Blood Pressure Clinical Trial
Official title:
Effect of a Higher Blood-pressure on Right Ventricular Function
NCT number | NCT03806582 |
Other study ID # | TPO 1051 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | March 1, 2019 |
Est. completion date | May 25, 2020 |
Verified date | May 2020 |
Source | Medical Centre Leeuwarden |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Right ventricular (RV) dysfunction in cardiac surgery is an independent risk factor for morbidity and mortality. Raising the systemic blood pressure with norepinephrine seems to have a positive influence on the right ventricular function in several animal studies. The current study is designed to evaluate the effect of a higher blood pressure on the RV function in post cardiac surgery patients.
Status | Completed |
Enrollment | 78 |
Est. completion date | May 25, 2020 |
Est. primary completion date | May 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - post operative cardiac surgery patients, full sternotomy - admission at ICU - informed consent - right ventricular monitoring by pulmonary artery catheter. - RVEF <30% + MAP = 65mmHg Exclusion Criteria: - no informed consent - acute surgery - Off pump cardiac surgery - Severe tricuspid insufficiency - Allergy to norepinephrine - Severe left ventricular hypertrophy with systolic anterior movement - Chronic use of alpha-blockers - Irregulair heart rhythm - Surgical reasons to maintain a low blood pressure. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Medical Center Leeuwarden | Leeuwarden |
Lead Sponsor | Collaborator |
---|---|
Medical Centre Leeuwarden |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | right ventricular ejection fraction | Primary endpoint is the difference between the intervention and the control group in the change over time between baseline and the end of the study period (T4) in RVEF. | 2 hours postoperative | |
Secondary | Echocardiographic | Echocardiographic parameters of RV and LV contractility | 2 hours postoperative | |
Secondary | RV end-diastolic pressure | RV end-diastolic pressure pre and post intervention | baseline and 15 minutes postoperatively | |
Secondary | Cardiac index | Difference in cardiac index between intervention and control groups | 2 hours postoperative | |
Secondary | Fluid balance | Difference in fluid balance between intervention and control groups | 2 hours postoperative |
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