Glycemic ControlNCT01916733
A Quality Initiative to Improve Glycemic Control in Diabetic and Non-Diabetic Insulin Study
An observational study of Glycemic Control and Surgical Site Infections, run by University of Vermont Medical Center at 1 site in United States.
Trial summary
The aim of this study is to examine the effect of moderate glucose (blood sugar) control in diabetic and non-diabetic patients undergoing leg bypass surgery (LEB) or open abdominal aortic aneurysm (AAA) repair. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Glycemic Control, Surgical Site Infections, Cardiac Complications
- What is being tested?
- standard insulin protocol post-op (continuous IV insulin)
- Type of treatment
- Injection or infusion
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: LEB and open AAA patients
Who may be able to join
- Consecutive patients, all patients on the vascular service undergoing elective open AAA repair or infrainguinal LEB for claudication or critical limb ischemia will be approached and given the choice to participate in or to decline the study. Diabetic and non-diabetic.
Who cannot join
- Patients with purely acute limb ischemia will be excluded. Emergency operations including ruptured AAA repairs will be excluded. Also patients on a preoperative insulin infusion will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fletcher Allen Health Care
Burlington, Vermont, 05401
About this study
Official title: A Quality Initiative to Improve Glycemic Control in Diabetic and Non-Diabetic Patients After Vascular Surgery
The aim of this study is to examine the effect of moderate glucose (blood sugar) control in diabetic and non-diabetic patients undergoing leg bypass surgery (LEB) or open abdominal aortic aneurysm (AAA) repair. We hypothesize that use of Fletcher Allen Health Care's current insulin infusion strategy will result in improved blood sugar control which will translate into decreased postoperative morbidity (fewer complications) and better long term outcomes when compared to patient outcomes at other institutions which utilize other blood sugar management strategies.
Read the detailed description
We plan a concurrent, matched cohort study of moderate postoperative glucose control in patients undergoing leg bypass or open AAA repair. Consecutive patients undergoing elective open AAA repair or leg bypass will be enrolled over a two year period. A population of de-identified patients from other institutions in the region matched for medical problems who did not receive an insulin infusion will be used as a control group.
Continuous intravenous insulin protocol The insulin infusion strategy is local standard of care for control of postoperative hyperglycemia after leg bypass surgery. Blood glucose monitoring is standard after open AAA surgery but the method of glucose control could range from sliding scale insulin to the use of an insulin infusion.
Diabetic and non-diabetic patients will be placed on the existing Fletcher Allen Health Care standardized algorithm of continuous IV insulin immediately after surgery and continued for 72 hours. The insulin infusion will be initiated if/ when the finger stick blood glucose is greater than or equal to 120 mg/dL, with a target titration goal between 80-150 mg/dL. The insulin infusion will be adjusted based on a defined algorithm in use at Fletcher Allen Health Care.
Primary outcome measures:
- Glycemic control as measured by mean daily glucose levels and mean daily glucose excursions. We will look at the patients' finger-stick records and record the time spent at goal glucose levels, 80 to 150 mg/dL.
- Surgical site infection (SSI) in-hospital will be defined according to the Centers for Disease Control definition16 as an infection that occurs within 30 days after the operative procedure and involves only skin and subcutaneous tissue of the infection and includes one of the following:
- purulent drainage from superficial incision
- organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision
- at least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat and the incision is deliberately opened by the surgeon, and is culture positive or not cultured. Culture negative does not meet this criterion.
- Diagnosis of superficial incisional SSI by the surgeon or attending. . 3. Surgical site infection at 30 days.
Secondary outcome measures:
- Moderate to severe hypoglycemic or hyperglycemic events as defined by moderate hypoglycemic event as <66 mg/dl and severe hypoglycemic event as <50 mg/dl and moderate hyperglycemic event as >250 mg/dl and severe hyperglycemic event as >500 mg/dl.
- Composite cardiac complications: myocardial infarction, congestive heart failure and clinically significant arrhythmias within 30 days of surgery,
- Hospital length of stay, re-admission and total costs of the hospitalization. Cost data will be obtained through Fletcher Allen Health Care administrative data. At the patient's 4 week follow up they will be asked if since their discharge have they had any health related visits; if so what type and for anything possibly related to the surgical procedure obtain the participants permission (in writing) to gather that data from the other provider.
- Being tested
- standard insulin protocol post-op (continuous IV insulin)
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard insulin protocol post-op (continuous IV insulin)Drug
concurrent, matched cohort study of moderate postoperative glucose control in patients undergoing LEB or open AAA repair.Propensity score matching is a statistical method used to reduce the confounding effects of covariates in an observational (non-randomized) study. In practice we will select a number of variables that impact wound infection; age, gender, diabetic and non-diabetic populations, renal insufficiency (defined at creatinine ≥1.8) and indication for surgery (claudication or critical limb ischemia with rest pain or tissue loss or open AAA repair); and chose a group of patients in the Vascular Study Group matched for these variables who have not been treated with an insulin infusion). Consecutive patients undergoing elective open AAA repair or infrainguinal LEB for claudication and critical limb ischemia will be invited to enroll in the study.
| Study group | Role | What they receive |
|---|---|---|
| Lower Extremity Bypass & open AAA | Lower Extremity Bypass (LEB) and open AAA patients will be placed on standard Fletcher Allen Health Care insulin protocol post op Receives: Drug: standard insulin protocol post-op (continuous IV insulin) | |
| control | patients from the Vascular Study Group of New England centers without a defined program for glucose control after lower extremity bypass and open AAA repair will be used |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic control
- Glycemic control as measured by mean daily glucose levels and mean daily glucose excursions. We will look at the patients' finger-stick records and record the time spent at goal glucose levels, 80 to 150 mg/dL.
Measured: during intial hospital stay which is an average of 3 to 7 days
surgical site infection
Surgical site infection (SSI) in-hospital will be defined according to the Centers for Disease Control definition16 as an infection that occurs within 30 days after the operative procedure and involves only skin and subcutaneous tissue of the infection and includes one of the following:
- purulent drainage from superficial incision
- organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision
- at least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat and the incision is deliberately opened by the surgeon, and is culture positive or not cultured. Culture negative does not meet this criterion.
- Diagnosis of superficial incisional SSI by the surgeon or attending.
Measured: 30 days
Secondary outcomes (5)
hypo and hyper glycemic events
. Moderate to severe hypoglycemic or hyperglycemic events as defined by moderate hypoglycemic event as <66 mg/dl and severe hypoglycemic event as <50 mg/dl and moderate hyperglycemic event as >250 mg/dl and severe hyperglycemic event as >500 mg/dl.
Measured: during initial hospital stay avg 3 to 7 days
cardiac complications
Composite cardiac complications: myocardial infarction, congestive heart failure and clinically significant arrhythmias within 30 days of surgery
Measured: 30 days
length of stay
Hospital length of stay
Measured: initial hospitalization avg 3 to 7 days
re-admission
At the patient's 4 week follow-up they will be asked if since their discharge have they had any health related visits; if so what type and for anything possibly related to surgical procedure; will obtain participant's permission (in writing) to gather data from other provider.
Measured: at 4 week follow-up
Costs
Cost data will be obtained through Fletcher Allen administrative data.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic ControlStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Bertges, MD, University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916733
- Sponsor's protocol ID
- M12-172
- Other IDs
- UVM Medical Group
- Status last verified
- Oct 2016
- First submitted
- 30 Jul 2013
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quality Initiative to Improve Glycemic Control in Diabetic and Non-Diabetic Patients After Vascular Surgery
- ClinicalTrials.gov ID
- NCT01916733
- Acronym / sponsor ID
- M12-172
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to examine the effect of moderate glucose (blood sugar) control in diabetic and non-diabetic patients undergoing leg bypass surgery (LEB) or open abdominal aortic aneurysm (AAA) repair. We hypothesize that use of Fletcher Allen Health Care's current insulin infusion strategy will result in improved blood sugar control which will translate into decreased postoperative morbidity (fewer complications) and better long term outcomes when compared to patient outcomes at other institutions which utilize other blood sugar management strategies.
Detailed description
We plan a concurrent, matched cohort study of moderate postoperative glucose control in patients undergoing leg bypass or open AAA repair. Consecutive patients undergoing elective open AAA repair or leg bypass will be enrolled over a two year period. A population of de-identified patients from other institutions in the region matched for medical problems who did not receive an insulin infusion will be used as a control group.
Continuous intravenous insulin protocol The insulin infusion strategy is local standard of care for control of postoperative hyperglycemia after leg bypass surgery. Blood glucose monitoring is standard after open AAA surgery but the method of glucose control could range from sliding scale insulin to the use of an insulin infusion.
Diabetic and non-diabetic patients will be placed on the existing Fletcher Allen Health Care standardized algorithm of continuous IV insulin immediately after surgery and continued for 72 hours. The insulin infusion will be initiated if/ when the finger stick blood glucose is greater than or equal to 120 mg/dL, with a target titration goal between 80-150 mg/dL. The insulin infusion will be adjusted based on a defined algorithm in use at Fletcher Allen Health Care.
Primary outcome measures:
- Glycemic control as measured by mean daily glucose levels and mean daily glucose excursions. We will look at the patients' finger-stick records and record the time spent at goal glucose levels, 80 to 150 mg/dL.
- Surgical site infection (SSI) in-hospital will be defined according to the Centers for Disease Control definition16 as an infection that occurs within 30 days after the operative procedure and involves only skin and subcutaneous tissue of the infection and includes one of the following:
- purulent drainage from superficial incision
- organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision
- at least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat and the incision is deliberately opened by the surgeon, and is culture positive or not cultured. Culture negative does not meet this criterion.
- Diagnosis of superficial incisional SSI by the surgeon or attending. . 3. Surgical site infection at 30 days.
Secondary outcome measures:
- Moderate to severe hypoglycemic or hyperglycemic events as defined by moderate hypoglycemic event as <66 mg/dl and severe hypoglycemic event as <50 mg/dl and moderate hyperglycemic event as >250 mg/dl and severe hyperglycemic event as >500 mg/dl.
- Composite cardiac complications: myocardial infarction, congestive heart failure and clinically significant arrhythmias within 30 days of surgery,
- Hospital length of stay, re-admission and total costs of the hospitalization. Cost data will be obtained through Fletcher Allen Health Care administrative data. At the patient's 4 week follow up they will be asked if since their discharge have they had any health related visits; if so what type and for anything possibly related to the surgical procedure obtain the participants permission (in writing) to gather that data from the other provider.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower Extremity Bypass & open AAA | – | Drug: standard insulin protocol post-op (continuous IV insulin)Lower Extremity Bypass (LEB) and open AAA patients will be placed on standard Fletcher Allen Health Care insulin protocol post op |
| control | – | –patients from the Vascular Study Group of New England centers without a defined program for glucose control after lower extremity bypass and open AAA repair will be used |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- LEB and open AAA patients
Key inclusion criteria (1 listed)
- Consecutive patients, all patients on the vascular service undergoing elective open AAA repair or infrainguinal LEB for claudication or critical limb ischemia will be approached and given the choice to participate in or to decline the study. Diabetic and non-diabetic.
Key exclusion criteria (1 listed)
- Patients with purely acute limb ischemia will be excluded. Emergency operations including ruptured AAA repairs will be excluded. Also patients on a preoperative insulin infusion will be excluded.
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 |
|---|---|---|
| standard insulin protocol post-op (continuous IV insulin)concurrent, matched cohort study of moderate postoperative glucose control in patients undergoing LEB or open AAA repair.Propensity score matching is a statistical method used to reduce the confounding effects of covariates in an observational (non-randomized) study. In practice we will select a number of variables that impact wound infection; age, gender, diabetic and non-diabetic populations, renal insufficiency (defined at creatinine ≥1.8) and indication for surgery (claudication or critical limb ischemia with rest pain or tissue loss or open AAA repair); and chose a group of patients in the Vascular Study Group matched for these variables who have not been treated with an insulin infusion). Consecutive patients undergoing elective open AAA repair or infrainguinal LEB for claudication and critical limb ischemia will be invited to enroll in the study. | Drug | Lower Extremity Bypass & open AAA |
Primary outcome
glycemic control
Time frame: during intial hospital stay which is an average of 3 to 7 days
1. Glycemic control as measured by mean daily glucose levels and mean daily glucose excursions. We will look at the patients' finger-stick records and record the time spent at goal glucose levels, 80 to 150 mg/dL.
surgical site infection
Time frame: 30 days
Surgical site infection (SSI) in-hospital will be defined according to the Centers for Disease Control definition16 as an infection that occurs within 30 days after the operative procedure and involves only skin and subcutaneous tissue of the infection and includes one of the following: * purulent drainage from superficial incision * organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision * at least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat and the incision is deliberately opened by the surgeon, and is culture positive or not cultured. Culture negative does not meet this criterion. * Diagnosis of superficial incisional SSI by the surgeon or attending.
5 secondary outcomes
hypo and hyper glycemic events
Time frame: during initial hospital stay avg 3 to 7 days
cardiac complications
Time frame: 30 days
length of stay
Time frame: initial hospitalization avg 3 to 7 days
re-admission
Time frame: at 4 week follow-up
Costs
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glycemic Control and Surgical Site Infections, run by University of Vermont Medical Center 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 1 inclusion and 1 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 25 Oct 2016. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
glycemic control (time frame: during intial hospital stay which is an average of 3 to 7 days). The study lists 2 primary outcomes in all. 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 25 Oct 2016.