MalnutritionNCT00741546
Association of Low Vitamin D Levels With Mortality in Patients With Reduced Left Ventricular Function Referred to Cardiac Surgery
An observational study of Malnutrition, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
This study investigates if reduced serum levels of vitamin D concentration are a typical feature in patient group with low left ventricular function admitted for cardiac surgery interventions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malnutrition
- What is being tested?
- Cardiac Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2007to Sep 2010
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted for cardiac surgery intervention
Who may be able to join
- All routinely cardiac procedures
Who cannot join
- dialysis, cancer
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Thoracic and Cardiovascular Surgery
Frankfurt am Main, Hesse, 60590
About this study
This study investigates if reduced serum levels of vitamin D concentration are a typical feature in patient group with low left ventricular function admitted for cardiac surgery interventions. and also the necessity of more preventive strategies for adequate nutrition of these patients with more focus on intake of vitamin D before admission to cardiac surgery.
- Conditions
- Malnutrition
- Being tested
- Cardiac Surgery
- Keywords
- Vitamin D, malnutrition, cardiac surgery, study, emphasize, importance, significant, high risk patient
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac SurgeryProcedure or surgery
Cardiac Surgery
| Study group | Role | What they receive |
|---|---|---|
| A | Patients referred for cardiac surgery intervention Receives: Procedure: Cardiac Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative mortality
Measured: 90day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startMar 2007
- Primary completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741546
- Sponsor's protocol ID
- Vitamin D in cardiac surgery
- Status last verified
- Aug 2008
- First submitted
- 25 Aug 2008
- Last updated
- 26 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Low Vitamin D Levels With Mortality in Patients With Reduced Left Ventricular Function Referred to Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00741546
- Acronym / sponsor ID
- Vitamin D in cardiac surgery
- Conditions
- Malnutrition
- Keywords
- Vitamin D, malnutrition, cardiac surgery, study, emphasize, importance, significant, high risk patient
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Sep 2010 (estimated)
- First posted
- 26 Aug 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.
This study investigates if reduced serum levels of vitamin D concentration are a typical feature in patient group with low left ventricular function admitted for cardiac surgery interventions. and also the necessity of more preventive strategies for adequate nutrition of these patients with more focus on intake of vitamin D before admission to cardiac surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Procedure: Cardiac SurgeryPatients referred for cardiac surgery intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted for cardiac surgery intervention
Key inclusion criteria (1 listed)
- All routinely cardiac procedures
Key exclusion criteria (1 listed)
- dialysis, cancer
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 SurgeryCardiac Surgery | Procedure or surgery | A |
Primary outcome
Perioperative mortality
Time frame: 90day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Malnutrition, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 1 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: status not confirmed, as of the sponsor's last update on 26 Aug 2008. 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 Germany. 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?
Perioperative mortality (time frame: 90day). 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 26 Aug 2008.