoperative
Secondary outcome [12] 0 0
Inflammation
Timepoint [12] 0 0
Day 3 postoperative
Secondary outcome [13] 0 0
Tissue perfusion
Timepoint [13] 0 0
24 hours post surgery
Secondary outcome [14] 0 0
Any blood transfusion
Timepoint [14] 0 0
From surgery to Day 3 postoperative
Secondary outcome [15] 0 0
Total ICU stay and unplanned ICU admission to ICU
Timepoint [15] 0 0
30 days postoperative

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Adults (=18 years) undergoing elective major surgery and providing informed consent
2. 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)
3. 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. Urgent or time-critical surgery
2. 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)
3. Chronic renal failure requiring dialysis
4. Pulmonary or cardiac surgery - different pathophysiology, and thoracic surgery typically have strict fluid restrictions
5. Liver resection - most units have strict fluid/CVP limits in place and won't allow randomisation
6. 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/10/2017
Sample size
Target
Accrual to date
Final
3000
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul S Myles, MB.BS, MPH, MD, FANZCA
Address 0 0
Alfred Hospital, Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01424150