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

NCT03526536 | Terminated Phase 4 FDA Drug

• 1 other identifier: 1114056
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End-Stage Renal Disease; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in blood glucose level

  Change in blood glucose level measures using a glucometer (Nova Biomedical, Waltham, MA. USA)

  one hour

Study Arms (2)

Patients with diabetes and ESRD

OTHER

Patients with diabetes and end stage renal disease (ESRD)

Drug: IV Novolin R human insulin

Patients with diabetes and no ESRD

OTHER

Patients with diabetes and no end stage renal disease (ESRD)

Drug: IV Novolin R human insulin

Interventions

IV Novolin R human insulin DRUG

Novolin R human insulin, Novo Nordisk Inc. Plainsboro, NJ

Also known as: Novolin R human insulin, Novo Nordisk Inc. Plainsboro, NJ

Patients with diabetes and ESRD; Patients with diabetes and no ESRD

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• State University of New York - Downstate Medical Center: lead

Study Sites (1)

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Related Publications (1)

• Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.

  PMID: 37526194 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ketan Shevde, MD

  State University of New York - Downstate Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; Professor of Clinical Anesthesia; Vice-Chair for Research

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 16, 2018
• Study Start: May 1, 2018
• Primary Completion: September 3, 2020
• Study Completion: September 3, 2020
• Last Updated: October 26, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)