Effect of a Higher Blood-pressure on Right Ventricular Function

Phase 4

Completed

• Conditions: Right Ventricular Dysfunction; Blood Pressure
• Interventions: Drug: Norepinephrine

• Registration Number: NCT03806582
• Lead Sponsor: Medical Centre Leeuwarden

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.

Study Timeline

• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-16
• Study Start: 2019-03-01
• Status Verified: 2020-05
• Primary Completion: 2020-05-15
• Study Completion: 2020-05-25
• Last Update Submitted: 2020-05-25
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	Norepinephrine	intervention with norepinephrine to reach a MAP of 85 mmHg for a maximum duration of 1 hour, observation of the effect on right ventricular function

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical Center Leeuwarden; 🇳🇱 Leeuwarden, Netherlands