Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT01424150
Eligibility 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
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01424150
Study Brief:
Protocol Section:
NCT01424150