Pilot: Insulin Sensitivity/Management in Hyperglycemic Patients in Perioperative Period ESRD/Non-ESRD

Stopped early · Phase 4

Conditions studied: End-Stage Renal Disease, Diabetes Mellitus

In brief

This study is for people with diabetes who have either healthy kidneys or who have end stage renal disease (ESRD) and are on hemodialysis that are having surgery. This research will help increase our knowledge about how having diseased kidneys and being on hemodialysis changes how the body responds to insulin. In the time period directly before, during, and after surgery, maintenance of blood sugar within normal physiological range is essential. When patients come for surgery and have an elevated blood sugar, it is up to each individual physician to decide on the right amount of insulin to treat them. Currently, there are many different protocols across the country to treat elevated blood sugar; however, there is no one specific protocol to treat elevated blood sugar at SUNY Downstate Medical Center at this time. In this study, the investigators will evaluate the change in blood sugar following insulin administration to determine whether there is a significantly different response between ESRD and non-ESRD patients. The results of the study will help develop safer practice guidelines to patients with ESRD with an elevated blood sugar while they are having surgery.

Key facts

Study ID

NCT03526536

Run by

State University of New York - Downstate Medical Center

People needed

40

Starts

2018-05-01

Expected to finish

2020-09-03

Last updated by the study team

2020-10-26

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients over 18 years old with diabetes (both sexes) presenting without any kidney disease or with ESRD on hemodialysis
• Undergoing major elective surgery procedures such as abdominal, pulmonary, GU/GYN, vascular, renal, neurologic, and orthopedic surgery
• Signed informed consent for the study.
• Patients with elevated preoperative blood glucose of a value > 150 mg/dL or < 350 mg/dL
• English-speaking
• Baseline chemistry with a potassium at or above 3.5

You may not qualify if…

• Patients under the age of 18.
• Pregnant women. (Pregnant women have altered glucose metabolism; specific insulin regimen used for pregnant women)
• Patient does not give informed consent for the study.
• Patient does not have decisional capacity or a surrogate.
• Patient cannot understand or read English.
• Patients with a preoperative blood glucose < 150 mg/dL or >350 mg/dL
• Patients without diabetes
• Patients with kidney disease that are not on hemodialysis
• A history of frequent hypoglycemia in the month prior to surgery by history or a change in insulin dose for hypoglycemia in the month prior to surgery
• Patients taking steroids or patients that will receive steroids during their surgery
• Any patients who refuse to remain NPO except water in the two hour window after their last insulin dose
• Patients scheduled for cardiac, thoracic and emergency surgeries
• Patients who have taken or received insulin or oral hypoglycemic agents after 12 am on the day of surgery.
• Patients have not adhered to the NPO status.

Where it is running

• SUNY Downstate Medical Center — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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