Effect of a Higher Blood-pressure on Right Ventricular Fu... | NCT03806582

Studies
Effect of a Higher Blood-pressure on Right Ventricular Function

NCT03806582

Sponsor

Frisius Medisch Centrum

Status

Completed

Last Update Posted

May 27, 2020Actual

Enrollment

78Actual

Phase

Phase 4

Conditions

Blood Pressure
Right Ventricular Dysfunction

Interventions

Norepinephrine

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2019Actual

Primary Completion Date

May 15, 2020Actual

Completion Date

May 25, 2020Actual

First Submitted Date

Oct 29, 2018

First Submission Date that Met QC Criteria

Jan 15, 2019

First Posted Date

Jan 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2020

Last Update Posted Date

May 27, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

E.C. Boerma, Dr, Frisius Medisch CentrumPrincipal Investigator

Lead Sponsor

Frisius Medisch CentrumOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Norepinephrine	Drug	intervention with norepinephrine to reach a MAP of 85 mmHg	intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Echocardiographic	Echocardiographic parameters of RV and LV contractility	2 hours postoperative
RV end-diastolic pressure	RV end-diastolic pressure pre and post intervention

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christiaan Boerma, Dr	Frisius Medisch Centrum	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Center Leeuwarden		Leeuwarden		8904 BR	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018497	Ventricular Dysfunction, Right

Ancestor Terms

ID	Term
D018754	Ventricular Dysfunction
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009638	Norepinephrine

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided