NCT00826007

Brief Summary

The purpose of the study is to review incidences of mild, moderate, and severe hypoglycemia in preoperative care units, operating rooms, and postanesthesia care units and analyze associated conditions and treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
587

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 27, 2013

Completed
Last Updated

May 27, 2013

Status Verified

March 1, 2013

Enrollment Period

2.5 years

First QC Date

January 19, 2009

Results QC Date

March 26, 2013

Last Update Submit

March 26, 2013

Conditions

DiabetesHypoglycemia

Keywords

perioperative hypoglycemia diabetes surgerysurgery

Outcome Measures

Primary Outcomes (1)

  • Hypoglycemia Incidence

    Blood glucose values \<70 mg/dl

    perioperative period

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgical patients

You may qualify if:

  • Patients who underwent surgery at William Beaumont Hospital in Royal Oak, Michigan between January 1, 2003, and January 1, 2009.
  • Point of care testing identified a blood sugar value less than 69 mg/dl at any time in the perioperative area; or a value between 70-89 mg/dl in the preoperative area; or a glucose value greater than 250 mg/dl in the preoperative area.

You may not qualify if:

  • Obstetric patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Biospecimen

Retention: NONE RETAINED

non applicable

MeSH Terms

Conditions

Diabetes MellitusHypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

Point-of-care blood glucose testing was most often the means of measurement. Frequency of glucose monitoring was not standardized. Retrospective review.

Results Point of Contact

Title
Tamra Dukatz, CRNA, MSN
Organization
William Beaumont Hospital
tdukatz@beaumont.edu
2489924741

Study Officials

  • Solomon I Rosenblatt, MD

    Michigan Endocrine Consultants

    PRINCIPAL INVESTIGATOR

  • Tamra Dukatz, CRNA

    Beaumont Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CRNA, Anesthesia Department

Study Record Dates

First Submitted

January 19, 2009

First Posted

January 21, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

May 27, 2013

Results First Posted

May 27, 2013

Record last verified: 2013-03

Locations

US(1)