HypercalcemiaNCT06467877
Causes, Characteristics and Treatment of Hypercalcemia in the Emergency Room of a German Hospital
An observational study of Hypercalcemia, run by University of Cologne at 1 site in Germany.
Trial summary
Patients with hypercalcemia were identified in the patient population of a German emergency department during a 11 year time period and studied regarding reproducibility of elevated calcium values, causes of hypercalcemia, symptoms. acute renal injury, mortality and treatment response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercalcemia
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2010to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients reporting to the Emergency Room of the University Hospital Cologne and recieved a determination of the total calcium level
Who may be able to join
- Age > 18 years
- Total calcium ≥ 2.65 mmol/l
- Female and male
Who cannot join
- Age < 18 years
- Total calcium < 2.65 mmol/
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department II of Internal Medicine,University of Cologne
Cologne, 50937
About this study
Official title: Retrospective Analysis of Causes, Clinical Presentation and Treatment in Patients With Hypercalcaemia in the Emergency Department of a Tertiary German Hospital
Patients with hypercalcemia were identified in the patient population of a German emergency department during a 11 year time period and studied regarding reproducibility of elevated calcium values, causes of hypercalcemia, symptoms. acute renal injury, mortality and treatment response.
Read the detailed description
Patients, who presented to the emergency department of a tertiary German hospital with a total calcium of ≥2.65 mmol/l between January 2010 and March 2021, was retrospectively studied. From the electronic patient records we analyzed if the elevated calcium values were reproducible in follow-up measurements, identified the cause of hypercalcemia, listed the symptoms, investigated a correlation between calcium and creatinine values to study acute renal injury directly due to hypercalcemia, calculated the mortality rate stratified by the calcium value on presentation and studied the treatment response regarding lowering calcium values by different treatments.
- Conditions
- Hypercalcemia
- Keywords
- hypercalcemia, calcium, emergency room, mortality
- Medical subject headings
- Hypercalcemia, Emergencies
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 |
|---|---|---|
| Retrospective Chart Review | Group includes patient with hypercalcemia ≥2.65 mmol/l, who reported to the emergency room of a tertiary hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of total calcium values
Overview of total calcium values within 5 days
Measured: 5 days after enrollment
Secondary outcomes (3)
Reproducibility of elevated calcium values
Determination of cause of hypercalcemia, of symptoms, of treatment response. In dependence of hospital stay, kann be determined later than 5 days after enrollment
Measured: 5 days after enrollment
Correlation creatinine calcium
Determination of correlation between calcium and creatinine.
Measured: 5 days after enrollment
Mortality
occurence of death within of 5 days after enrollment
Measured: 5 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Jan 2010
- Primary completion31 Mar 2021
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercalcemiaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volker Burst, University of Cologne
- Investigators
- Volker Burst, MD, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467877
- Sponsor's protocol ID
- V1.0-13.05.2024
- Status last verified
- Dec 2024
- First submitted
- 14 Jun 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Causes, Clinical Presentation and Treatment in Patients With Hypercalcaemia in the Emergency Department of a Tertiary German Hospital
- ClinicalTrials.gov ID
- NCT06467877
- Acronym / sponsor ID
- V1.0-13.05.2024
- Conditions
- Hypercalcemia
- Keywords
- hypercalcemia, calcium, emergency room, mortality
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Jun 2024 (actual)
- 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.
Patients with hypercalcemia were identified in the patient population of a German emergency department during a 11 year time period and studied regarding reproducibility of elevated calcium values, causes of hypercalcemia, symptoms. acute renal injury, mortality and treatment response.
Detailed description
Patients, who presented to the emergency department of a tertiary German hospital with a total calcium of ≥2.65 mmol/l between January 2010 and March 2021, was retrospectively studied. From the electronic patient records we analyzed if the elevated calcium values were reproducible in follow-up measurements, identified the cause of hypercalcemia, listed the symptoms, investigated a correlation between calcium and creatinine values to study acute renal injury directly due to hypercalcemia, calculated the mortality rate stratified by the calcium value on presentation and studied the treatment response regarding lowering calcium values by different treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective Chart Review | – | –Group includes patient with hypercalcemia ≥2.65 mmol/l, who reported to the emergency room of a tertiary hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients reporting to the Emergency Room of the University Hospital Cologne and recieved a determination of the total calcium level
Key inclusion criteria (3 listed)
- Age > 18 years
- Total calcium ≥ 2.65 mmol/l
- Female and male
Key exclusion criteria (2 listed)
- Age < 18 years
- Total calcium < 2.65 mmol/
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
Development of total calcium values
Time frame: 5 days after enrollment
Overview of total calcium values within 5 days
3 secondary outcomes
Reproducibility of elevated calcium values
Time frame: 5 days after enrollment
Correlation creatinine calcium
Time frame: 5 days after enrollment
Mortality
Time frame: 5 days after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Volker Burst, MD principal investigator
University Hospital of Cologne
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 Hypercalcemia, run by University of Cologne 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 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: under way, not looking for participants, as of the sponsor's last update on 9 Dec 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Development of total calcium values (time frame: 5 days after enrollment). 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 9 Dec 2024.