Diabetic KetoacidosisNCT00589680
Compliance With American Diabetes Association Treatment Guidelines for Adult Ketoacidosis
An observational study of Diabetic Ketoacidosis, run by Marshall University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diabetic Ketoacidosis
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those patients admitted to St. Mary's Medical Center with a diagnosis of DKA.
Who may be able to join
- Admitted to St. Mary's Medical Center with DKA
- >/= 18 years of age
Who cannot join
- < 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Mary's Medical Center
Huntington, West Virginia, 25702
About this study
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.
- Conditions
- Diabetic Ketoacidosis
- Keywords
- Acidosis, Diabetic, Diabetic Acidosis, Diabetic Ketosis, Ketoacidosis, Diabetic, Ketosis, Diabetic
- Medical subject headings
- Diabetic Ketoacidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
Measured: Time in hospital
Secondary outcomes (3)
ICU length of stay
Measured: hospital stay
ICU length of stay Hypoglycemic events (BG<60)
Measured: hospital stay
Time to correction of glucose level and anion gap
Measured: hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marshall University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Jones, Marshall University
- Investigators
- Sharon Jones, Pharm.D., Principal investigator, St. Mary's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589680
- Sponsor's protocol ID
- 9137
- Status last verified
- Mar 2024
- First submitted
- 26 Dec 2007
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance With American Diabetes Association Treatment Guidelines for Adult Ketoacidosis
- ClinicalTrials.gov ID
- NCT00589680
- Acronym / sponsor ID
- 9137
- Conditions
- Diabetic Ketoacidosis
- Keywords
- Acidosis, Diabetic, Diabetic Acidosis, Diabetic Ketosis, Ketoacidosis, Diabetic, Ketosis, Diabetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Marshall UniversityUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 10 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those patients admitted to St. Mary's Medical Center with a diagnosis of DKA.
Key inclusion criteria (2 listed)
- Admitted to St. Mary's Medical Center with DKA
- >/= 18 years of age
Key exclusion criteria (1 listed)
- < 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospital length of stay
Time frame: Time in hospital
3 secondary outcomes
ICU length of stay
Time frame: hospital stay
ICU length of stay Hypoglycemic events (BG<60)
Time frame: hospital stay
Time to correction of glucose level and anion gap
Time frame: hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Jones, Pharm.D. principal investigator
St. Mary's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Ketoacidosis, run by Marshall University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital length of stay (time frame: Time in hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.