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Trial · Interventional

TerminatedPhase 4Results postedRegistry data

Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients

NCTNCT03743025 (opens ClinicalTrials.gov in a new tab)Other idIRB00097963Other id1K23GM128221-01A1
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 4
Enrollment
28 participants (actual)
Sponsor
Emory University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
8 Mar 2019
Primary completion
2 May 2023
Completion
2 May 2023
First posted
15 Nov 2018
Last update posted
30 May 2024
Conditions
Stress Hyperglycemia

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021202220232024
  1. Ph 4

    Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients

    NCT03743025

    8 Mar 2019 to 2 May 2023

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study is a prospective randomized study to examine the effects of exposure to dulaglutide on the prevention of stress-hyperglycemia and the metabolic inflammatory response in the perioperative period.

Interventions

  • Dulaglutide InjectionDrug
  • Saline InjectionOther

Arms2

  • Experimental

    Dulaglutide Arm

    Participants without a history of DM who are randomized to receive a single injection of dulaglutide (0.75 mg/0.5 mL solution in a single-dose pen) one to three days prior to surgery.

  • Placebo comparator

    Placebo Arm

    Participants without a history of DM who are randomized to receive a single injection of a placebo (saline injection of 0.5 mL pre-drawn solution) one to three days prior to surgery.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With Blood Glucose Levels (BG) > 140 mg/dl During Post Operative Period

    Time frame · During the hospital stay (up to 12 days postoperatively)

    Registry description

    Stress-hyperglycemia is defined as any post-CABG hospital-obtained blood glucose (BG) levels \>140 milligrams per deciliter (mg/dL). Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards.

Secondary outcomes(18)

  1. Mean Blood Glucose Levels During the Intensive Care Unit (ICU) Stay Postoperatively

    Time frame · During the ICU stay (up to 7 days postoperatively)

    Registry description

    To measure glucose control, the mean blood glucose levels in mg/dL were measured during the postoperative Intensive Care Unit (ICU) stay. Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards.

  2. Number of Participants Needing CII Treatment in the ICU

    Time frame · During the ICU stay (up to 7 days postoperatively)

    Registry description

    Patients with two consecutive BG \>180 mg/dl, or average daily BG \>180 mg/dl were started on rescue therapy with subcutaneous basal insulin (glargine or levemir) once daily. Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards. The number of participants needing CII while in the ICU postoperatively was compared between patients randomized to dulaglutide or placebo study arms.

  3. Number of Participants With Stress-hyperglycemia Requiring Rescue Therapy With Subcutaneous Insulin After Discontinuation of CII

    Time frame · During the hospital stay (up to 12 days postoperatively)

    Registry description

    Patients with two consecutive BG \>180 mg/dl, or an average daily BG \>180 mg/dl were started on rescue therapy with subcutaneous basal insulin (glargine or levemir) once daily. Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards. The number of participants in need of rescue therapy with subcutaneous insulin postoperatively, after CII was discontinued, was compared between study arms.

  4. Mean Blood Glucose Levels During the Hospital Stay

    Time frame · During the hospital stay (up to 12 days postoperatively)

    Registry description

    To measure glucose control, the mean blood glucose levels in mg/dL during the non-ICU hospital stay postoperatively were measured. Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards.

  5. Mean Units Per Hour of Insulin While in the ICU

    Time frame · During the ICU stay (up to 7 days postoperatively)

    Registry description

    The mean insulin dose during the time that participants were in the ICU is assessed as insulin infusion units per hour.

  6. Mean Insulin Dose Per Day While in the ICU

    Time frame · During the ICU stay (up to 7 days postoperatively)

    Registry description

    The mean insulin dose during the time that participants were in the ICU is assessed as insulin units per day.

  7. Duration of Continuous Insulin Infusion (CII)

    Time frame · During the hospital stay (up to 12 days postoperatively)

    Registry description

    The duration of continuous insulin infusion (CII) is assessed in hours.

  8. Days of Subcutaneous (SC) Insulin After Discontinuation of CII

    Time frame · During the hospital stay (up to 12 days postoperatively)

    Registry description

    Subcutaneous (SC) insulin use after continuous insulin infusion (CII) is discontinued is assessed as the number of days that SC insulin was required.

  9. Amount of SC Insulin Administered

    Time frame · During the hospital stay (up to 12 days postoperatively)

    Registry description

    The amount of subcutaneous (SC) insulin administered during the ICU and non-ICU hospital stay, among participants requiring SC insulin after discontinuing CII.

  10. Number of Participants Experiencing Hyperglycemic Events

    Time frame · During the hospital stay (up to 12 days postoperatively)

    Registry description

    Hyperglycemic events are defined as BG \> 200 mg/dl, during ICU and non-ICU hospital stay.

  11. Number of Participants Experiencing Hypoglycemic Events

    Time frame · During the hospital stay (up to 12 days postoperatively)

    Registry description

    Hypoglycemic events are defined as BG \<70, \< 54, and \<40 mg/dl occurring during ICU and non-ICU hospital stay.

  12. Number of Participants Experiencing Mortality and Complications

    Time frame · During the hospital stay (up to 12 days postoperatively)

    Registry description

    The number of participants experiencing a composite of mortality and complications. Complications include sternal wound infection, bacteremia, pneumonia, acute kidney injury, and acute myocardial infarction.

  13. Number of Participants Experiencing Gastrointestinal Adverse Events

    Time frame · During the hospital stay (up to 12 days postoperatively)

    Registry description

    The number participants who experienced gastrointestinal adverse events of nausea, vomiting, ileus, pancreatitis.

  14. ICU Length of Stay

    Time frame · During the ICU stay (up to 7 days postoperatively)

    Registry description

    ICU length of stay is assessed as the mean number of days participants in each study arm spent in the ICU.

  15. Hospital Length of Stay

    Time frame · During the hospital stay (up to 12 days postoperatively)

    Registry description

    Hospital length of stay is assessed as the mean number of days participants in each study arm spent in the hospital.

  16. Number of ICU Readmissions

    Time frame · During the hospital stay (up to 12 days postoperatively)

    Registry description

    The number of readmissions to the ICU.

  17. Number of Cerebrovascular Events

    Time frame · During the hospital stay (up to 12 days postoperatively)

    Registry description

    The number of cerebrovascular events.

  18. Participant Mortality

    Time frame · During the hospital stay (up to 12 days postoperatively)

    Registry description

    The number of participant deaths while in the ICU and hospital.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· During the hospital stay (up to 12 days postoperatively)

Number of Participants With Blood Glucose Levels (BG) > 140 mg/dl During Post Operative Period

GroupValue (Participants)
Dulaglutide11
Placebo13
Secondary and other outcome results(7)
Secondary outcomeMean· During the ICU stay (up to 7 days postoperatively)

Mean Blood Glucose Levels During the Intensive Care Unit (ICU) Stay Postoperatively

GroupValue (mg/dL)Spread
Dulaglutide134.1114.00
Placebo129.7911.42
Secondary outcomeCount of participants· During the ICU stay (up to 7 days postoperatively)

Number of Participants Needing CII Treatment in the ICU

GroupValue (Participants)
Dulaglutide11
Placebo12
Secondary outcomeCount of participants· During the hospital stay (up to 12 days postoperatively)

Number of Participants With Stress-hyperglycemia Requiring Rescue Therapy With Subcutaneous Insulin After Discontinuation of CII

GroupValue (Participants)
Dulaglutide6
Placebo4
Secondary outcomeMean· During the hospital stay (up to 12 days postoperatively)

Mean Blood Glucose Levels During the Hospital Stay

GroupValue (mg/dL)Spread
Dulaglutide119.6923.50
Placebo117.6920.59
Secondary outcomeMean· During the ICU stay (up to 7 days postoperatively)

Mean Units Per Hour of Insulin While in the ICU

GroupValue (insulin units/hour)Spread
Dulaglutide2.892.60
Placebo2.010.98
Secondary outcomeMean· During the ICU stay (up to 7 days postoperatively)

Mean Insulin Dose Per Day While in the ICU

GroupValue (insulin units/day)Spread
Dulaglutide61.1566.84
Placebo33.0120.19
Secondary outcomeMean· During the hospital stay (up to 12 days postoperatively)

Duration of Continuous Insulin Infusion (CII)

GroupValue (hours)Spread
Dulaglutide18.905.60
Placebo16.696.31

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
DulaglutideParticipants without a history of DM who were randomized to receive a single injection of dulaglutide (0.75 mg/0.5 mL solution in a single-dose pen) one to three days prior to surgery.0 / 121 / 124 / 12
PlaceboParticipants without a history of DM who were randomized to receive a single injection of a placebo (saline injection of 0.5 mL pre-drawn solution) one to three days prior to surgery.0 / 130 / 132 / 13

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Males or females between the ages of 40 and 80 years * Body mass index (BMI) ≥25 * Undergoing elective CABG surgery * No previous history of diabetes or hyperglycemia Exclusion Criteria: * Hyperglycemia (BG\>125 mg/dl or HbA1c \> 6.5%) or previous treatment with antidiabetic agents * Impaired renal function (GFR \< 30 ml/min) or clinically significant hepatic failure * Gastrointestinal obstruction expected to require gastrointestinal suction * Patients with clinically relevant pancreatic or gallbladder disease * Treatment with oral or injectable corticosteroid * Mental condition rendering the subject unable to understand the possible consequences of the study * Pregnancy or breastfeeding at time of enrollment

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