Effect of a Higher Blood-pressure on Right Ventricular Function
Primary Purpose
Blood Pressure, Right Ventricular Dysfunction
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Norepinephrine
Sponsored by
About this trial
This is an interventional diagnostic trial for Blood Pressure
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.
Sites / Locations
- Medical Center Leeuwarden
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
intervention
control
Arm Description
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
control group; treatment according to current standards, observation of the effect on right ventricular function
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Echocardiographic
Echocardiographic parameters of RV and LV contractility
RV end-diastolic pressure
RV end-diastolic pressure pre and post intervention
Cardiac index
Difference in cardiac index between intervention and control groups
Fluid balance
Difference in fluid balance between intervention and control groups
Full Information
NCT ID
NCT03806582
First Posted
October 29, 2018
Last Updated
May 25, 2020
Sponsor
Medical Centre Leeuwarden
1. Study Identification
Unique Protocol Identification Number
NCT03806582
Brief Title
Effect of a Higher Blood-pressure on Right Ventricular Function
Official Title
Effect of a Higher Blood-pressure on Right Ventricular Function
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
May 15, 2020 (Actual)
Study Completion Date
May 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Centre Leeuwarden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Right Ventricular Dysfunction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
open label study
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Active Comparator
Arm Description
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
Arm Title
control
Arm Type
No Intervention
Arm Description
control group; treatment according to current standards, observation of the effect on right ventricular function
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Description
intervention with norepinephrine to reach a MAP of 85 mmHg
Primary Outcome Measure Information:
Title
right ventricular ejection fraction
Description
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.
Time Frame
2 hours postoperative
Secondary Outcome Measure Information:
Title
Echocardiographic
Description
Echocardiographic parameters of RV and LV contractility
Time Frame
2 hours postoperative
Title
RV end-diastolic pressure
Description
RV end-diastolic pressure pre and post intervention
Time Frame
baseline and 15 minutes postoperatively
Title
Cardiac index
Description
Difference in cardiac index between intervention and control groups
Time Frame
2 hours postoperative
Title
Fluid balance
Description
Difference in fluid balance between intervention and control groups
Time Frame
2 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christiaan Boerma, Dr
Organizational Affiliation
Medical Centre Leeuwarden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Center Leeuwarden
City
Leeuwarden
ZIP/Postal Code
8904 BR
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of a Higher Blood-pressure on Right Ventricular Function
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