Blood GlucoseNCT04451655
Glycemic Stability During the Intraoperative Period Among Patients With DM Undergoing CABG Surgery
A study testing Continuous insulin infusion in people with Blood Glucose, run by Audai A. Hayajneh at 1 site in Jordan.
Trial summary
Objectives: Intraoperative glycemic stability and control among patients with diabetes mellitus (DM) undergoing coronary artery bypass grafting (CABG) surgery remains a significant concern. Read more about this study
- Who is it for?
- Ages 43 to 74 years
- Conditions the study is for
- Blood Glucose
- What is being tested?
- Continuous insulin infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteJordan
- Study dates
- 1 Sep 2018to 30 Nov 2018
- Phase
- Interventional
- 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 43 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult Jordanian patients
- diagnosed with DM
- who had been scheduled to CABG surgery
Who cannot join
- Participants who were immunosuppressed were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Objectives: Intraoperative glycemic stability and control among patients with diabetes mellitus (DM) undergoing coronary artery bypass grafting (CABG) surgery remains a significant concern. In this study, the intraoperative glycemic stability among diabetic patients undergoing CABG surgery was compared between patients who received an intravenous continuous insulin infusion (CII) for tight glycemic control with those who received an CII for conventional glycemic control, during the intraoperative period.
Research Design and Methods: This study implemented a quasi-experimental design with a convenience sample of 144 patients with DM undergoing CABG surgery at a major hospital in Amman, Jordan.
Read the detailed description
Objectives: Intraoperative glycemic stability and control among patients with diabetes mellitus (DM) undergoing coronary artery bypass grafting (CABG) surgery remains a significant concern. In this study, the intraoperative glycemic stability among diabetic patients undergoing CABG surgery was compared between patients who received an intravenous continuous insulin infusion (CII) for tight glycemic control with those who received an CII for conventional glycemic control, during the intraoperative period.
Research Design and Methods: This study implemented a quasi-experimental design with a convenience sample of 144 patients with DM undergoing CABG surgery at a major hospital in Amman, Jordan. Participants were randomly assigned to either a tight glycemic control group (n=72) or a conventional glycemic control group (n=72). Patients who received the tight glycemic control protocol had significantly more consistent and lower mean intraoperative BG levels than those who received the conventional glycemic control protocol. The tight glycemic control protocol resulted in significantly lower BG levels and fewer variations across each time-point and more consistent and stable BG levels than the conventional glycemic control protocol.
- Conditions
- Blood Glucose
- Being tested
- Continuous insulin infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous insulin infusionDrug
This study aims to explore the hypothesis that diabetic patients undergoing coronary artery bypass graft (CABG) surgery receiving intravenous continuous insulin infusion (CII) for tight glycemic control (110-149 mg/dl) protocol during the intraoperative period would have improved intraoperative glycemic stability, efficacy and consistency compared to patients receiving conventional glycemic control (150-180 mg/dl) protocol during the intraoperative period
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Not described Receives: Drug: Continuous insulin infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative glycemic instability
Intraoperative glycemic instability is defined as three consecutive readings of intraoperative blood glucose (BG) levels outside the pre-set targeted ranges of the protocols, whether higher or lower than the limits
Measured: every half hour for eight hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start1 Sep 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Blood GlucoseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Audai A. Hayajneh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Audai A. Hayajneh, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451655
- Sponsor's protocol ID
- JUST20180441
- Status last verified
- Jun 2020
- First submitted
- 25 Jun 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boreland L, Scott-Hudson M, Hetherington K, Frussinetty A, Slyer JT. The effectiveness of tight glycemic control on decreasing surgical site infections and readmission rates in adult patients with diabetes undergoing cardiac surgery: A systematic review. Heart Lung. 2015 Sep-Oct;44(5):430-40. doi: 10.1016/j.hrtlng.2015.06.004. Epub 2015 Jun 29.
PubMed 26138777Ogawa S, Okawa Y, Sawada K, Goto Y, Yamamoto M, Koyama Y, Baba H, Suzuki T. Continuous postoperative insulin infusion reduces deep sternal wound infection in patients with diabetes undergoing coronary artery bypass grafting using bilateral internal mammary artery grafts: a propensity-matched analysis. Eur J Cardiothorac Surg. 2016 Feb;49(2):420-6. doi: 10.1093/ejcts/ezv106. Epub 2015 Mar 29.
PubMed 25825261de Vries FE, Gans SL, Solomkin JS, Allegranzi B, Egger M, Dellinger EP, Boermeester MA. Meta-analysis of lower perioperative blood glucose target levels for reduction of surgical-site infection. Br J Surg. 2017 Jan;104(2):e95-e105. doi: 10.1002/bjs.10424. Epub 2016 Nov 30.
PubMed 27901264Hua J, Chen G, Li H, Fu S, Zhang LM, Scott M, Li Q. Intensive intraoperative insulin therapy versus conventional insulin therapy during cardiac surgery: a meta-analysis. J Cardiothorac Vasc Anesth. 2012 Oct;26(5):829-34. doi: 10.1053/j.jvca.2011.12.016. Epub 2012 Feb 14.
PubMed 22336691Wahby, Ehab A, Elnasr M. M. Abo, Michael I. Eissa, and Sahbaa M. Mahmoud.
Gandhi GY, Nuttall GA, Abel MD, Mullany CJ, Schaff HV, O'Brien PC, Johnson MG, Williams AR, Cutshall SM, Mundy LM, Rizza RA, McMahon MM. Intensive intraoperative insulin therapy versus conventional glucose management during cardiac surgery: a randomized trial. Ann Intern Med. 2007 Feb 20;146(4):233-43. doi: 10.7326/0003-4819-146-4-200702200-00002.
PubMed 17310047Greco G, Shi W, Michler RE, Meltzer DO, Ailawadi G, Hohmann SF, Thourani VH, Argenziano M, Alexander JH, Sankovic K, Gupta L, Blackstone EH, Acker MA, Russo MJ, Lee A, Burks SG, Gelijns AC, Bagiella E, Moskowitz AJ, Gardner TJ. Costs associated with health care-associated infections in cardiac surgery. J Am Coll Cardiol. 2015 Jan 6;65(1):15-23. doi: 10.1016/j.jacc.2014.09.079.
PubMed 25572505Lazar HL, Chipkin SR, Fitzgerald CA, Bao Y, Cabral H, Apstein CS. Tight glycemic control in diabetic coronary artery bypass graft patients improves perioperative outcomes and decreases recurrent ischemic events. Circulation. 2004 Mar 30;109(12):1497-502. doi: 10.1161/01.CIR.0000121747.71054.79. Epub 2004 Mar 8.
PubMed 15006999Benneyan JC. Use and interpretation of statistical quality control charts. Int J Qual Health Care. 1998 Feb;10(1):69-73. doi: 10.1093/intqhc/10.1.69. No abstract available.
PubMed 10030790Canadian Diabetes Association Clinical Practice Guidelines Expert Committee; Imran SA, Rabasa-Lhoret R, Ross S. Targets for glycemic control. Can J Diabetes. 2013 Apr;37 Suppl 1:S31-4. doi: 10.1016/j.jcjd.2013.01.016. Epub 2013 Mar 26. No abstract available.
PubMed 24070959Bhamidipati CM, LaPar DJ, Stukenborg GJ, Morrison CC, Kern JA, Kron IL, Ailawadi G. Superiority of moderate control of hyperglycemia to tight control in patients undergoing coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2011 Feb;141(2):543-51. doi: 10.1016/j.jtcvs.2010.10.005. Epub 2010 Dec 15.
PubMed 21163498Finfer, S, DR Chittock, SY Su, D Blair, D Foster, V Dhingra, R Bellomo, D Cook, P Dodek, WR Henderson, PC Hébert, S Heritier, DK Heyland, C McArthur, E McDonald, I Mitchell, JA Myburgh, R Norton, J Potter, BG Robinson, and JJ Ronco.
Furnary AP, Wu Y. Clinical effects of hyperglycemia in the cardiac surgery population: the Portland Diabetic Project. Endocr Pract. 2006 Jul-Aug;12 Suppl 3:22-6. doi: 10.4158/EP.12.S3.22.
PubMed 16905513Umpierrez G, Cardona S, Pasquel F, Jacobs S, Peng L, Unigwe M, Newton CA, Smiley-Byrd D, Vellanki P, Halkos M, Puskas JD, Guyton RA, Thourani VH. Randomized Controlled Trial of Intensive Versus Conservative Glucose Control in Patients Undergoing Coronary Artery Bypass Graft Surgery: GLUCO-CABG Trial. Diabetes Care. 2015 Sep;38(9):1665-72. doi: 10.2337/dc15-0303. Epub 2015 Jul 15.
PubMed 26180108Hweidi IM, Zytoon AM, Hayajneh AA, Al Obeisat SM, Hweidi AI. The effect of intraoperative glycemic control on surgical site infections among diabetic patients undergoing coronary artery bypass graft (CABG) surgery. Heliyon. 2021 Dec 2;7(12):e08529. doi: 10.1016/j.heliyon.2021.e08529. eCollection 2021 Dec.
PubMed 34926859
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Stability During the Intraoperative Period Among Patients With DM Undergoing CABG Surgery
- ClinicalTrials.gov ID
- NCT04451655
- Acronym / sponsor ID
- JUST20180441
- Conditions
- Blood Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Audai A. HayajnehUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 30 Jun 2020 (actual)
- 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.
Objectives: Intraoperative glycemic stability and control among patients with diabetes mellitus (DM) undergoing coronary artery bypass grafting (CABG) surgery remains a significant concern. In this study, the intraoperative glycemic stability among diabetic patients undergoing CABG surgery was compared between patients who received an intravenous continuous insulin infusion (CII) for tight glycemic control with those who received an CII for conventional glycemic control, during the intraoperative period.
Research Design and Methods: This study implemented a quasi-experimental design with a convenience sample of 144 patients with DM undergoing CABG surgery at a major hospital in Amman, Jordan.
Detailed description
Objectives: Intraoperative glycemic stability and control among patients with diabetes mellitus (DM) undergoing coronary artery bypass grafting (CABG) surgery remains a significant concern. In this study, the intraoperative glycemic stability among diabetic patients undergoing CABG surgery was compared between patients who received an intravenous continuous insulin infusion (CII) for tight glycemic control with those who received an CII for conventional glycemic control, during the intraoperative period.
Research Design and Methods: This study implemented a quasi-experimental design with a convenience sample of 144 patients with DM undergoing CABG surgery at a major hospital in Amman, Jordan. Participants were randomly assigned to either a tight glycemic control group (n=72) or a conventional glycemic control group (n=72). Patients who received the tight glycemic control protocol had significantly more consistent and lower mean intraoperative BG levels than those who received the conventional glycemic control protocol. The tight glycemic control protocol resulted in significantly lower BG levels and fewer variations across each time-point and more consistent and stable BG levels than the conventional glycemic control protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Drug: Continuous insulin infusion |
Who may qualify
- Ages
- 43 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult Jordanian patients
- diagnosed with DM
- who had been scheduled to CABG surgery
Key exclusion criteria (1 listed)
- Participants who were immunosuppressed were excluded from the study.
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 insulin infusionThis study aims to explore the hypothesis that diabetic patients undergoing coronary artery bypass graft (CABG) surgery receiving intravenous continuous insulin infusion (CII) for tight glycemic control (110-149 mg/dl) protocol during the intraoperative period would have improved intraoperative glycemic stability, efficacy and consistency compared to patients receiving conventional glycemic control (150-180 mg/dl) protocol during the intraoperative period | Drug | Interventional |
Primary outcome
Intraoperative glycemic instability
Time frame: every half hour for eight hours
Intraoperative glycemic instability is defined as three consecutive readings of intraoperative blood glucose (BG) levels outside the pre-set targeted ranges of the protocols, whether higher or lower than the limits
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 30 Jun 2020.
- Background: PubMed 26138777Boreland L, Scott-Hudson M, Hetherington K, Frussinetty A, Slyer JT. The effectiveness of tight glycemic control on decreasing surgical site infections and readmission rates in adult patients with diabetes undergoing cardiac surgery: A systematic review. Heart Lung. 2015 Sep-Oct;44(5):430-40. doi: 10.1016/j.hrtlng.2015.06.004. Epub 2015 Jun 29.
- Background: PubMed 25825261Ogawa S, Okawa Y, Sawada K, Goto Y, Yamamoto M, Koyama Y, Baba H, Suzuki T. Continuous postoperative insulin infusion reduces deep sternal wound infection in patients with diabetes undergoing coronary artery bypass grafting using bilateral internal mammary artery grafts: a propensity-matched analysis. Eur J Cardiothorac Surg. 2016 Feb;49(2):420-6. doi: 10.1093/ejcts/ezv106. Epub 2015 Mar 29.
- Background: PubMed 27901264de Vries FE, Gans SL, Solomkin JS, Allegranzi B, Egger M, Dellinger EP, Boermeester MA. Meta-analysis of lower perioperative blood glucose target levels for reduction of surgical-site infection. Br J Surg. 2017 Jan;104(2):e95-e105. doi: 10.1002/bjs.10424. Epub 2016 Nov 30.
- Background: PubMed 22336691Hua J, Chen G, Li H, Fu S, Zhang LM, Scott M, Li Q. Intensive intraoperative insulin therapy versus conventional insulin therapy during cardiac surgery: a meta-analysis. J Cardiothorac Vasc Anesth. 2012 Oct;26(5):829-34. doi: 10.1053/j.jvca.2011.12.016. Epub 2012 Feb 14.
- BackgroundWahby, Ehab A, Elnasr M. M. Abo, Michael I. Eissa, and Sahbaa M. Mahmoud.
- Background: PubMed 17310047Gandhi GY, Nuttall GA, Abel MD, Mullany CJ, Schaff HV, O'Brien PC, Johnson MG, Williams AR, Cutshall SM, Mundy LM, Rizza RA, McMahon MM. Intensive intraoperative insulin therapy versus conventional glucose management during cardiac surgery: a randomized trial. Ann Intern Med. 2007 Feb 20;146(4):233-43. doi: 10.7326/0003-4819-146-4-200702200-00002.
- Background: PubMed 25572505Greco G, Shi W, Michler RE, Meltzer DO, Ailawadi G, Hohmann SF, Thourani VH, Argenziano M, Alexander JH, Sankovic K, Gupta L, Blackstone EH, Acker MA, Russo MJ, Lee A, Burks SG, Gelijns AC, Bagiella E, Moskowitz AJ, Gardner TJ. Costs associated with health care-associated infections in cardiac surgery. J Am Coll Cardiol. 2015 Jan 6;65(1):15-23. doi: 10.1016/j.jacc.2014.09.079.
- Background: PubMed 15006999Lazar HL, Chipkin SR, Fitzgerald CA, Bao Y, Cabral H, Apstein CS. Tight glycemic control in diabetic coronary artery bypass graft patients improves perioperative outcomes and decreases recurrent ischemic events. Circulation. 2004 Mar 30;109(12):1497-502. doi: 10.1161/01.CIR.0000121747.71054.79. Epub 2004 Mar 8.
- Background: PubMed 10030790Benneyan JC. Use and interpretation of statistical quality control charts. Int J Qual Health Care. 1998 Feb;10(1):69-73. doi: 10.1093/intqhc/10.1.69. No abstract available.
- Background: PubMed 24070959Canadian Diabetes Association Clinical Practice Guidelines Expert Committee; Imran SA, Rabasa-Lhoret R, Ross S. Targets for glycemic control. Can J Diabetes. 2013 Apr;37 Suppl 1:S31-4. doi: 10.1016/j.jcjd.2013.01.016. Epub 2013 Mar 26. No abstract available.
- Background: PubMed 21163498Bhamidipati CM, LaPar DJ, Stukenborg GJ, Morrison CC, Kern JA, Kron IL, Ailawadi G. Superiority of moderate control of hyperglycemia to tight control in patients undergoing coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2011 Feb;141(2):543-51. doi: 10.1016/j.jtcvs.2010.10.005. Epub 2010 Dec 15.
- BackgroundFinfer, S, DR Chittock, SY Su, D Blair, D Foster, V Dhingra, R Bellomo, D Cook, P Dodek, WR Henderson, PC Hébert, S Heritier, DK Heyland, C McArthur, E McDonald, I Mitchell, JA Myburgh, R Norton, J Potter, BG Robinson, and JJ Ronco.
- Individual participant dataSharing planned: No
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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?
A study testing Continuous insulin infusion in people with Blood Glucose, run by Audai A. Hayajneh at 1 site in Jordan.
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 3 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 30 Jun 2020. 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 Jordan. 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?
Intraoperative glycemic instability (time frame: every half hour for eight hours). 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 NCT04451655, which also lists 15 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 30 Jun 2020.