Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DK080891-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients with heart failure often have high blood sugar (glucose).
Patients with heart failure often have high blood sugar. High glucose contributes to severe hospital complications and even death. Studies suggest that heart failure patients who have high glucose or diabetes do not live as long as patients with normal glucose. In this study, we will determine whether normalizing blood sugars using intravenous insulin short-term will improve outcomes in patients hospitalized for congestive heart failure. We enrolled patients with severe heart failure and randomly assigned them into 2 groups. We used intravenous (given through the vein) insulin to lower blood sugar levels in group 1, and insulin injections in group 2. We determined whether intravenous insulin improved hospital length of stay, rates of readmission, inflammatory markers, and cardiovascular tests that predict mortality in patients with heart failure.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Insulin | Experimental |
| |
| Subcutaneous Insulin | Active Comparator | Basal bolus insulin (4 injections per day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous insulin | Drug | Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | Duration of hospitalization in days | Days |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Readmission | All-cause hospital readmission at 30 days after discharge | 30 days |
| Heart Rate Variability | High frequency (HF) Heart rate variability (HRV). HRV was assessed with a Bionex system (Mindware, Gahanna, OH). The electrocardiogram was performed in the standard lead II configuration and impedance cardiography was performed using a standard tetrapolar arrangement. Measures were performed at baseline and each morning (0800-1000 hour) during and following the intervention for 7 minutes each. Software (Mindware, Gahanna, OH) was used to derive HF HRV. The middle five minutes of the recordings were scored minute by minute and the first suitable1 minute period was used for calculation. Five minute epochs were not feasible due to an unexpectedly high frequency of ectopy. One minute intervals allow calculation of HF (parasympathetic tone) but not low frequency (combination of sympathetic and parasympathetic tone). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kathleen M Dungan, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Insulin (IV) | Intravenous insulin: In patients assigned to intravenous (IV) insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap. |
| FG001 | Subcutaneous Insulin | Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline population consists of patients with available study data.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous (IV) Insulin | Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hospital Length of Stay | Duration of hospitalization in days | Posted | Median | Inter-Quartile Range | days | Days |
|
72 hours after enrollment
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous (IV) Insulin | Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Endocrine disorders | Systematic Assessment | Hypoglycemia defined as a blood glucose value 3.9\ |
HRV and impedance data were limited due to medical devices, conditions that preclude measurement of HRV such as arrhythmias, or technical problems (N=2). The remainder of missing data were due to early hospital discharge.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Dungan | The Ohio State University | 6146853333 | kathleen.dungan@osumc.edu |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D003920 | Diabetes Mellitus |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Subcutaneous insulin | Drug | Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day. |
|
| 72 hours |
| Change in Quality of Life | Change in Quality of Life questionnaire measured from baseline (enrollment) to 30 days following discharge. The questionnaire is a self-administered disease-specific questionnaire for patients with HF, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on health related quality of life, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL), | 30 day |
| Brain Natriuretic Peptide (BNP) | Brain natriuretic peptide (BNP) was measured at day 3 | 72 hours |
| Cardiac Output | Cardiac output measured using impedance cardiography at 72 hours. | 72 hours |
| Lost to Follow-up |
|
| BG001 | Subcutaneous (SQ) Insulin | Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Preserved ejection fraction | Preserved ejection fraction was defined as greater than 50% | Number | participants |
|
| HbA1c | Mean | Standard Deviation | Percentage of hemoglobin |
|
Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
|
|
| Secondary | Hospital Readmission | All-cause hospital readmission at 30 days after discharge | Posted | Number | participants | 30 days |
|
|
|
| Secondary | Heart Rate Variability | High frequency (HF) Heart rate variability (HRV). HRV was assessed with a Bionex system (Mindware, Gahanna, OH). The electrocardiogram was performed in the standard lead II configuration and impedance cardiography was performed using a standard tetrapolar arrangement. Measures were performed at baseline and each morning (0800-1000 hour) during and following the intervention for 7 minutes each. Software (Mindware, Gahanna, OH) was used to derive HF HRV. The middle five minutes of the recordings were scored minute by minute and the first suitable1 minute period was used for calculation. Five minute epochs were not feasible due to an unexpectedly high frequency of ectopy. One minute intervals allow calculation of HF (parasympathetic tone) but not low frequency (combination of sympathetic and parasympathetic tone). | Subjects with medical devices, conditions that preclude measurement of HRV such as arrhythmias, or technical problems could not be analyzed. | Posted | Median | Inter-Quartile Range | ms^2 | 72 hours |
|
|
|
| Secondary | Change in Quality of Life | Change in Quality of Life questionnaire measured from baseline (enrollment) to 30 days following discharge. The questionnaire is a self-administered disease-specific questionnaire for patients with HF, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on health related quality of life, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL), | Posted | Mean | Standard Deviation | units on a scale | 30 day |
|
|
|
| Secondary | Brain Natriuretic Peptide (BNP) | Brain natriuretic peptide (BNP) was measured at day 3 | Posted | Median | Inter-Quartile Range | pg/ml | 72 hours |
|
|
|
| Secondary | Cardiac Output | Cardiac output measured using impedance cardiography at 72 hours. | Patients without data due to medical devices, conditions that preclude measurement of PEP such as arrhythmias, or technical problems. | Posted | Mean | Standard Deviation | liter/min | 72 hours |
|
|
|
| 0 |
| 26 |
| 9 |
| 26 |
| EG001 | Subcutaneous (SQ) Insulin | Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l. | 0 | 39 | 3 | 39 |
|
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |