- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01361594
Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery (CABG)
18. prosince 2014 aktualizováno: Guillermo Umpierrez, Emory University
High blood glucose levels (hyperglycemia) in cardiac surgery patients with diabetes are associated with increased risk of hospital complications.
Blood sugar control with intravenous insulin may prevent such hospital complications.
Many patients undergoing cardiac bypass surgery (CABG) develop high blood sugars and require insulin therapy (shortly before or after surgery).
It is not clear what the best insulin regimen is or what is the best blood sugar target in these patients.
Accordingly, this research study aims to determine optimal blood glucose levels during the in patients undergoing cardiac bypass surgery.
Patients will be divided in two groups.
The intensive insulin group will be maintained at blood glucose between 100-140 mg/dl and the conventional treatment group at a glucose level between 140-180 mg/dl.
The insulins to be used in this trial (lantus, aspart and regular insulin) are approved for use in the treatment of patients with diabetes by the FDA (Food and Drug Administration).
A total of 326 patients with high blood glucose after cardiac bypass surgery will be recruited in this study.
Patients will be recruited at Emory University Hospital, Emory Midtown Hospital and Grady Memorial Hospital.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
Several prospective cohort studies as well as randomized clinical trials (RCT) in cardiac surgery patients have shown that intensified insulin therapy (target BG: 110-140 mg/dl) results in a reduction in short- and long-term mortality compared with conventionally treated patients.
The results of recent international trials in critically ill patients; however, have failed to show a significant improvement in mortality or have even shown increased mortality risk as well as increased number of hypoglycemic events with intensive compared to less intensive glycemic control.
Based on the results of these ICU trials, new ADA and AACE guidelines recommended a glycemic target between 140 and 180 mg/dl in the ICU including cardiac surgery patients.
There is concern that such high BG targets might increase the risk of hospital complications in cardiac surgical patients in whom intensive glucose control has consistently reduced infections, length of hospital stay, resource utilization, and cardiac-related mortality.
The overall objective of this proposal is to conduct the first prospective RCT to determine the optimal BG target during the perioperative period in hyperglycemic subjects who undergo CABG in the United States.
Subjects will be randomized to undergo intensive insulin therapy adjusted to maintain a BG between 100 mg/dl and 140 mg/dl or to a conventional glucose control with a target BG between 141 mg/dl and 200 mg/dl in the ICU.
The central hypothesis of this proposal is that intensive insulin management will reduce perioperative complications compared to a conventional BG control in cardiac surgery patients.
Typ studie
Intervenční
Zápis (Aktuální)
338
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Georgia
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Atlanta, Georgia, Spojené státy, 30326
- Emory University Hospital
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 80 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Males or females between the ages of 18 and 80 years undergoing CABG +/- valve surgery.
- Post surgical hyperglycemia (BG > 140 mg/dl).
- Patients with and without a history of type 2 diabetes
Exclusion Criteria:
- Patients requiring combination CABG with additional procedures such aorta replacement.
- Patients with severely impaired renal function (serum creatinine ≥3.0 mg/dl or GFR < 30 ml/min) or clinically significant hepatic failure.
- Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.
- Moribund patients and those at imminent risk of death (brain death or cardiac standstill).
- Patients or next-to-kin with mental condition rendering the subject or family member unable to understand the nature, scope, and possible consequences of the study.
- Female subjects who are pregnant or breast-feeding at time of enrollment into the study.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
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 |
|---|---|
|
Aktivní komparátor: Intensive insulin treatment
Intensive insulin treatment (BG target: 100-140 mg/dL)
|
Titration of the IV insulin rate for glucose goal 100-140 mg/dL
|
|
Aktivní komparátor: Conventional insulin treatment
Conventional insulin treatment (BG target: 141-180 mg/dl)
|
Titration of the IV insulin rate for glucose goal 141-180 mg/dl
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Subjects That Were Diagnosed for Peri-operative Complications
Časové okno: Within 6 months of hospitalization
|
Number of participants that presented at least 1 complications including sternal wound infection, bacteremia, acute renal failure, respiratory failure, and major cardiovascular events (MACE) during the current hospitalization and up to 6 months after hospitalization
|
Within 6 months of hospitalization
|
|
Hospital Mortality
Časové okno: average 1 month during the hospitalization
|
Mortality is defined as death occurring during admission, either during ICU or after transition to non-ICU admission.
|
average 1 month during the hospitalization
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Glycemic Control
Časové okno: average 1 month during the hospitalization
|
|
average 1 month during the hospitalization
|
|
Major Cardiovascular Events
Časové okno: average 1 month during the hospitalization
|
|
average 1 month during the hospitalization
|
|
Acute Renal Failure
Časové okno: average 1 month during the hospitalization
|
new-onset abnormal renal function: serum creatinine > 2.0 mg/dL or an increment level > 50% from baseline
|
average 1 month during the hospitalization
|
|
Respiratory Failure, Defined as PaO2 Value < 60 mm Hg While Breathing Air or a PaCO2 > 50 mm Hg.
Časové okno: average 1 month during the hospitalization
|
Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg.
|
average 1 month during the hospitalization
|
|
ICU and Hospital Length of Stay, and ICU Readmissions
Časové okno: average 1 month during the hospitalization
|
ICU and hospital length of stay, and ICU readmissions
|
average 1 month during the hospitalization
|
|
Surgical Wound Infection
Časové okno: average 1 month during the hospitalization
|
superficial and deep sternal wound infection
|
average 1 month during the hospitalization
|
|
Pneumonia (CDC Criteria)
Časové okno: average 1 month during the hospitalization
|
Pneumonia (CDC criteria)
|
average 1 month during the hospitalization
|
|
Cerebrovascular Events
Časové okno: average 1 month during the hospitalization
|
permanent stroke and reversible ischemic neurologic deficit.
|
average 1 month during the hospitalization
|
|
Duration of Ventilatory Support and ICU Readmission
Časové okno: average 1 month during the hospitalization
|
Duration of ventilatory support and ICU readmission
|
average 1 month during the hospitalization
|
|
Thirty Day Mortality
Časové okno: within 30 days of discharge
|
Thirty day mortality
|
within 30 days of discharge
|
|
Number of Hospital Readmissions and Emergency Room Visits
Časové okno: Within 30 days after discharge
|
Number of hospital readmissions and emergency room visits
|
Within 30 days after discharge
|
|
Incidence of Organ Failures Assessed by the Daily SOFA Score
Časové okno: average 1 month during the hospitalization
|
Incidence of organ failures assessed by the daily SOFA score
|
average 1 month during the hospitalization
|
|
Measures of Inflammation
Časové okno: average 1 month during the hospitalization
|
Measures of inflammation (C-reactive protein, TNF-alpha; IL-6) and oxidative stress markers
|
average 1 month during the hospitalization
|
|
Major Cardiovascular Events
Časové okno: within 3 months after discharge
|
|
within 3 months after discharge
|
|
Surgical Wound Infection
Časové okno: within 3 months after discharge
|
Superficial and deep sternal wound infection
|
within 3 months after discharge
|
|
Pneumonia (CDC Criteria)
Časové okno: Within 3 months after discharge
|
Pneumonia (CDC criteria)
|
Within 3 months after discharge
|
|
Cerebrovascular Events
Časové okno: within 3 months after discharge
|
permanent stroke and reversible ischemic neurologic deficit
|
within 3 months after discharge
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Guillermo E Umpierrez, MD, Emory University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. června 2011
Primární dokončení (Aktuální)
1. prosince 2013
Dokončení studie (Aktuální)
1. prosince 2013
Termíny zápisu do studia
První předloženo
3. února 2011
První předloženo, které splnilo kritéria kontroly kvality
26. května 2011
První zveřejněno (Odhad)
27. května 2011
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
31. prosince 2014
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. prosince 2014
Naposledy ověřeno
1. prosince 2014
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IRB00048356
- 00048356-2010 (Jiný identifikátor: Other)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .