Clinical trial NCT00812487: Glycemic Control and Variability for Congestive Heart Failure Exacerbation
Official title: Glycemic Control and Variability for Congestive Heart Failure Exacerbation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Congestive Heart Failure
Diabetes Mellitus
Keywords: congestive heart failure
diabetes mellitus
hyperglycemia
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-12-22
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High glucose as well as fluctuations (rapid swings) in blood glucose can contribute to severe hospital complications and even death.

Detailed description: High glucose as well as fluctuations in blood glucose can contribute to severe hospital complications and even death. Studies also suggest that heart failure patients who have high glucose or diabetes do not live as long as patients with normal glucose. Glucose fluctuations have not been well-studied in patients with heart failure. In this study, we will determine whether better control of blood sugar fluctuations in the hospital improve outcomes. We will enroll 80 patients with severe heart failure and divide them into 2 groups. We will use intravenous (given through the vein) insulin to lower blood sugar levels in group 1, and insulin injections (under the skin) in group 2. We will determine whether intravenous insulin improves blood markers of inflammation, changes in vital signs, and other tests that predict mortality in patients with heart failure.

Eligibility criteria: Inclusion Criteria:

* Age 18 and above
* Admitted (less than 48 hours) to the with worsening heart failure
* Hyperglycemia or diabetes. Hyperglycemia is defined as blood glucose greater than 150 mg/dL on at least 2 occasions separated by at least 4 hours apart, insulin use, or HbA1c \>6.5%.

Exclusion Criteria:

* Type 1 diabetes
* Receiving comfort care measures only
* Hospital stay expected to be less than 2 days
* Pregnancy
* Prisoners
* Participation in the study on prior hospitalizations
* Acute myocardial infarction within 3 months
* End stage renal or liver disease

Primary outcomes:
measure: Hospital Length of Stay
timeFrame: participants were followed for the duration of hospital stay, median hospital stay 8 day
measure: Hospital Readmission
timeFrame: 30 days
Secondary outcomes:
measure: High Frequency Heart Rate Variability
timeFrame: 24 hours
measure: Pre-ejection Period (PEP)
timeFrame: 24 hours
measure: High Sensitivity C-reactive Protein (Hs-CRP)
timeFrame: 72 hours
measure: Brain Natriuretic Peptide (BNP)
timeFrame: 72 hours
measure: Quality of Life
timeFrame: 30 days
measure: Glycemic Lability Index (GLI)
timeFrame: 24 hours
measure: Coefficient of Variation (CV)
timeFrame: 24 hours
measure: Mean Glucose
timeFrame: 24 hours
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Kathleen M Dungan, MD
role: PRINCIPAL_INVESTIGATOR
References: