NCT03806582

Effect of a Higher Blood-pressure on Right Ventricular Function

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Frisius Medisch Centrum · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Blood Pressure
• Right Ventricular Dysfunction

Interventions

Type	Name	Description
DRUG	Norepinephrine	intervention with norepinephrine to reach a MAP of 85 mmHg

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-05-15
• Completion: 2020-05-25
• First posted: 2019-01-16
• Last updated: 2020-05-27

Locations

1 site across 1 country: Netherlands