Compliance With American Diabetes Association Treatment G... | NCT00589680

Studies
Compliance With American Diabetes Association Treatment Guidelines for Adult Ketoacidosis

NCT00589680

Sponsor

Marshall University

Status

Completed

Last Update Posted

Mar 13, 2024Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Diabetic Ketoacidosis

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

Mar 2024

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

Dec 2007

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Dec 26, 2007

First Submission Date that Met QC Criteria

Jan 9, 2008

First Posted Date

Jan 10, 2008Estimated

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

Mar 11, 2024

Last Update Posted Date

Mar 13, 2024Actual

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

At this time, Saint Mary's Medical Center is currently in the process of implementing a standardized diabetic ketoacidosis (DKA) protocol. The first main goal of this project will be to evaluate patient outcomes to determine the effects of treating patients without a standardized protocol and to establish a baseline on how patients are being treating with DKA. The final goal of the project will be to compare outcomes of those patients not placed on the protocol to those that were treated using SMMC newly implemented DKA protocol. The overall goal of this project is to determine the benefit of an institutional DKA protocol.

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2		Patients treated for DKA under DKA protocol implemented by hospital
1		To establish a baseline on how patients are being treating with DKA in general and without a standardized DKA protocol

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospital length of stay		Time in hospital

Secondary Outcomes

Measure	Description	Time Frame
ICU length of stay		hospital stay
ICU length of stay Hypoglycemic events (BG<60)		hospital stay
Time to correction of glucose level and anion gap

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Admitted to St. Mary's Medical Center with DKA
>/= 18 years of age

Exclusion Criteria:

< 18 years of age

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Those patients admitted to St. Mary's Medical Center with a diagnosis of DKA.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sharon Jones, Pharm.D.	St. Mary's Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Mary's Medical Center		Huntington	West Virginia	25702	United States

Condition Browse Module

MeSH Terms

ID	Term
D016883	Diabetic Ketoacidosis

Ancestor Terms

ID	Term
D007662	Ketosis
D000138	Acidosis
D000137	Acid-Base Imbalance
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided