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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03806582
Other study ID # TPO 1051
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
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