NCT02640846

Brief Summary

The aim of this study is to investigate the effects milrinon and levosimandan on n heart function in septic cardiomyopathy and how norepinephrine affects the left and right ventricular function in patients with septick shock using pulmonary artery catheter, conventional and strain echocardiography.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

November 29, 2018

Status Verified

December 1, 2015

Enrollment Period

3.1 years

First QC Date

December 6, 2015

Last Update Submit

November 27, 2018

Conditions

Septic ShockCardiomyopathy

Keywords

LevosimendanMilrinoneMyocardial strainSeptic cardiomyopathyNorepinephrine

Outcome Measures

Primary Outcomes (2)

  • Changes in LV systolic strain

    Changes in LV systolic function (global strain) will be assessed by 2D speckle tracking echocardiography

    1.5 hours

  • Changes in RV systolic strain

    Changes in RV systolic function (RV free wall strain) will be assessed by 2D speckle tracking echocardiography

    1.5 hours

Study Arms (3)

Norepinephrine

ACTIVE COMPARATOR

Doser

Drug: Norepinephrine

Milrinone

ACTIVE COMPARATOR

Doser

Drug: Milrinone

Levosimendan

ACTIVE COMPARATOR

Doser

Drug: Levosimendan

Interventions

NorepinephrineDRUG

Norepinephrine will be given to the patient due to septic shock. After the inclusion we will change the dose of Norepinephrine to achieve 3 different MAP-levels, 60 mmHg, 75 mmHg and 90 mmHg.

Norepinephrine
MilrinoneDRUG

Corotrope will be given and after 30 minutes of treatment the cardiac function will be assessed with echocardiography and systemic hemodynamics.

Also known as: Corotrope
Milrinone
LevosimendanDRUG

Levosimendan will be given and after 30 minutes of treatment the cardiac function will be assessed with echocardiography and systemic hemodynamics.

Also known as: Simdax
Levosimendan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Septic shock.
  • Need of Norepinephrine infusion.
  • Myocardial dysfunction in echocardiogram, either LVEF \< 50% or Global Left Ventricular Systolic strain over -15%.

You may not qualify if:

  • History of previous heart disease or pulmonary hypertension.
  • Age \< 18 years.
  • Cardiac arrhythmia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central intensivvårdsavdelning Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 41345, Sweden

Location

MeSH Terms

Conditions

Shock, SepticCardiomyopathies

Interventions

NorepinephrineMilrinoneSimendan

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsAmrinoneAminopyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHydrazonesHydrazinesPyridazines

Study Officials

  • Sven-Erik Ricksten, Professor

    Sahlgrenska Academy, dep of clinical science

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 6, 2015

First Posted

December 29, 2015

Study Start

December 1, 2015

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

November 29, 2018

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)