Colorectal Disorders
Conditions
Keywords
colorectal surgery, volume status
Brief summary
The purpose of this study is to find out if giving a medicine called furosemide, which is a diuretic or water pill, after colon surgery will safely shorten the patient's length of hospital stay.
Detailed description
This study will assess if administration of a loop diuretic, specifically furosemide, to achieve euvolemia can safely reduce length of stay following colorectal surgery.
Interventions
DRUGFurosemide
DRUGCelecoxib
Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation.
DRUGGabapentin
Gabapentin is a oral drug used to treat seizures, postherpetic neuralgia, and restless legs syndrome.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All elective colorectal surgeries (CRS) utilizing the enhanced recovery pathway (ERP) * The surgery involves resection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | Up to 7 days | Participants will be followed for the duration of hospital stay, an expected average of 2-7 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Readmitted to Mayo Clinic Within 30-days | Within 30 days of release from hospital | — |
| Number of Participants Requiring Nasogastric Tube Placement | Up to 7 days | — |
| Time to Stool Output | Up to 4 days | — |
| Number of Participants With Acute Kidney Injury | Up to 7 days | Acute kidney injury (AKI) refers to an abrupt decrease in kidney function, resulting in the retention of urea and other nitrogenous waste products and in the dysregulation of extracellular volume and electrolytes. The term AKI has largely replaced acute renal failure (ARF), reflecting the recognition that smaller decrements in kidney function that do not result in overt organ failure are of substantial clinical relevance and are associated with increased morbidity and mortality. The AKI experienced by these patients was not considered an adverse event. |
| Number of Participants With Hypokalemia | Up to 7 days | Hypokalemia is generally defined as a serum potassium level of less than 3.5 mmol/L. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled at Mayo Clinic in Rochester, Minnesota between February 2015 and April 2016.
Participants by arm
| Arm | Count |
|---|---|
| Furosemide + Enhanced Recovery After Surgery (ERAS) Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm. | 62 |
| Enhanced Recovery After Surgery (ERAS) ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale. | 61 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Allocation | Acute Kidney Injury on Post Op Day 1 | 1 | 0 |
| Allocation | Hypotension preventing administration | 2 | 0 |
| Allocation | POD weight<pre-op weight | 3 | 0 |
| Follow-Up | 1 ERAS Component Noncompliant | 0 | 6 |
| Follow-Up | 2 ERAS Components Noncompliant | 0 | 4 |
| Follow-Up | Acute Kidney Injury | 1 | 0 |
| Follow-Up | Early dismissal | 3 | 0 |
| Follow-Up | Hypotension | 3 | 0 |
| Follow-Up | No documentation | 2 | 0 |
| Follow-Up | POD weight<pre-op weight | 3 | 0 |
Baseline characteristics
| Characteristic | Furosemide + Enhanced Recovery After Surgery (ERAS) | Enhanced Recovery After Surgery (ERAS) | Total |
|---|---|---|---|
| Age, Continuous | 57 years | 61 years | 59 years |
| Region of Enrollment United States | 62 Participants | 61 Participants | 123 Participants |
| Sex: Female, Male Female | 22 Participants | 28 Participants | 50 Participants |
| Sex: Female, Male Male | 40 Participants | 33 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 61 |
| other Total, other adverse events | 8 / 62 | 3 / 61 |
| serious Total, serious adverse events | 0 / 62 | 0 / 61 |
Outcome results
Primary
Length of Hospital Stay
Participants will be followed for the duration of hospital stay, an expected average of 2-7 days.
Time frame: Up to 7 days
Population: Intent to treat analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Furosemide + Enhanced Recovery After Surgery (ERAS) | Length of Hospital Stay | 99.6 hours |
| Enhanced Recovery After Surgery (ERAS) | Length of Hospital Stay | 80.6 hours |
Comparison: Significance level of 0.05 was used.p-value: 0.564Wilcoxon (Mann-Whitney)
Secondary
Number of Participants Readmitted to Mayo Clinic Within 30-days
Time frame: Within 30 days of release from hospital
Population: Intention to treat analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Furosemide + Enhanced Recovery After Surgery (ERAS) | Number of Participants Readmitted to Mayo Clinic Within 30-days | 13 Participants |
| Enhanced Recovery After Surgery (ERAS) | Number of Participants Readmitted to Mayo Clinic Within 30-days | 10 Participants |
Comparison: Significance level of 0.05 was used.p-value: 0.675Wilcoxon (Mann-Whitney)
Secondary
Number of Participants Requiring Nasogastric Tube Placement
Time frame: Up to 7 days
Population: Intention to Treat Analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Furosemide + Enhanced Recovery After Surgery (ERAS) | Number of Participants Requiring Nasogastric Tube Placement | 6 Participants |
| Enhanced Recovery After Surgery (ERAS) | Number of Participants Requiring Nasogastric Tube Placement | 1 Participants |
Comparison: Significance level of 0.05 was used.p-value: 0.125Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With Acute Kidney Injury
Acute kidney injury (AKI) refers to an abrupt decrease in kidney function, resulting in the retention of urea and other nitrogenous waste products and in the dysregulation of extracellular volume and electrolytes. The term AKI has largely replaced acute renal failure (ARF), reflecting the recognition that smaller decrements in kidney function that do not result in overt organ failure are of substantial clinical relevance and are associated with increased morbidity and mortality. The AKI experienced by these patients was not considered an adverse event.
Time frame: Up to 7 days
Population: Intention to treat analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Furosemide + Enhanced Recovery After Surgery (ERAS) | Number of Participants With Acute Kidney Injury | 2 Participants |
| Enhanced Recovery After Surgery (ERAS) | Number of Participants With Acute Kidney Injury | 2 Participants |
Comparison: Significance level of 0.05 was used.p-value: 0.595Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With Hypokalemia
Hypokalemia is generally defined as a serum potassium level of less than 3.5 mmol/L.
Time frame: Up to 7 days
Population: Intention to treat analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Furosemide + Enhanced Recovery After Surgery (ERAS) | Number of Participants With Hypokalemia | 2 Participants |
| Enhanced Recovery After Surgery (ERAS) | Number of Participants With Hypokalemia | 3 Participants |
Comparison: Significance level of 0.05 was used.p-value: 0.985Wilcoxon (Mann-Whitney)
Secondary
Time to Stool Output
Time frame: Up to 4 days
Population: Intention to treat analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Furosemide + Enhanced Recovery After Surgery (ERAS) | Time to Stool Output | 48.8 hours |
| Enhanced Recovery After Surgery (ERAS) | Time to Stool Output | 45.4 hours |