Boreland L, Scott-Hudson M, Hetherington K, Frussinetty A, Slyer JT The effectiveness of tight glycemic control on decreasing surgical site infections and readmission rates in adult patients with diabetes undergoing cardiac surgery: A systematic review. Heart Lung. 2015 Sep-Oct;44(5):430-40. doi: 10.1016/j.hrtlng.2015.06.004. Epub 2015 Jun 29. Review.
Furnary AP, Wu Y Clinical effects of hyperglycemia in the cardiac surgery population: the Portland Diabetic Project. Endocr Pract. 2006 Jul-Aug;12 Suppl 3:22-6.
Hua J, Chen G, Li H, Fu S, Zhang LM, Scott M, Li Q Intensive intraoperative insulin therapy versus conventional insulin therapy during cardiac surgery: a meta-analysis. J Cardiothorac Vasc Anesth. 2012 Oct;26(5):829-34. doi: 10.1053/j.jvca.2011.12.016. Epub 2012 Feb 14.
Imran, S A., Rabasa-Lhoret, R & Ross, S. Targets for Glycemic Control. Canadian Journal of Diabetes, 2013. 40(1), 7-10. https://doi.org/10.1016/j.jcjd.2016.04.008
Lazar HL, Chipkin SR, Fitzgerald CA, Bao Y, Cabral H, Apstein CS Tight glycemic control in diabetic coronary artery bypass graft patients improves perioperative outcomes and decreases recurrent ischemic events. Circulation. 2004 Mar 30;109(12):1497-502. Epub 2004 Mar 8.
Ogawa S, Okawa Y, Sawada K, Goto Y, Yamamoto M, Koyama Y, Baba H, Suzuki T Continuous postoperative insulin infusion reduces deep sternal wound infection in patients with diabetes undergoing coronary artery bypass grafting using bilateral internal mammary artery grafts: a propensity-matched analysis. Eur J Cardiothorac Surg. 2016 Feb;49(2):420-6. doi: 10.1093/ejcts/ezv106. Epub 2015 Mar 29.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
