REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Cleveland Clinic
- Enrollment
- 3,000
- Locations
- 2
- Primary Endpoint
- Number of Participants With Disability-free Survival
Study Overview
Brief Summary
Physicians differ in their approaches to surgical fluid therapy, with some preferring higher volumes and others lower volumes. Each approach has potential advantages and disadvantages. Currently, there is no compelling evidence that one approach is better than the other. This study tests whether giving a volume on the low end of the usual amount ("restrictive management") has a different rate of complications compared to a volume on the high end of the usual amount ("liberal management"). This study will compare liberal and restrictive fluid management to determine their effects on major complications after abdominal surgery.
Those who take part in the study will be visited five times before and after surgery in the hospital. Once discharged from the hospital, participants will be called 4 times on the telephone.
Preadmission Clinic/Preoperative Visit
- Sign the consent document
- Have blood drawn for standard preoperative tests (standard of care)
- Have an electrocardiogram (standard of care)
- Complete a questionnaire on disability (research)
Day of Surgery
- Have blood drawn if not already done during the first visit (standard of care)
- Have an electrocardiogram if not already done during the first visit (standard of care)
- Be randomly assigned to either restrictive or liberal fluid management (research)
Post-op Day 1
- Have an electrocardiogram done (research)
- Have blood drawn for standard tests (standard of care)
- Have a wound inspection, if there is a change of dressing (standard of care)
- Complete a questionnaire about your recovery (research)
Post-op Day 3
- Have blood drawn for standard tests (standard of care) and c-reactive protein, which can indicate infection (for research).
- Have a wound inspection, if there is a change of dressing (standard of care)
- Complete a questionnaire about your recovery (research)
Day of Discharge
- Have a wound inspection, if there is a change of dressing (standard of care)
30-Day Follow-up Phone Call
- Complete a questionnaire about your recovery (research)
- Complete a questionnaire about disability (research)
3 Month, 6-Month, and 12-Month Follow-up Phone Calls
- Complete a questionnaire about disability (research)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Liberal group
At induction-Hartmanns 10 ml/kg During surgery-Hartmanns 8 ml/kg/h After surgery-IV fluids ≥1.5 ml/kg/h Continue IV fluids ≥24hrs
Intervention: Major Abdominal Surgery (Procedure)
Restrictive group
At induction-Hartmanns ≤5 ml/kg During surgery-Hartmanns 5 ml/kg/h After surgery-IV fluids, ≤0.8 ml/kg/h Cease IV fluids ASAP,aim for early oral fluids
Intervention: Major Abdominal Surgery (Procedure)
Outcomes
Primary Outcomes
Number of Participants With Disability-free Survival
Time Frame: 1 year
Disability was defined as a persistent impairment in health status (lasting ≥6 months), as measured by a score of at least 24 points on the WHODAS questionnaire, which reflects a disability level of at least 25% (the threshold point between "disabled" and "not disabled").
Secondary Outcomes
- Death(12 month)
- Number of Participants With a Composite of Mortality or Major Septic Complications(30-day)
- Number of Participants With Anastomotic Leak(Indexed hospital stay)
- Number of Participants With Pulmonary Edema(Indexed hospital stay)
- Number of Participants With Surgical-site Infection(Indexed hospital stay)
- Number of Participants With Unplanned Admission to ICU(30 day)
- Number of Participants With Pneumonia(Indexed hospital stay)
- Number of Participants With Acute Kidney Injury(90 days)
- Number of Participants Undergoing Renal-replacement Therapy(Indexed hospital stay)
- Number of Participants With Sepsis(Indexed hospital stay)