Effect of a Higher Blood-pressure on Right Ventricular Function

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Right Ventricular Dysfunction
• Intervention / Treatment: Drug: Norepinephrine

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 Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Leeuwarden, Netherlands, 8904 BR
    • Medical Center Leeuwarden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Norepinephrine; intervention with norepinephrine to reach a MAP of 85 mmHg
No Intervention: control; control group; treatment according to current standards, observation of the effect on right ventricular function

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiographic	Echocardiographic parameters of RV and LV contractility	2 hours postoperative
RV end-diastolic pressure	RV end-diastolic pressure pre and post intervention	baseline and 15 minutes postoperatively
Cardiac index	Difference in cardiac index between intervention and control groups	2 hours postoperative
Fluid balance	Difference in fluid balance between intervention and control groups	2 hours postoperative

Collaborators and Investigators

• Sponsor: Medical Centre Leeuwarden
• Investigators: Principal Investigator: Christiaan Boerma, Dr, Medical Centre Leeuwarden

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): May 15, 2020
• Study Completion (Actual): May 25, 2020

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: January 15, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 25, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Right; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympathomimetics; Vasoconstrictor Agents; Norepinephrine
• Other Study ID Numbers: TPO 1051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No