- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00836329
Improving Neurologic Outcomes in People With Diabetes Who Are Undergoing Heart Surgery
Improving Neurologic Outcomes in Diabetics Undergoing Cardiac Surgery
Přehled studie
Postavení
Detailní popis
People with diabetes who undergo heart surgery have a greater risk of experiencing a stroke and developing cognitive functioning problems than people without diabetes who undergo heart surgery. There may be a connection between disturbances in glucose metabolism, endothelial dysfunction, and poor neurological outcomes after heart surgery. People with diabetes who receive more intensive blood glucose management during and after heart surgery may have better neurological outcomes than people who control their blood glucose levels in a standard way. The purpose of this study is to evaluate the effectiveness of using a traditional method of controlling blood glucose levels versus a tailored, more intensive method of glucose control on neurological outcomes in people with diabetes who are undergoing heart surgery. Researchers will also examine genetic factors that may be associated with insulin resistance and inflammation.
This study will enroll people undergoing heart surgery. On the day before surgery, participants will undergo a blood collection and neuropsychological testing. They will then be randomly assigned to either a traditional method of blood glucose control or an intensive, tailored method of blood glucose control. Participants following the traditional method of blood glucose control may receive insulin several times a day, based on the results of glucose monitoring. Participants following the intensive, tailored method of blood glucose control will undergo hourly measurements of their glucose levels and receive insulin adjustments as needed to maintain a glucose level of 100-140 mg/dL. During surgery, all participants will undergo an ultrasound of their neck to monitor blood vessel activity. Additional blood samples will be collected during surgery, 6 hours after surgery, 24 hours after surgery, and upon hospital discharge or 5 days after surgery.
One week after surgery or just before leaving the hospital, participants will undergo a magnetic resonance imaging (MRI) procedure and neuropsychological testing. Before leaving the hospital, participants will take part in a diabetes education session and nutrition counseling. Three to 6 weeks and 6 months after surgery, participants will undergo repeat neuropsychological testing. Once a month for 6 months, participants who received the intensive, tailored method of blood glucose control will attend study visits at which time study researchers will monitor their diabetes.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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North Carolina
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Winston-Salem, North Carolina, Spojené státy, 27057
- Wake Forest Baptist Medical Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- History of diabetes, elevated fasting blood glucose, elevated hemoglobin A1c, or elevation of these variables during the current hospital admission
- Scheduled to undergo coronary artery bypass graft (CABG) surgery
- Scheduled to undergo aortic valve replacement (AVR), mitral valve replacement (MVR), or both
- Scheduled to undergo valve replacement with CABG
Exclusion Criteria:
- Undergoing emergent (i.e., urgent) procedures
- Alzheimer's disease or similar dementias
- Severe claustrophobia
- Kidney insufficiency, as defined by serum creatine levels greater than 2.0 mg/dL
- Cannot be expected to complete neuropsychological testing
- Recent extensive, life threatening acute myocardial infarction (AMI)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Intensive Glucose Management
Participants will receive intensive glucose management.
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Participants in the intensive glucose management group will undergo strict management of their blood glucose levels with a target whole blood glucose level of 100-140 mg/dL preoperatively, intraoperatively, and postoperatively in the intensive care unit (ICU).
Once meals are started, targets for glycemia management will be (a) fasting: 80-140 mg/dL, (b) postprandial: 140-180 mg/dL.
Prior to hospital discharge, participants will receive an in-depth diabetes education session.
After hospital discharge, participants will attend monthly study visits for 6 months so that study researchers can monitor their glycemia management.
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Aktivní komparátor: Traditional Glucose Management
Participants will receive a traditional method of glucose management.
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Participants will receive traditional management of blood glucose levels while in the hospital.
They may receive insulin several times a day, based on the results of glucose monitoring.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Proportion of participants with identifiable brain lesions detected by magnetic resonance imaging (MRI)
Časové okno: Measured 1 week after surgery
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Measured 1 week after surgery
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Proportion of participants with new neuropsychological deficits (20% decline on two or more neuropsychological tests)
Časové okno: Measured 6 months after surgery
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Measured 6 months after surgery
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Number of lesions, as measured by MRI
Časové okno: Measured 1 week after surgery
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Measured 1 week after surgery
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Size of lesions, as measured by MRI
Časové okno: Measured 1 week after surgery
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Measured 1 week after surgery
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Genetic analysis (i.e., predictive utility of haplotype assignment on primary outcomes)
Časové okno: Measured 6 months after surgery
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Measured 6 months after surgery
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Neuropsychological deficits (i.e., predictive utility of neuropsychological performance on presence, number, and volume of lesions)
Časové okno: Measured 6 months after surgery
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Measured 6 months after surgery
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Edward H. Kincaid, MD, Wake Forest University Health Sciences
- Ředitel studie: Jorge Calles-Escandon, MD, Wake Forest University Health Sciences
- Ředitel studie: Donald W. Bowden, PhD, Wake Forest University Health Sciences
- Ředitel studie: David A. Stump, PhD, Wake Forest University Health Sciences
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 615
- R01HL089115-01 (Grant/smlouva NIH USA)
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