NCT00871832

Brief Summary

It is currently standard of care in many Medical and Surgical ICU's to institute a nurse driven insulin protocol in maintaining tight glucose control in the critical patient. Many articles have been written to address this topic. However, there is no current data regarding the use of glycohemoglobin as a marker of risk of morbidity and mortality. In our study we would like to determine whether or not the HbA1C could be used as a marker of morbidity and mortality. The HbA1C is a simple blood test that may be added on to any CBC collection tube; a blood sample that critical patients have drawn up to several times a day. The investigators would analyze this information in respect to the rest of the clinical data collected regarding the patient's illness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2007

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

May 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

June 6, 2013

Status Verified

June 1, 2013

Enrollment Period

2.8 years

First QC Date

March 26, 2009

Last Update Submit

June 5, 2013

Conditions

Hyperglycemia

Keywords

hyperglycemiaHgA1cmortality

Outcome Measures

Primary Outcomes (1)

  • morbidity and mortality

    looking to see if HbA1C correlates with morbidity (i.e. sepsis, renal failure, length of stay) or death

    at time of review

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted to the medical and surgical ICU, and CCU that are 18 year's or older and speak English that give consent.

You may qualify if:

  • All patients admitted to the medical and surgical ICU, and CCU that are 18 year's or older and speak English that give consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Mario Castellanos, MD

    Staten Island University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Director of Research, Dept. of Medicine

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 30, 2009

Study Start

May 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

June 6, 2013

Record last verified: 2013-06

Locations

US(1)