Colorectal DisordersPhase 4NCT02351934
Early Diuresis Following Colorectal Surgery
A Phase 4 study testing Furosemide, Celecoxib and Gabapentin in people with Colorectal Disorders, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Disorders
- What is being tested?
- Furosemide, Celecoxib and Gabapentin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Apr 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All elective colorectal surgeries (CRS) utilizing the enhanced recovery pathway (ERP)
- The surgery involves resection
Who cannot join
- Surgeries involving intraoperative radiation
- Ileostomy closures, when performed as the only surgical intervention
- Surgeries involving multiple disciplines (e.g., colorectal plus general surgery, colorectal plus gynecology surgery) except for colorectal surgeries plus ureteral stent placements.
- Chronic loop diuretic therapy (i.e., bumetanide, torsemide, furosemide, ethacrynic acid) including as needed administration of such therapy
- Patients receiving dialysis
- Creatinine clearance, calculated by the Cockcroft-Gault equation, less than 30 mL/min.
Show all 22Show fewer
- Inpatient prior to surgery
- Allergy to furosemide
- Allergy to sulfa drugs if the allergy involves anaphylactic reaction
- Lack of serum creatinine concentration within 3 months preceding the surgery AND diagnosis of chronic kidney disease
- Exclusion Criteria for Intervention (applies to both the intervention and control arm):
- Patient's weight on postoperative day (POD) #1 and POD #2 is less than preoperative weight.
- Blood pressure criteria: systolic blood pressure criteria less than 90 mmHg or greater than 30 mmHg below baseline on POD #1 and/or POD #2 immediately prior to administration of study drug.
- Complications within 48 hours of surgery
- Abscess (infected fluid collection, treated with CT drainage)
- Leak (defined by CT drainage or reoperation)
- Wound infection (treated with either antibiotics and/or open packing)
- Bowel obstruction (treated with reoperation)
- Reoperation
- Hemorrhage
- Weight change since admission on POD #1: > 5 kg
- Acute kidney injury on POD #1 and POD#2 defined as serum creatinine (SCr) increase ≥ 0.3 mg/dL or increase to ≥ 150% to 200% (1.5- to 2-fold) from baseline
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Prospective, Randomized Study Evaluating the Efficacy and Safety of Early Diuresis Following Colorectal Surgery
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.
Read the 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.
- Conditions
- Colorectal Disorders
- Being tested
- Furosemide, Celecoxib, Gabapentin
- Keywords
- colorectal surgery, volume status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
Also called Lasix
CelecoxibDrug
Also called Celebrex
Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation.
GabapentinDrug
Also called Neurontin
Gabapentin is a oral drug used to treat seizures, postherpetic neuralgia, and restless legs syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Furosemide + Enhanced Recovery after Surgery (ERAS) | Experimental | Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm. Receives: Drug: Furosemide; Drug: Celecoxib; Drug: Gabapentin |
| Enhanced Recovery after Surgery (ERAS) | Active comparator | 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. Receives: Drug: Celecoxib; Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay
Participants will be followed for the duration of hospital stay, an expected average of 2-7 days.
Measured: Up to 7 days
Secondary outcomes (5)
Number of Participants Readmitted to Mayo Clinic Within 30-days
Measured: Within 30 days of release from hospital
Number of Participants Requiring Nasogastric Tube Placement
Measured: Up to 7 days
Time to Stool Output
Measured: Up to 4 days
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.
Measured: Up to 7 days
Number of Participants With Hypokalemia
Hypokalemia is generally defined as a serum potassium level of less than 3.5 mmol/L.
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal DisordersStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilya M. Danelich, Pharm.D., R.Ph., Mayo Clinic
- Investigators
- Ilya Danelich, PharmD, RPh, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351934
- Sponsor's protocol ID
- 14-008292
- Other IDs
- UL1TR000135
- Status last verified
- Apr 2018
- First submitted
- 23 Jan 2015
- Last updated
- 7 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Study Evaluating the Efficacy and Safety of Early Diuresis Following Colorectal Surgery
- ClinicalTrials.gov ID
- NCT02351934
- Acronym / sponsor ID
- 14-008292
- Conditions
- Colorectal Disorders
- Keywords
- colorectal surgery, volume status
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 30 Jan 2015 (estimated)
- Results
- Posted 27 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Furosemide + Enhanced Recovery after Surgery (ERAS) | Experimental | Drug: Furosemide, Drug: Celecoxib, Drug: GabapentinFurosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm. |
| Enhanced Recovery after Surgery (ERAS) | Active comparator | Drug: Celecoxib, Drug: GabapentinERAS 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All elective colorectal surgeries (CRS) utilizing the enhanced recovery pathway (ERP)
- The surgery involves resection
Key exclusion criteria (22 listed)
- Surgeries involving intraoperative radiation
- Ileostomy closures, when performed as the only surgical intervention
- Surgeries involving multiple disciplines (e.g., colorectal plus general surgery, colorectal plus gynecology surgery) except for colorectal surgeries plus ureteral stent placements.
- Chronic loop diuretic therapy (i.e., bumetanide, torsemide, furosemide, ethacrynic acid) including as needed administration of such therapy
- Patients receiving dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FurosemideAlso: Lasix | Drug | Furosemide + Enhanced Recovery after Surgery (ERAS) |
| CelecoxibAlso: CelebrexCelecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation. | Drug | Enhanced Recovery after Surgery (ERAS), Furosemide + Enhanced Recovery after Surgery (ERAS) |
| GabapentinAlso: NeurontinGabapentin is a oral drug used to treat seizures, postherpetic neuralgia, and restless legs syndrome. | Drug | Enhanced Recovery after Surgery (ERAS), Furosemide + Enhanced Recovery after Surgery (ERAS) |
Primary outcome
Length of Hospital Stay
Time frame: Up to 7 days
Participants will be followed for the duration of hospital stay, an expected average of 2-7 days.
5 secondary outcomes
Number of Participants Readmitted to Mayo Clinic Within 30-days
Time frame: Within 30 days of release from hospital
Number of Participants Requiring Nasogastric Tube Placement
Time frame: Up to 7 days
Time to Stool Output
Time frame: Up to 4 days
Number of Participants With Acute Kidney Injury
Time frame: Up to 7 days
Number of Participants With Hypokalemia
Time frame: Up to 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Colorectal Disorders
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilya Danelich, PharmD, RPh principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Furosemide, Celecoxib and Gabapentin in people with Colorectal Disorders, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospital Stay (time frame: Up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.