Development of Non-invasive Protocol Clinical Trial
Official title:
Non-invasive Fluid Volume During Fluid Shifts Technique Validation
| Verified date | December 2022 |
| Source | Mayo Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is designed to answer the question of if several non-invasive methods are comparable to the invasive clinical gold standard of radiolabeled albumin in terms of detecting changes in fluid volume. It is broken into two studies: Aim 1 Study A is designed as a pilot phase to develop the non-techniques, and Aim 2 Study B is comparing these techniques to the gold standard.
| Status | Completed |
| Enrollment | 14 |
| Est. completion date | October 26, 2022 |
| Est. primary completion date | October 26, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 21 Years and older |
| Eligibility | 1. Non-smokers 2. Have a BMI<30 3. Have no chronic disease 4. Be free of medications with known cardiovascular effects |
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic in Florida | Jacksonville | Florida |
| United States | Mayo Clinic in Rochester | Rochester | Minnesota |
| United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Validation against Gold Standard | The non-invasive methods being investigated will be non-inferior in measuring the blood or fluid volumes in healthy participants when compared to the gold standard. | 2 years |