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NCT01971944 · ClinicalTrials.gov registry record
The Influence of Beta Blocker Therapy on the Hemodynamic Response to Inotrope Infusion in Patients With Acute Decompensated Heart Failure
A clinical trial, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 50
- Enrollment target
NCT01971944: Completed study, sponsored by University of North Carolina, Chapel Hill.
NCT01971944 is a clinical trial that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01971944 has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study Summary
Purpose: To compare the hemodynamic effects of dobutamine and milrinone in hospitalized patients who are receiving Beta Blocker Participants: Patients who are admitted to the General Cardiology and Heart Failure Services at the University of North Carolina Hospitals with acute decompensated heart failure, who have maintained steady state concentrations of beta blocker therapy (carvedilol or metoprolol), and who are deemed by the health care team to require pulmonary artery catheter placement and inotropic therapy with dobutamine or milrinone by continuous infusion. Patients that are not currently receiving beta blocker therapy will be enrolled for comparative purposes; however, any patient not at steady state (on or off beta blocker therapy) will not be enrolled. Procedures: After obtaining informed consent, patients will be assigned to the appropriate sub-study group based on beta blocker use (Study A: patients on stable doses of metoprolol and Study B: patients on stable doses of carvedilol). All patients should receive dobutamine followed by milrinone as outlined in the dosing algorithm (see inotrope dosing algorithm attached, as part of the usual standard of practice). Baseline pulmonary artery catheter hemodynamic parameters will be collected prior to administration of inotrope trial of dobutamine followed by milrinone. Hemodynamic parameters will be recorded per the dosing algorithm following initiation and dose titration. Dose titration will be determined by the health care team based upon patient response or lack thereof and tolerability. Changes in hemodynamic parameters in response to dobutamine or milrinone will be compared within study groups. Additionally, data will continue to be collected on patients receiving not beta blocker therapy for comparative purpose.
Primary Outcome
Dobutamine will be titrated every 2 hours as tolerated for a total of 3 titrations. Data will be collected over the 6 hour infusion. Milrinone titration timeframes are dependent on renal function and as tolerated by patients. A total of 3 titrations may occur as tolerated over incremental timeframes of 4, 12, 18 and 24 hours. Data will be collected over the 12-72 hours the patient will be receiving the milrinone infusion.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2010-12 |
| Est. Completion | 2018-10 |
What the finished NCT01971944 record still lists
NCT01971944 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01971944 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01971944 about?
NCT01971944 is a clinical study titled "The Influence of Beta Blocker Therapy on the Hemodynamic Response to Inotrope Infusion in Patients With Acute Decompensated Heart Failure". Purpose: To compare the hemodynamic effects of dobutamine and milrinone in hospitalized patients who are receiving Beta Blocker Participants: Patients who are admitted to the General Cardiology and Heart Failure Services at the University of North Carolina Hospitals with acute decompensated heart fa...
What is the current status of trial NCT01971944?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2010-12. Estimated completion is 2018-10.
Who is sponsoring clinical trial NCT01971944?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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