Effect of a Higher Blood-pressure on Right Ventricular Function

NCT ID: NCT03806582

Last Updated: 2020-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2020-05-25

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.

Conditions

Blood Pressure; Right Ventricular Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

intervention

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

Group Type: ACTIVE_COMPARATOR

Norepinephrine

Intervention Type: DRUG

intervention with norepinephrine to reach a MAP of 85 mmHg

control

control group; treatment according to current standards, observation of the effect on right ventricular function

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Norepinephrine

intervention with norepinephrine to reach a MAP of 85 mmHg

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Frisius Medisch Centrum

OTHER

Sponsor Role: lead

Responsible Party

E.C. Boerma

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christiaan Boerma, Dr

Role: PRINCIPAL_INVESTIGATOR

Frisius Medisch Centrum

Locations

Medical Center Leeuwarden

Leeuwarden, , Netherlands

Countries

Netherlands

Other Identifiers

TPO 1051

Identifier Type: -

Identifier Source: org_study_id