Less fluid during surgery may lead to better recovery
NCT ID NCT01424150
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at whether giving less fluid during major abdominal surgery helps patients recover better than giving more fluid. Over 3,000 adults having elective abdominal surgery were randomly assigned to either a restrictive (less than 2 liters per day) or liberal (about 6 liters per day) fluid plan. The main goal was to see which group had better disability-free survival up to one year after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- intravenous fluids (restrictive vs liberal protocol)
- What this could lead to
- If successful, this could establish a standard for how much fluid to give during major abdominal surgery, potentially reducing complications and improving recovery.
- What could go wrong
- This is a completed trial, so results are already known. However, the optimal fluid strategy may still depend on individual patient factors and surgical context, limiting broad applicability.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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3,000 people
The number who actually took part.
- Started
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Jul 2013
- Finished
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Oct 2017
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Alfred Hospital
Melbourne, Victoria, 3004, Australia
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