Stress HyperglycemiaNCT02946411
Correlation of Hospital Stay Length With the Glucose Levels After Cardiac Surgery
An observational study of Stress Hyperglycemia, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
The study is designed to test if there is any correlation between the glucose levels in the postoperatory period and the length of hospital stay. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Stress Hyperglycemia
- What is being tested?
- Cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteMexico
- Study dates
- 1 Nov 2016to Dec 2021
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with a programmed cardiac surgery
Who may be able to join
- Physical status classification of the American Society of Anesthesiologists (ASA) II-IV
- Patients programmed for cardiac surgery
- Any body mass index
Who cannot join
- Pregnant women
- Chronic Kidney Disease (CKD) Stage 2 or higher
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of Hospital Stay Length With the Glucose Measured Continuously Levels After Cardiac Surgery
The study is designed to test if there is any correlation between the glucose levels in the postoperatory period and the length of hospital stay.
Read the detailed description
The stress hyperglycemia commonly observed in the postoperatory period, there have been several studies to assess if there is benefit of having a strict glucose control or not.
This study will assess if there is correlation between the glucose levels measured continuously with the length of the stay in the hospital.
- Conditions
- Stress Hyperglycemia
- Being tested
- Cardiac surgery
- Keywords
- Hyperglycemia
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgeryProcedure or surgery
Glucose level will be measured after cardiac surgery.
| Study group | Role | What they receive |
|---|---|---|
| Patients | The glucose of 48 patients will be measured during 5 days after cardiac surgery. Receives: Procedure: Cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose
Glucose will be continuously monitored for 5 days
Measured: 5 days
Secondary outcomes (1)
Hospital stay
The days that the patient remains in the hospital after the surgery.
Measured: [Days] Within the first 20 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study start1 Nov 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress HyperglycemiaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ana Gallardo, Dr., Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946411
- Sponsor's protocol ID
- R-2016-785.080
- Status last verified
- Aug 2020
- First submitted
- 20 Oct 2016
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Hospital Stay Length With the Glucose Measured Continuously Levels After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02946411
- Acronym / sponsor ID
- R-2016-785.080
- Conditions
- Stress Hyperglycemia
- Keywords
- Hyperglycemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 27 Oct 2016 (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.
The study is designed to test if there is any correlation between the glucose levels in the postoperatory period and the length of hospital stay.
Detailed description
The stress hyperglycemia commonly observed in the postoperatory period, there have been several studies to assess if there is benefit of having a strict glucose control or not.
This study will assess if there is correlation between the glucose levels measured continuously with the length of the stay in the hospital.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: Cardiac surgeryThe glucose of 48 patients will be measured during 5 days after cardiac surgery. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with a programmed cardiac surgery
Key inclusion criteria (3 listed)
- Physical status classification of the American Society of Anesthesiologists (ASA) II-IV
- Patients programmed for cardiac surgery
- Any body mass index
Key exclusion criteria (2 listed)
- Pregnant women
- Chronic Kidney Disease (CKD) Stage 2 or higher
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac surgeryGlucose level will be measured after cardiac surgery. | Procedure or surgery | Patients |
Primary outcome
Glucose
Time frame: 5 days
Glucose will be continuously monitored for 5 days
1 secondary outcome
Hospital stay
Time frame: [Days] Within the first 20 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Ana Gallardo, Dr. principal investigator
Investigator
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 Stress Hyperglycemia, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Aug 2020. 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 Mexico. 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?
Results are not available in the source record.
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?
Glucose (time frame: 5 days). 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 6 Aug 2020.