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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
Day of Surgery
Post-op Day 1
Post-op Day 3
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liberal group | Active Comparator | 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 |
|
| Restrictive group | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Major Abdominal Surgery | Procedure | •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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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"). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute Kidney Injury | 90 days | |
| Number of Participants With a Composite of Mortality or Major Septic Complications | 30-day | |
| Number of Participants With Surgical-site Infection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Kurz | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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"). | Posted | Count of Participants | Participants | 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Sessler | The Cleveland Clinic Foundation | 216-444-4900 | ds@or.org |
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|
| Indexed hospital stay |
| Number of Participants With Sepsis | Indexed hospital stay |
| Number of Participants With Anastomotic Leak | Indexed hospital stay |
| Number of Participants With Pneumonia | Indexed hospital stay |
| 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 |
| Death | 12 month |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Weight | Median | Inter-Quartile Range | kg |
|
| ASA Physical Status Classification | ASA I: A normal healthy patient ASA II: A patient with mild systemic disease ASA III: A patient with severe systemic disease ASA IV: A patient with severe systemic disease that is a constant threat to life | Count of Participants | Participants |
|
| Median preoperative WHODAS score | World Health Organization Disability Assessment Schedule (12 item) estimates the amount of disability. Each of the item in the questionnaire scores from 0 (No difficulty) to 4 (Extreme Difficulty or Cannot Do). The total score summed over the 12 items for the whole questionnaire ranges from 0 to 48, with the score of 24 or greater indicating at least moderate disability. | Median | Inter-Quartile Range | units on a scale |
|
| Hypertension | Count of Participants | Participants |
|
| Coronary artery disease | Count of Participants | Participants |
|
| Heart failure | Count of Participants | Participants |
|
| Previous myocardial infarction | Count of Participants | Participants |
|
| Peripheral vascular disease | Count of Participants | Participants |
|
| Current smoker | Count of Participants | Participants |
|
| History of stroke or TIA | Count of Participants | Participants |
|
| Chronic obstructive pulmonary disease | Count of Participants | Participants |
|
| Moderate or severe renal disease | Count of Participants | Participants |
|
| Neuraxial block | Count of Participants | Participants |
|
| Invasive blood-pressure monitoring | Count of Participants | Participants |
|
| CVP monitoring | Count of Participants | Participants |
|
| Type of Surgery | Count of Participants | Participants |
|
| Surgical method | Count of Participants | Participants |
|
| Duration of Surgery | Median | Inter-Quartile Range | hr |
|
| Planned postoperative care in HDU or ICU | Count of Participants | Participants |
|
| OG001 | 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) |
|
|
| Secondary | Number of Participants With Acute Kidney Injury | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Number of Participants With a Composite of Mortality or Major Septic Complications | Posted | Count of Participants | Participants | 30-day |
|
|
|
| Secondary | Number of Participants With Surgical-site Infection | Posted | Count of Participants | Participants | Indexed hospital stay |
|
|
|
| Secondary | Number of Participants With Sepsis | Posted | Count of Participants | Participants | Indexed hospital stay |
|
|
|
| Secondary | Number of Participants With Anastomotic Leak | Posted | Count of Participants | Participants | Indexed hospital stay |
|
|
|
| Secondary | Number of Participants With Pneumonia | Posted | Count of Participants | Participants | Indexed hospital stay |
|
|
|
| Secondary | Number of Participants Undergoing Renal-replacement Therapy | Posted | Count of Participants | Participants | Indexed hospital stay |
|
|
|
| Secondary | Number of Participants With Pulmonary Edema | Posted | Count of Participants | Participants | Indexed hospital stay |
|
|
|
| Secondary | Number of Participants With Unplanned Admission to ICU | Posted | Count of Participants | Participants | 30 day |
|
|
|
| Secondary | Death | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Death | Posted | Count of Participants | Participants | 12 month |
|
|
|
| 103 |
| 1,493 |
| 205 |
| 1,493 |
| EG001 | 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) | 118 | 1,490 | 208 | 1,490 |
| Stroke | Vascular disorders | Systematic Assessment |
|
| Other cardiovascular | Cardiac disorders | Systematic Assessment |
|
| Thromboembolish | Vascular disorders | Systematic Assessment |
|
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