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

NCT03526536 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-10-26

No results posted yet for this study

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

Interventions

DRUG

IV Novolin R human insulin

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

Sponsors & Collaborators

  • State University of New York - Downstate Medical Center

    lead OTHER

Principal Investigators

  • Ketan Shevde, MD · State University of New York - Downstate Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2020-09-03
Completion
2020-09-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03526536 on ClinicalTrials.gov