Major Abdominal Surgery
Conditions
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)
Interventions
PROCEDUREMajor Abdominal Surgery
•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)
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Disability-free Survival | 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
| Measure | Time frame |
|---|---|
| Number of Participants With a Composite of Mortality or Major Septic Complications | 30-day |
| Number of Participants With Surgical-site Infection | Indexed hospital stay |
| Number of Participants With Sepsis | Indexed hospital stay |
| Number of Participants With Anastomotic Leak | 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 Pulmonary Edema | Indexed hospital stay |
| Number of Participants With Unplanned Admission to ICU | 30 day |
| Death | 90 days |
| Number of Participants With Pneumonia | Indexed hospital stay |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
Major Abdominal Surgery: •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) | 1,493 |
| 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
Major Abdominal Surgery: •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) | 1,490 |
| Total | 2,983 |
Baseline characteristics
| Characteristic | Liberal Group | Total | Restrictive Group |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 13 | 66 years STANDARD_DEVIATION 13 | 66 years STANDARD_DEVIATION 13 |
| ASA Physical Status Classification ASA I | 21 Participants | 46 Participants | 25 Participants |
| ASA Physical Status Classification ASA II | 540 Participants | 1082 Participants | 542 Participants |
| ASA Physical Status Classification ASA III | 868 Participants | 1717 Participants | 849 Participants |
| ASA Physical Status Classification ASA IV | 64 Participants | 138 Participants | 74 Participants |
| Body Weight | 83 kg | 83 kg | 84 kg |
| Chronic obstructive pulmonary disease | 254 Participants | 498 Participants | 244 Participants |
| Coronary artery disease | 250 Participants | 462 Participants | 212 Participants |
| Current smoker | 204 Participants | 398 Participants | 194 Participants |
| CVP monitoring | 272 Participants | 548 Participants | 276 Participants |
| Duration of Surgery | 3.3 hr | 3.3 hr | 3.3 hr |
| Heart failure | 47 Participants | 104 Participants | 57 Participants |
| History of stroke or TIA | 115 Participants | 220 Participants | 105 Participants |
| Hypertension | 908 Participants | 1807 Participants | 899 Participants |
| Invasive blood-pressure monitoring | 1080 Participants | 2150 Participants | 1070 Participants |
| Median preoperative WHODAS score | 15 units on a scale | 15 units on a scale | 15 units on a scale |
| Moderate or severe renal disease | 108 Participants | 209 Participants | 101 Participants |
| Neuraxial block | 358 Participants | 767 Participants | 409 Participants |
| Peripheral vascular disease | 92 Participants | 187 Participants | 95 Participants |
| Planned postoperative care in HDU or ICU | 418 Participants | 834 Participants | 416 Participants |
| Previous myocardial infarction | 146 Participants | 268 Participants | 122 Participants |
| Region of Enrollment Australia | 841 Participants | 1677 Participants | 836 Participants |
| Region of Enrollment Canada | 247 Participants | 497 Participants | 250 Participants |
| Region of Enrollment Hong Kong | 116 Participants | 227 Participants | 111 Participants |
| Region of Enrollment Italy | 32 Participants | 64 Participants | 32 Participants |
| Region of Enrollment New Zealand | 48 Participants | 94 Participants | 46 Participants |
| Region of Enrollment United Kingdom | 134 Participants | 275 Participants | 141 Participants |
| Region of Enrollment United States | 75 Participants | 149 Participants | 74 Participants |
| Sex: Female, Male Female | 710 Participants | 1429 Participants | 719 Participants |
| Sex: Female, Male Male | 783 Participants | 1554 Participants | 771 Participants |
| Surgical method Laparoscopic | 463 Participants | 921 Participants | 458 Participants |
| Surgical method Laparoscopic-assisted | 242 Participants | 456 Participants | 214 Participants |
| Surgical method Open | 788 Participants | 1606 Participants | 818 Participants |
| Type of Surgery Colorectal | 651 Participants | 1297 Participants | 646 Participants |
| Type of Surgery Esophageal or gastric | 257 Participants | 543 Participants | 286 Participants |
| Type of Surgery Gynecologic | 139 Participants | 274 Participants | 135 Participants |
| Type of Surgery Hepatobiliary | 139 Participants | 272 Participants | 133 Participants |
| Type of Surgery Other | 84 Participants | 154 Participants | 70 Participants |
| Type of Surgery Urologic or renal | 223 Participants | 443 Participants | 220 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 205 / 1,493 | 208 / 1,490 |
| serious Total, serious adverse events | 103 / 1,493 | 118 / 1,490 |
Outcome results
Primary
Number of Participants With Disability-free Survival
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).
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Group | Number of Participants With Disability-free Survival | 1232 Participants |
| Restrictive Group | Number of Participants With Disability-free Survival | 1223 Participants |
Secondary
Death
Time frame: 12 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Group | Death | 96 Participants |
| Restrictive Group | Death | 95 Participants |
Secondary
Death
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Group | Death | 18 Participants |
| Restrictive Group | Death | 31 Participants |
Secondary
Number of Participants Undergoing Renal-replacement Therapy
Time frame: Indexed hospital stay
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Group | Number of Participants Undergoing Renal-replacement Therapy | 4 Participants |
| Restrictive Group | Number of Participants Undergoing Renal-replacement Therapy | 13 Participants |
Secondary
Number of Participants With a Composite of Mortality or Major Septic Complications
Time frame: 30-day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Group | Number of Participants With a Composite of Mortality or Major Septic Complications | 195 Participants |
| Restrictive Group | Number of Participants With a Composite of Mortality or Major Septic Complications | 323 Participants |
Secondary
Number of Participants With Acute Kidney Injury
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Group | Number of Participants With Acute Kidney Injury | 72 Participants |
| Restrictive Group | Number of Participants With Acute Kidney Injury | 124 Participants |
Secondary
Number of Participants With Anastomotic Leak
Time frame: Indexed hospital stay
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Group | Number of Participants With Anastomotic Leak | 35 Participants |
| Restrictive Group | Number of Participants With Anastomotic Leak | 49 Participants |
Secondary
Number of Participants With Pneumonia
Time frame: Indexed hospital stay
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Group | Number of Participants With Pneumonia | 57 Participants |
| Restrictive Group | Number of Participants With Pneumonia | 54 Participants |
Secondary
Number of Participants With Pulmonary Edema
Time frame: Indexed hospital stay
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Group | Number of Participants With Pulmonary Edema | 32 Participants |
| Restrictive Group | Number of Participants With Pulmonary Edema | 20 Participants |
Secondary
Number of Participants With Sepsis
Time frame: Indexed hospital stay
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Group | Number of Participants With Sepsis | 129 Participants |
| Restrictive Group | Number of Participants With Sepsis | 157 Participants |
Secondary
Number of Participants With Surgical-site Infection
Time frame: Indexed hospital stay
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Group | Number of Participants With Surgical-site Infection | 202 Participants |
| Restrictive Group | Number of Participants With Surgical-site Infection | 245 Participants |
Secondary
Number of Participants With Unplanned Admission to ICU
Time frame: 30 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Group | Number of Participants With Unplanned Admission to ICU | 145 Participants |
| Restrictive Group | Number of Participants With Unplanned Admission to ICU | 161 Participants |