REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02073162

13-1287

Ages > 18
All Genders

Study 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)

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 expectedduration of at least 2 hours, and an expected hospital stay of at least 3 days (forexample, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic oraorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radicalhysterectomy, and abdominal incisional hernia repair)
at increased risk of postoperative complications, defined as at least one of thefollowing 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

Exclusion Criteria:

urgent or time-critical surgery
ASA physical status 5 - such patients are not expected to survive with or withoutsurgery, and their underlying illness is expected to have an overwhelming effect onoutcome (irrespective of fluid therapy)
chronic renal failure requiring dialysis
pulmonary or cardiac surgery - different pathophysiology, and thoracic surgerytypically have strict fluid restrictions
liver resection - most units have strict fluid/CVP limits in place and won't allowrandomisation
minor or intermediate surgery, such as laparoscopic cholecystectomy, transurethralresection 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

February 01, 2014

February 28, 2018

Connect with a study center

Cleveland Clinic
Cleveland, Ohio 44195
United States
Site Not Available

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