NCT00589680

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2007

Shorter than P25 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

December 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

December 26, 2007

Last Update Submit

March 11, 2024

Conditions

Diabetic Ketoacidosis

Keywords

Acidosis, DiabeticDiabetic AcidosisDiabetic KetosisKetoacidosis, DiabeticKetosis, Diabetic

Outcome Measures

Primary Outcomes (1)

  • Hospital length of stay

    Time in hospital

Secondary Outcomes (3)

  • 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

    hospital stay

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \< 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Mary's Medical Center

Huntington, West Virginia, 25702, United States

Location

MeSH Terms

Conditions

Diabetic Ketoacidosis

Condition Hierarchy (Ancestors)

KetosisAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Sharon Jones, Pharm.D.

    St. Mary's Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Coordinator

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 10, 2008

Study Start

December 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

March 13, 2024

Record last verified: 2024-03

Locations

US(1)