Causes, Characteristics and Treatment of Hypercalcemia in... | NCT06467877

Studies
Causes, Characteristics and Treatment of Hypercalcemia in the Emergency Room of a German Hospital

NCT06467877

Sponsor

University of Cologne

Status

Active, not recruiting

Last Update Posted

Dec 9, 2024Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Hypercalcemia

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2010Actual

Primary Completion Date

Mar 31, 2021Actual

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Jun 14, 2024

First Submission Date that Met QC Criteria

Jun 20, 2024

First Posted Date

Jun 21, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2024

Last Update Posted Date

Dec 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Retrospective Chart Review		Group includes patient with hypercalcemia ≥2.65 mmol/l, who reported to the emergency room of a tertiary hospital

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Development of total calcium values	Overview of total calcium values within 5 days	5 days after enrollment

Secondary Outcomes

Measure	Description	Time Frame
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	5 days after enrollment
Correlation creatinine calcium

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years
Total calcium ≥ 2.65 mmol/l
Female and male

Exclusion Criteria:

Age < 18 years
Total calcium < 2.65 mmol/

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients reporting to the Emergency Room of the University Hospital Cologne and recieved a determination of the total calcium level

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Volker Burst, MD	University Hospital of Cologne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department II of Internal Medicine,University of Cologne		Cologne		50937	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006934	Hypercalcemia
D004630	Emergencies

Ancestor Terms

ID	Term
D002128	Calcium Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D014883	Water-Electrolyte Imbalance

Browse Leaves

Not provided

Browse Branches

Not provided