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NCT Number: NCT03806582

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical Center Leeuwarden

Leeuwarden, 8904 BR, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

norepinephrine

Drug

intervention with norepinephrine to reach a MAP of 85 mmHg

Primary outcomes

  1. right ventricular ejection fraction

    Time frame: 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 outcomes

  1. Echocardiographic

    Time frame: 2 hours postoperative

    Echocardiographic parameters of RV and LV contractility

  2. RV end-diastolic pressure

    Time frame: baseline and 15 minutes postoperatively

    RV end-diastolic pressure pre and post intervention

  3. Cardiac index

    Time frame: 2 hours postoperative

    Difference in cardiac index between intervention and control groups

  4. Fluid balance

    Time frame: 2 hours postoperative

    Difference in fluid balance between intervention and control groups

Sponsors and collaborators

Lead sponsor

Frisius Medisch Centrum

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 16, 2019
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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