<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04451655</url>
  </required_header>
  <id_info>
    <org_study_id>JUST20180441</org_study_id>
    <nct_id>NCT04451655</nct_id>
  </id_info>
  <brief_title>Glycemic Stability During the Intraoperative Period Among Patients With DM Undergoing CABG Surgery</brief_title>
  <official_title>Glycemic Stability During the Intraoperative Period Among Patients With DM Undergoing CABG Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Audai A. Hayajneh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jordan University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives: Intraoperative glycemic stability and control among patients with diabetes&#xD;
      mellitus (DM) undergoing coronary artery bypass grafting (CABG) surgery remains a significant&#xD;
      concern. In this study, the intraoperative glycemic stability among diabetic patients&#xD;
      undergoing CABG surgery was compared between patients who received an intravenous continuous&#xD;
      insulin infusion (CII) for tight glycemic control with those who received an CII for&#xD;
      conventional glycemic control, during the intraoperative period.&#xD;
&#xD;
      Research Design and Methods: This study implemented a quasi-experimental design with a&#xD;
      convenience sample of 144 patients with DM undergoing CABG surgery at a major hospital in&#xD;
      Amman, Jordan.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives: Intraoperative glycemic stability and control among patients with diabetes&#xD;
      mellitus (DM) undergoing coronary artery bypass grafting (CABG) surgery remains a significant&#xD;
      concern. In this study, the intraoperative glycemic stability among diabetic patients&#xD;
      undergoing CABG surgery was compared between patients who received an intravenous continuous&#xD;
      insulin infusion (CII) for tight glycemic control with those who received an CII for&#xD;
      conventional glycemic control, during the intraoperative period.&#xD;
&#xD;
      Research Design and Methods: This study implemented a quasi-experimental design with a&#xD;
      convenience sample of 144 patients with DM undergoing CABG surgery at a major hospital in&#xD;
      Amman, Jordan. Participants were randomly assigned to either a tight glycemic control group&#xD;
      (n=72) or a conventional glycemic control group (n=72). Patients who received the tight&#xD;
      glycemic control protocol had significantly more consistent and lower mean intraoperative BG&#xD;
      levels than those who received the conventional glycemic control protocol. The tight glycemic&#xD;
      control protocol resulted in significantly lower BG levels and fewer variations across each&#xD;
      time-point and more consistent and stable BG levels than the conventional glycemic control&#xD;
      protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intraoperative glycemic instability</measure>
    <time_frame>every half hour for eight hours</time_frame>
    <description>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</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Blood Glucose</condition>
  <arm_group>
    <arm_group_label>Interventional</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Continuous insulin infusion</intervention_name>
    <description>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</description>
    <arm_group_label>Interventional</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult Jordanian patients&#xD;
&#xD;
          -  diagnosed with DM&#xD;
&#xD;
          -  who had been scheduled to CABG surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who were immunosuppressed were excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>43 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jordan royal medical service</name>
      <address>
        <city>Amman</city>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>26138777</PMID>
  </reference>
  <reference>
    <citation>Ogawa 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.</citation>
    <PMID>25825261</PMID>
  </reference>
  <reference>
    <citation>de 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.</citation>
    <PMID>27901264</PMID>
  </reference>
  <reference>
    <citation>Hua 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.</citation>
    <PMID>22336691</PMID>
  </reference>
  <reference>
    <citation>Wahby, Ehab A, Elnasr M. M. Abo, Michael I. Eissa, and Sahbaa M. Mahmoud.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17310047</PMID>
  </reference>
  <reference>
    <citation>Greco 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.</citation>
    <PMID>25572505</PMID>
  </reference>
  <reference>
    <citation>Lazar 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.</citation>
    <PMID>15006999</PMID>
  </reference>
  <reference>
    <citation>Benneyan 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.</citation>
    <PMID>10030790</PMID>
  </reference>
  <reference>
    <citation>Canadian 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.</citation>
    <PMID>24070959</PMID>
  </reference>
  <reference>
    <citation>Bhamidipati 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.</citation>
    <PMID>21163498</PMID>
  </reference>
  <reference>
    <citation>Finfer, 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.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16905513</PMID>
  </reference>
  <reference>
    <citation>Umpierrez 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.</citation>
    <PMID>26180108</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Jordan University of Science and Technology</investigator_affiliation>
    <investigator_full_name>Audai A. Hayajneh</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04451655
org study id: JUST20180441
nct id: NCT04451655
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Intraoperative glycemic instability
time frame: every half hour for eight hours
description: 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
arm group label: Interventional
arm group type: Experimental
intervention type: Drug
intervention name: Continuous insulin infusion
description: 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
arm group label: Interventional
criteria: 
gender: All
minimum age: 43 Years
maximum age: 74 Years
healthy volunteers: No
facility: 
country: Jordan
citation: 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.
PMID: 26138777
citation: Ogawa 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.
PMID: 25825261
citation: de 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.
PMID: 27901264
citation: Hua 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.
PMID: 22336691
citation: Wahby, Ehab A, Elnasr M. M. Abo, Michael I. Eissa, and Sahbaa M. Mahmoud.
citation: 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.
PMID: 17310047
citation: Greco 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.
PMID: 25572505
citation: Lazar 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.
PMID: 15006999
citation: Benneyan 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.
PMID: 10030790
citation: Canadian 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.
PMID: 24070959
citation: Bhamidipati 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.
PMID: 21163498
citation: Finfer, 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.
citation: 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.
PMID: 16905513
citation: Umpierrez 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.
PMID: 26180108
responsible party type: Sponsor-Investigator
investigator affiliation: Jordan University of Science and Technology
investigator full name: Audai A. Hayajneh
investigator title: Assistant professor
mesh term: Insulin
sharing ipd: No