Pre-admission Hyperglycemia and Its Effect on Morbidity a... | NCT00871832

Studies
Pre-admission Hyperglycemia and Its Effect on Morbidity and Mortality

NCT00871832

Sponsor

Northwell Health

Status

Completed

Last Update Posted

Jun 6, 2013Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Hyperglycemia

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Mar 26, 2009

First Submission Date that Met QC Criteria

Mar 27, 2009

First Posted Date

Mar 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2013

Last Update Posted Date

Jun 6, 2013Estimated

Name	Class
Staten Island University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mario Castellanos, MD	Staten Island University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Staten Island University Hospital		Staten Island	New York	10305	United States

Condition Browse Module

MeSH Terms

ID	Term
D006943	Hyperglycemia

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided