Hemodilution Clinical Trial
Official title:
The Evaluation of Minimally Invasive Hemodynamic Monitors for the Assessment of Volume Responsiveness to Various Standard Replacement Fluids During Acute Normovolemic Hemodilution
| NCT number | NCT02179827 |
| Other study ID # | 362559 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 2022 |
| Est. completion date | November 2024 |
| Verified date | April 2022 |
| Source | University of California, Davis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The aim of this study is to assess the responsiveness of the standard minimally invasive hemodynamic monitors used in the operating room to known changes in the intravascular volume status that occur during blood removal and volume replacement with three different standard fluids used during ANH.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | November 2024 |
| Est. primary completion date | November 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | Inclusion Criteria: - Those surgical procedures where ANH is included in the surgical plan and consent is obtained Exclusion Criteria: - Severe or symptomatic COPD, emphysema, renal, hepatic or coronary artery disease as defined by the American College of Cardiology (Cannon et al., 2001). - Esophageal pathology (diverticulum, hiatal hernia, esophageal cancer, esophageal surgery), which introduces risks associated with the placement of the esophageal Doppler. - Ascites. - BMI >35 - Pregnancy |
| Country | Name | City | State |
|---|---|---|---|
| United States | UC Davis Health System | Sacramento | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, Davis |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in cardiac output | Metrics: Cardiac output stroke volume Stroke volume: variation | Baseline (Supine) Volume Replaced (S/P ANH) |
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|---|---|---|---|
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