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In this pilot study, the investigators will determine the response of the natriuretic peptide (NP) hormone system after a dose of intravenous dexamethasone (a steroid medication). The goal of the proposed project is to generate preliminary data that will be used to develop power calculations, inform cutoff ranges, and inform the timing of the NP response for larger subsequent studies.
Aim: To determine the range of distribution and time course of natriuretic peptide (NP) responses to a single dose of dexamethasone IV 4 mg in healthy lean individuals.
Hypothesis: Determination of the NP responses (the range and time course of changes in NP levels) to dexamethasone in 10 healthy individuals will inform the time course and frequency of blood sampling in a definitive prospective study, as well as enable investigators to perform a sample size calculation for a definitive prospective study.
see above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy | Experimental | 10 Healthy subjects will undergo study procedures at four study visits. All subjects will undergo the same procedures and interventions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | A single dose of dexamethasone IV 4 mg will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in NT-proANP From Baseline to 8 Hours | Change in natriuretic peptide levels after drug administration | baseline and 8 hours |
| Changes in NT-proBNP From Baseline to 8 Hours | Change in natriuretic peptide levels after drug administration | Baseline and 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in NT-proANP | Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours | baseline, 24 hours, 48 hours and 72 hours |
| Changes in NT-proBNP |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine N Bachmann, MD | Vanderbilt Endocrinology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | United States |
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1 participant withdrew after consent but before the baseline visit and is not included in the results.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy | Healthy subjects will be enrolled and each will undergo study procedures at four study visits. All subjects will undergo the same procedures and interventions. Dexamethasone: A single dose of dexamethasone IV 4 mg will be administered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy | Healthy subjects will be enrolled and each will undergo study procedures at 4 study visits. All subjects will undergo the same procedures and interventions. Dexamethasone: A single dose of dexamethasone IV 4 mg will be administered. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in NT-proANP From Baseline to 8 Hours | Change in natriuretic peptide levels after drug administration | Posted | Mean | Standard Deviation | nmol/l | baseline and 8 hours |
|
|
48 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy | Healthy subjects will be enrolled and each will undergo study procedures at three study visits. All subjects will undergo the same procedures and interventions. Dexamethasone: A single dose of dexamethasone IV 4 mg will be administered. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grace Henderson, Study Coordinator | Vanderbilt University Medical Center | 615-936-5356 | grace.henderson@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 18, 2017 | Aug 16, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours
| at baseline, 24 hours, 48 hours and 72 hours |
| BNP (B-type Natriuretic Peptide) | Natriuretic peptide levels after drug administration | 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration |
| ANP (Atrial Natriuretic Peptide) | Natriuretic peptide levels after drug administration | 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Primary | Changes in NT-proBNP From Baseline to 8 Hours | Change in natriuretic peptide levels after drug administration | Posted | Mean | Standard Deviation | pg/ml | Baseline and 8 hours |
|
|
|
| Secondary | Changes in NT-proANP | Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours | Posted | Mean | Standard Deviation | nmol/l | baseline, 24 hours, 48 hours and 72 hours |
|
|
|
| Secondary | Changes in NT-proBNP | Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours | Posted | Mean | Standard Deviation | pg/ml | at baseline, 24 hours, 48 hours and 72 hours |
|
|
|
| Secondary | BNP (B-type Natriuretic Peptide) | Natriuretic peptide levels after drug administration | Analysis was not able to be completed on any of the samples because reliable assay is not available at this time. | Posted | 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration |
|
|
| Secondary | ANP (Atrial Natriuretic Peptide) | Natriuretic peptide levels after drug administration | Analysis was not able to be completed on any of the samples because reliable assay is not available at this time. | Posted | 0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|