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Compliance With American Diabetes Association Treatment Guidelines for Adult Ketoacidosis
This study is ongoing, but not recruiting participants.
First Received: December 26, 2007   Last Updated: January 9, 2008   History of Changes
Sponsored by: Marshall University
Information provided by: Marshall University
ClinicalTrials.gov Identifier: NCT00589680
  Purpose

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.


Condition
Diabetic Ketoacidosis

MedlinePlus related topics: Diabetes
U.S. FDA Resources
Study Type: Observational
Study Design: Retrospective
Official Title: Compliance With American Diabetes Association Treatment Guidelines for Adult Ketoacidosis

Further study details as provided by Marshall University:

Primary Outcome Measures:
  • Hospital length of stay [ Time Frame: Time in hospital ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ICU length of stay [ Time Frame: hospital stay ] [ Designated as safety issue: No ]
  • ICU length of stay Hypoglycemic events (BG<60) [ Time Frame: hospital stay ] [ Designated as safety issue: No ]
  • Time to correction of glucose level and anion gap [ Time Frame: hospital stay ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 60
Study Start Date: December 2007
Estimated Study Completion Date: July 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • < 18 years of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00589680

Locations
United States, West Virginia
St. Mary's Medical Center
Huntington, West Virginia, United States, 25702
Sponsors and Collaborators
Marshall University
Investigators
Principal Investigator: Sharon Jones, Pharm.D. St. Mary's Medical Center
  More Information

No publications provided

Responsible Party: St. Mary's Medical Center ( Sharon E. Jones, Pharmacy Clinical Coordinator/Residency Director )
Study ID Numbers: 9137
Study First Received: December 26, 2007
Last Updated: January 9, 2008
ClinicalTrials.gov Identifier: NCT00589680     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Marshall University:
Acidosis, Diabetic
Diabetic Acidosis
Diabetic Ketosis
Ketoacidosis, Diabetic
Ketosis, Diabetic

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Diabetic Ketoacidosis
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Ketosis
Diabetes Complications
Acidosis

Additional relevant MeSH terms:
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Diabetic Ketoacidosis
Glucose Metabolism Disorders
Diabetes Complications
Acid-Base Imbalance
Acidosis

ClinicalTrials.gov processed this record on May 07, 2009