Strict Glycemic Control by Insulin Infusion:Observations on Emergency Department Initiation

NCT00779701 | Completed Phase 4 Results

• 1 other identifier: TU10526
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Glycemic control can be safely achieved in surgical and medical intensive care unit settings and has been shown to improve short and long-term clinical outcomes. As such, insulin infusion protocols are routinely used in the ICU setting. The investigators plan to establish the use of strict glycemic control in a heterogenous group of acutely ill patients in the ED setting. The investigators propose to study the aspects of implementing a strict glycemic control protocol in the ED.

Conditions

Hyperglycemia

Keywords

Hyperglycemia; Glycemic control

Outcome Measures

Primary Outcomes (1)

• Time to Achieve Glycemic Control

  Study duration 6 hours. Blood glucose checked at 30 minutes then every 15 minutes until within target blood glucose range then every hour.

Study Arms (1)

A

OTHER

All subjects placed on insulin infusion.

Drug: Insulin

Interventions

Insulin DRUG

Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL

A

Eligibility Criteria

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

You may qualify if:

• Patients with blood glucose ≥130 mg% considered to be critically ill as defined by:
• APACHE II score ≥9 (See Appendix 1) OR \>2 SIRS criteria with lactate ≥ 4 or BP \< 90mmHg despite one liter of fluid OR Evidence of Organ Dysfunction (see Appendix 1)

You may not qualify if:

• Patients requiring urgent interventional procedure (e.g. cardiac catheterization, dialysis) or surgery performed outside of the ED.

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 191440, United States

Location

MeSH Terms

Conditions

Hyperglycemia

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Nina Gentile
• Organization: Temple University Hospital

ngentile@temple.edu

215-707-2000

Study Officials

• Nina T Gentile, MD

  Temple University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: October 24, 2008
• Study Start: March 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: March 16, 2017
• Results First Posted: June 9, 2015

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)