Effect of a Higher Blood-pressure on Right Ventricular Function

• Sponsor: Medical Centre Leeuwarden (Other)
• Overall Status: Completed
• CT.gov ID: NCT03806582
• Collaborator: (none)
• Enrollment: 78
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.8
• Patients Per Site Per Month: 5.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure; Right Ventricular Dysfunction	Drug: Norepinephrine	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: open label study
• Primary Purpose: Diagnostic
• Official Title: Effect of a Higher Blood-pressure on Right Ventricular Function
• Actual Study Start Date: Mar 1, 2019
• Actual Primary Completion Date: May 15, 2020
• Actual Study Completion Date: May 25, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Echocardiographic [2 hours postoperative]

   Echocardiographic parameters of RV and LV contractility

2. RV end-diastolic pressure [baseline and 15 minutes postoperatively]

   RV end-diastolic pressure pre and post intervention

3. Cardiac index [2 hours postoperative]

   Difference in cardiac index between intervention and control groups

4. Fluid balance [2 hours postoperative]

   Difference in fluid balance between intervention and control groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Center Leeuwarden	Leeuwarden		Netherlands	8904 BR

Sponsors and Collaborators

• Medical Centre Leeuwarden

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: E.C. Boerma, Dr, Medical Centre Leeuwarden
• ClinicalTrials.gov Identifier: NCT03806582
• Other Study ID Numbers: TPO 1051
• First Posted: Jan 16, 2019
• Last Update Posted: May 27, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ventricular Dysfunction; Ventricular Dysfunction, Right; Norepinephrine

Study Results

No Results Posted as of May 27, 2020