Trial Outcomes & Findings for Early Diuresis Following Colorectal Surgery (NCT NCT02351934)
NCT ID: NCT02351934
Last Updated: 2018-05-07
Results Overview
Participants will be followed for the duration of hospital stay, an expected average of 2-7 days.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
123 participants
Primary outcome timeframe
Up to 7 days
Results posted on
2018-05-07
Participant Flow
Subjects were enrolled at Mayo Clinic in Rochester, Minnesota between February 2015 and April 2016.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Allocation
STARTED
|
62
|
61
|
|
Allocation
Received Allocation
|
56
|
61
|
|
Allocation
COMPLETED
|
56
|
61
|
|
Allocation
NOT COMPLETED
|
6
|
0
|
|
Follow-Up
STARTED
|
56
|
61
|
|
Follow-Up
COMPLETED
|
44
|
51
|
|
Follow-Up
NOT COMPLETED
|
12
|
10
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Allocation
POD weight<pre-op weight
|
3
|
0
|
|
Allocation
Hypotension preventing administration
|
2
|
0
|
|
Allocation
Acute Kidney Injury on Post Op Day 1
|
1
|
0
|
|
Follow-Up
POD weight<pre-op weight
|
3
|
0
|
|
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
1 ERAS Component Noncompliant
|
0
|
6
|
|
Follow-Up
2 ERAS Components Noncompliant
|
0
|
4
|
Baseline Characteristics
Early Diuresis Following Colorectal Surgery
Baseline characteristics by cohort
| Measure |
Furosemide + Enhanced Recovery After Surgery (ERAS)
n=62 Participants
Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
|
Enhanced Recovery After Surgery (ERAS)
n=61 Participants
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.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
61 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
62 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 7 daysPopulation: Intent to treat analysis
Participants will be followed for the duration of hospital stay, an expected average of 2-7 days.
Outcome measures
| Measure |
Furosemide + Enhanced Recovery After Surgery (ERAS)
n=62 Participants
Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
|
Enhanced Recovery After Surgery (ERAS)
n=61 Participants
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.
|
|---|---|---|
|
Length of Hospital Stay
|
99.6 hours
Interval 73.1 to 150.6
|
80.6 hours
Interval 73.6 to 124.0
|
SECONDARY outcome
Timeframe: Within 30 days of release from hospitalPopulation: Intention to treat analysis
Outcome measures
| Measure |
Furosemide + Enhanced Recovery After Surgery (ERAS)
n=62 Participants
Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
|
Enhanced Recovery After Surgery (ERAS)
n=61 Participants
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.
|
|---|---|---|
|
Number of Participants Readmitted to Mayo Clinic Within 30-days
|
13 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 7 daysPopulation: Intention to Treat Analysis
Outcome measures
| Measure |
Furosemide + Enhanced Recovery After Surgery (ERAS)
n=62 Participants
Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
|
Enhanced Recovery After Surgery (ERAS)
n=61 Participants
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.
|
|---|---|---|
|
Number of Participants Requiring Nasogastric Tube Placement
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 4 daysPopulation: Intention to treat analysis
Outcome measures
| Measure |
Furosemide + Enhanced Recovery After Surgery (ERAS)
n=62 Participants
Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
|
Enhanced Recovery After Surgery (ERAS)
n=61 Participants
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.
|
|---|---|---|
|
Time to Stool Output
|
48.8 hours
Interval 27.8 to 82.2
|
45.4 hours
Interval 22.7 to 68.8
|
SECONDARY outcome
Timeframe: Up to 7 daysPopulation: Intention to treat analysis
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.
Outcome measures
| Measure |
Furosemide + Enhanced Recovery After Surgery (ERAS)
n=62 Participants
Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
|
Enhanced Recovery After Surgery (ERAS)
n=61 Participants
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.
|
|---|---|---|
|
Number of Participants With Acute Kidney Injury
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 7 daysPopulation: Intention to treat analysis
Hypokalemia is generally defined as a serum potassium level of less than 3.5 mmol/L.
Outcome measures
| Measure |
Furosemide + Enhanced Recovery After Surgery (ERAS)
n=62 Participants
Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
|
Enhanced Recovery After Surgery (ERAS)
n=61 Participants
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.
|
|---|---|---|
|
Number of Participants With Hypokalemia
|
2 Participants
|
3 Participants
|
Adverse Events
Furosemide + Enhanced Recovery After Surgery (ERAS)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Enhanced Recovery After Surgery (ERAS)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Furosemide + Enhanced Recovery After Surgery (ERAS)
n=62 participants at risk
Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm.
|
Enhanced Recovery After Surgery (ERAS)
n=61 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Decreased Potassium
|
3.2%
2/62 • Number of events 2 • 1 month
|
4.9%
3/61 • Number of events 3 • 1 month
|
|
Renal and urinary disorders
Increased Serum Creatinine
|
3.2%
2/62 • Number of events 2 • 1 month
|
0.00%
0/61 • 1 month
|
|
Cardiac disorders
Decreased blood pressure
|
4.8%
3/62 • Number of events 3 • 1 month
|
0.00%
0/61 • 1 month
|
|
Cardiac disorders
Atrial Fibrillation
|
1.6%
1/62 • Number of events 1 • 1 month
|
0.00%
0/61 • 1 month
|
|
Renal and urinary disorders
Urine leak
|
0.00%
0/62 • 1 month
|
1.6%
1/61 • Number of events 1 • 1 month
|
|
Cardiac disorders
Increased heart rate
|
1.6%
1/62 • Number of events 1 • 1 month
|
0.00%
0/61 • 1 month
|
|
General disorders
Increased temperature
|
1.6%
1/62 • Number of events 1 • 1 month
|
0.00%
0/61 • 1 month
|
|
Blood and lymphatic system disorders
Hematoma/Anemia
|
1.6%
1/62 • Number of events 1 • 1 month
|
0.00%
0/61 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place