Blood Pressure, Right Ventricular Dysfunction
Conditions
Brief summary
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.
Detailed description
Goal: To demonstrate differences in RV function by raising the systemic blood pressure with norepinephrine. Study design: randomized controlled trial Study population: 78 postoperative cardiac surgery patients admitted at the ICU. Intervention: * Group 1: (N=22): RVEF\<20% and MAP≤65mmHg. Intervention with norepinephrine to reach a MAP of 85mmHg for a maximum duration of two hours. * Group 2: (N=22): RVEF \<20% and MAP≤65mmHg. Control group: treatment according to current standards. Hypotensive patients are treated with fluids and/or vasopressors to gain a mean arterial pressure (MAP) of 65mmHg. * Group 3: (N=17): RVEF between ≥20 and \<30% and MAP ≤65mmHg. Intervention with norepinephrine to reach a MAP of 85mmHg for a maximum duration of two hours. * Group 4: (N=17): RVEF between ≥20 and \<30% and MAP ≤65mmHg. Control group: treatment according to current standards. Hypotensive patients are treated with fluids and/or vasopressors to gain a mean arterial pressure (MAP) of 65mmHg. Endpoints: 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. Secondary endpoints are the echocardiographic parameters of RV and LV contractility, RV end-diastolic pressure, cardiac index, and fluid balance.
Interventions
DRUGNorepinephrine
intervention with norepinephrine to reach a MAP of 85 mmHg
Sponsors
Frisius Medisch Centrum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
open label study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| right ventricular ejection fraction | 2 hours postoperative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Echocardiographic | 2 hours postoperative | Echocardiographic parameters of RV and LV contractility |
| RV end-diastolic pressure | baseline and 15 minutes postoperatively | RV end-diastolic pressure pre and post intervention |
| Cardiac index | 2 hours postoperative | Difference in cardiac index between intervention and control groups |
| Fluid balance | 2 hours postoperative | Difference in fluid balance between intervention and control groups |
Countries
Netherlands
Outcome results
None listed