Peripheral Vascular DiseaseNCT00328094
Glycemic Control to Prevent Cardiac Morbidity in Vascular Surgery
A study testing continuous intravenous insulin infusion in people with Peripheral Vascular Disease and Abdominal Aortic Aneurysm, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Aggressive intraoperative and postoperative management of blood glucose may substantially decrease perioperative cardiovascular and infectious complications in diabetic and non-diabetic patients undergoing vascular surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease, Abdominal Aortic Aneurysm
- What is being tested?
- continuous intravenous insulin infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to May 2009
- Phase
- Interventional
- 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
- Abdominal aortic surgery
- Supra and infrainguinal peripheral vascular bypass surgery
- Below knee amputations
- Above knee amputations
- Diabetics and nondiabetics
- American Society of Anesthesiologists (ASA) I-III
Who cannot join
- Brittle diabetics
- ASA 1V,V
- Second surgery in same admission
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Impact of Tight Control of Perioperative Blood Glucose in Patients Undergoing Vascular Surgery on Their Perioperative Cardiovascular and Overall Morbidity and Mortality
Aggressive intraoperative and postoperative management of blood glucose may substantially decrease perioperative cardiovascular and infectious complications in diabetic and non-diabetic patients undergoing vascular surgery.
The purpose of this study is to compare the tight versus traditional blood glucose control in diabetics and non-diabetics undergoing vascular surgery in regard to their postoperative fatal and nonfatal cardiac outcomes, and the secondary effects such as rate of infections, overall morbidity and 30-day mortality.
Read the detailed description
This is a randomized, prospective controlled trial in both diabetic and non diabetic patients undergoing vascular surgery such as abdominal aortic, infra inguinal vascular bypass procedures and amputations, comparing tight versus standard blood glucose control regimens in the operating room, post anesthesia care unit and in the postoperative vascular intensive care unit up to 48 hours and its impact on the cardiovascular, infectious and other morbidity and mortality during the hospital admission and up to 30 days from surgery.
After obtaining informed consent, the study subjects will be randomized to tight versus standard blood glucose control regimens. These regimens will be started in the operating room and continued for the first 48 hours or until their discharge, whichever is earlier. All the patients will be inpatients. Day surgery patients will be excluded.
The anesthesiologist providing patient care will be given either the tight glucose control protocol or the standard sliding scale insulin protocol. In the tight control regimen, target blood glucose is 100-150 mg/dl. If 3 consecutive blood glucose (BG) level >150 mg/dL or 1 BG level >200 mg/dL, then the insulin infusion will be initiated in the tight control group. The insulin infusion rate adjustments will be made based on the blood sugar results. In post anesthetic care unit (PACU) and vascular intensive care unit (VICU), these protocols will be nurse driven. The adjustments will be made based on the current blood sugar levels as well as the insulin infusion rates. They are adjusted in such a way to account for the rate of change of blood sugars and the presence of steroid therapy in the patients. The frequency of blood glucose testing in this group will be every 1-hour until stable (when frequent changes in insulin dosage are no longer necessary, and glucose is in the range of 100 to 150 for 3 consecutive blood sugar checks); then test every 2 hours for 3 consecutive target values and then every 4 hours thereafter. If there is a change in the infusion rates, then blood sugar checks will be done every hour and the cycle followed thereafter.
In the standard sliding scale insulin group, blood sugars will be treated with insulin boluses if the blood sugars go more than 150 mg/dL and blood glucose will be monitored every 4 hours.
These regimens will be initiated after 2 weeks of in-service training for anesthesiologists, post anesthetic care unit (PACU) and vascular intensive care unit (VICU) nurses. The study investigators will provide this training. Insulin infusion in the tight control regimen will be started through pump piggyback to maintenance intravenous infusion as follows. Insulin infusion bags will be made by the pharmacy (100 units in a 100 ml bag). The anesthesiologists in the operating room and PACU, and VICU nurses will perform blood glucose monitoring, bolus insulin administration, and infusion initiation and rate adjustments as specified by the protocol. Blood glucose levels will be tested by finger stick method or arterial line drop sample.
- Being tested
- continuous intravenous insulin infusion
- Keywords
- Tight, Glycemic, control, outcomes, peripheral vascular disease, infection, cardiovascular, morbidity, mortality
- Medical subject headings
- Peripheral Vascular Diseases, Aortic Aneurysm, Abdominal, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous intravenous insulin infusionDrug
Also called CII-continuous insulin infusion, II-Intermittent insulin boluses
Tight glucose control versus standard of care
| Study group | Role | What they receive |
|---|---|---|
| CII, Continuous Insulin Infusion | Experimental | Continuous intravenous insulin infusion to control glucose to <150 mg/dL in patients undergoing open peripheral vascular bypass surgery Receives: Drug: continuous intravenous insulin infusion |
| IIB, Intermittent insulin boluses | Active comparator | Intermittent intravenous insulin insulin boluses to a blood glucose target of <150mg/dL in patients undergoing peripheral vascular bypass surgery Receives: Drug: continuous intravenous insulin infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite (Myocardial Infarction and CHF)
Measured: hospital length of stay
Secondary outcomes (1)
Incidence of Wound Infections
Measured: postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startMar 2006
- Primary completionApr 2008
- Study completionMay 2009
Why it stopped: The recruitment rate slowed considerably
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balachundhar Subramaniam, Beth Israel Deaconess Medical Center
- Investigators
- Balachundhar Subramaniam, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328094
- Sponsor's protocol ID
- 2005P-000299
- Status last verified
- Apr 2013
- First submitted
- 18 May 2006
- Last updated
- 17 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Furnary AP, Zerr KJ, Grunkemeier GL, Starr A. Continuous intravenous insulin infusion reduces the incidence of deep sternal wound infection in diabetic patients after cardiac surgical procedures. Ann Thorac Surg. 1999 Feb;67(2):352-60; discussion 360-2. doi: 10.1016/s0003-4975(99)00014-4.
PubMed 10197653van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.
PubMed 11794168Zimmerman CR, Mlynarek ME, Jordan JA, Rajda CA, Horst HM. An insulin infusion protocol in critically ill cardiothoracic surgery patients. Ann Pharmacother. 2004 Jul-Aug;38(7-8):1123-9. doi: 10.1345/aph.1E018. Epub 2004 May 18.
PubMed 15150382Kersten JR, Warltier DC, Pagel PS. Aggressive control of intraoperative blood glucose concentration: a shifting paradigm? Anesthesiology. 2005 Oct;103(4):677-8. doi: 10.1097/00000542-200510000-00002. No abstract available.
PubMed 16192757
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Tight Control of Perioperative Blood Glucose in Patients Undergoing Vascular Surgery on Their Perioperative Cardiovascular and Overall Morbidity and Mortality
- ClinicalTrials.gov ID
- NCT00328094
- Acronym / sponsor ID
- 2005P-000299
- Keywords
- Tight, Glycemic, control, outcomes, peripheral vascular disease, infection, cardiovascular, morbidity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The recruitment rate slowed considerably
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 19 May 2006 (estimated)
- Results
- Posted 9 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aggressive intraoperative and postoperative management of blood glucose may substantially decrease perioperative cardiovascular and infectious complications in diabetic and non-diabetic patients undergoing vascular surgery.
The purpose of this study is to compare the tight versus traditional blood glucose control in diabetics and non-diabetics undergoing vascular surgery in regard to their postoperative fatal and nonfatal cardiac outcomes, and the secondary effects such as rate of infections, overall morbidity and 30-day mortality.
Detailed description
This is a randomized, prospective controlled trial in both diabetic and non diabetic patients undergoing vascular surgery such as abdominal aortic, infra inguinal vascular bypass procedures and amputations, comparing tight versus standard blood glucose control regimens in the operating room, post anesthesia care unit and in the postoperative vascular intensive care unit up to 48 hours and its impact on the cardiovascular, infectious and other morbidity and mortality during the hospital admission and up to 30 days from surgery.
After obtaining informed consent, the study subjects will be randomized to tight versus standard blood glucose control regimens. These regimens will be started in the operating room and continued for the first 48 hours or until their discharge, whichever is earlier. All the patients will be inpatients. Day surgery patients will be excluded.
The anesthesiologist providing patient care will be given either the tight glucose control protocol or the standard sliding scale insulin protocol. In the tight control regimen, target blood glucose is 100-150 mg/dl. If 3 consecutive blood glucose (BG) level >150 mg/dL or 1 BG level >200 mg/dL, then the insulin infusion will be initiated in the tight control group. The insulin infusion rate adjustments will be made based on the blood sugar results. In post anesthetic care unit (PACU) and vascular intensive care unit (VICU), these protocols will be nurse driven. The adjustments will be made based on the current blood sugar levels as well as the insulin infusion rates. They are adjusted in such a way to account for the rate of change of blood sugars and the presence of steroid therapy in the patients. The frequency of blood glucose testing in this group will be every 1-hour until stable (when frequent changes in insulin dosage are no longer necessary, and glucose is in the range of 100 to 150 for 3 consecutive blood sugar checks); then test every 2 hours for 3 consecutive target values and then every 4 hours thereafter. If there is a change in the infusion rates, then blood sugar checks will be done every hour and the cycle followed thereafter.
In the standard sliding scale insulin group, blood sugars will be treated with insulin boluses if the blood sugars go more than 150 mg/dL and blood glucose will be monitored every 4 hours.
These regimens will be initiated after 2 weeks of in-service training for anesthesiologists, post anesthetic care unit (PACU) and vascular intensive care unit (VICU) nurses. The study investigators will provide this training. Insulin infusion in the tight control regimen will be started through pump piggyback to maintenance intravenous infusion as follows. Insulin infusion bags will be made by the pharmacy (100 units in a 100 ml bag). The anesthesiologists in the operating room and PACU, and VICU nurses will perform blood glucose monitoring, bolus insulin administration, and infusion initiation and rate adjustments as specified by the protocol. Blood glucose levels will be tested by finger stick method or arterial line drop sample.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CII, Continuous Insulin Infusion | Experimental | Drug: continuous intravenous insulin infusionContinuous intravenous insulin infusion to control glucose to <150 mg/dL in patients undergoing open peripheral vascular bypass surgery |
| IIB, Intermittent insulin boluses | Active comparator | Drug: continuous intravenous insulin infusionIntermittent intravenous insulin insulin boluses to a blood glucose target of <150mg/dL in patients undergoing peripheral vascular bypass surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Abdominal aortic surgery
- Supra and infrainguinal peripheral vascular bypass surgery
- Below knee amputations
- Above knee amputations
- Diabetics and nondiabetics
Key exclusion criteria (3 listed)
- Brittle diabetics
- ASA 1V,V
- Second surgery in same admission
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 |
|---|---|---|
| continuous intravenous insulin infusionAlso: CII-continuous insulin infusion, II-Intermittent insulin bolusesTight glucose control versus standard of care | Drug | CII, Continuous Insulin Infusion, IIB, Intermittent insulin boluses |
Primary outcome
Composite (Myocardial Infarction and CHF)
Time frame: hospital length of stay
1 secondary outcome
Incidence of Wound Infections
Time frame: postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10197653Furnary AP, Zerr KJ, Grunkemeier GL, Starr A. Continuous intravenous insulin infusion reduces the incidence of deep sternal wound infection in diabetic patients after cardiac surgical procedures. Ann Thorac Surg. 1999 Feb;67(2):352-60; discussion 360-2. doi: 10.1016/s0003-4975(99)00014-4.
- Background: PubMed 11794168van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.
- Background: PubMed 15150382Zimmerman CR, Mlynarek ME, Jordan JA, Rajda CA, Horst HM. An insulin infusion protocol in critically ill cardiothoracic surgery patients. Ann Pharmacother. 2004 Jul-Aug;38(7-8):1123-9. doi: 10.1345/aph.1E018. Epub 2004 May 18.
- Background: PubMed 16192757Kersten JR, Warltier DC, Pagel PS. Aggressive control of intraoperative blood glucose concentration: a shifting paradigm? Anesthesiology. 2005 Oct;103(4):677-8. doi: 10.1097/00000542-200510000-00002. No abstract available.
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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.
Balachundhar Subramaniam principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous intravenous insulin infusion in people with Peripheral Vascular Disease and Abdominal Aortic Aneurysm, run by Beth Israel Deaconess 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 6 inclusion and 3 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: stopped early, as of the sponsor's last update on 17 Apr 2013. 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?
Yes. Results are posted in the registry (first posted 9 Apr 2013). 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?
Composite (Myocardial Infarction and CHF) (time frame: hospital length of stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00328094, which also lists 4 linked publications.
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 17 Apr 2013.