Effect of a Higher Blood-pressure on Right Ventricular Function

NCT03806582 | Completed Phase 4

• 1 other identifier: TPO 1051
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Right Ventricular Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Echocardiographic

  2 hours postoperative

• RV end-diastolic pressure

  baseline and 15 minutes postoperatively

• Cardiac index

  2 hours postoperative

• Fluid balance

  2 hours postoperative

Study Arms (2)

intervention

ACTIVE COMPARATOR

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

control

NO INTERVENTION

control group; treatment according to current standards, observation of the effect on right ventricular function

Interventions

Norepinephrine DRUG

intervention with norepinephrine to reach a MAP of 85 mmHg

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• post operative cardiac surgery patients, full sternotomy
• admission at ICU
• informed consent
• right ventricular monitoring by pulmonary artery catheter.
• RVEF \<30% + MAP ≤ 65mmHg

You may not qualify if:

• 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.

Sponsors & Collaborators

• Frisius Medisch Centrum: lead

Study Sites (1)

Medical Center Leeuwarden

Leeuwarden, 8904 BR, Netherlands

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Right

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Christiaan Boerma, Dr

  Frisius Medisch Centrum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open label study
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: January 16, 2019
• Study Start: March 1, 2019
• Primary Completion: May 15, 2020
• Study Completion: May 25, 2020
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)