Effect of a Higher Blood-pressure on Right Ventricular Function

Blood Pressure Clinical Trial

Official title:

Effect of a Higher Blood-pressure on Right Ventricular Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03806582
• Other study ID #: TPO 1051
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2019
• Est. completion date: May 25, 2020

Study information

• Verified date: May 2020
• Source: Medical Centre Leeuwarden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Blood Pressure
• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

Drug:
• Norepinephrine
intervention with norepinephrine to reach a MAP of 85 mmHg

Locations

Country	Name	City	State
Netherlands	Medical Center Leeuwarden	Leeuwarden

Sponsors (1)

Lead Sponsor	Collaborator
Medical Centre Leeuwarden

Country where clinical trial is conducted

Netherlands, 

Outcome

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