NCT04917497

Brief Summary

To determine whether Levosimendan infusion in patients with cardiogenic shock and cardiorenal syndrome refractory to standard inotropic therapy, improves hemodynamics and renal function, whilst being safe.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2011

Typical duration for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2014

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

2.8 years

First QC Date

May 31, 2021

Last Update Submit

June 7, 2021

Conditions

Cardiogenic ShockCardiorenal SyndromeAcute Kidney Failure

Keywords

LevosimendanInotropic Agent

Outcome Measures

Primary Outcomes (6)

  • Change in Cardiac Index

    Temporal development of Cardiac Index post Levosimendan Infusion up until 120 hours

    Mixed Model Assessment at 0, 1, 2, 4, 6, 12, 24, 48, 72, 96 and 120 hours post Levosimendan Infusion

  • Change in Cardiac Preload Pressures

    Temporal development of Wedge Pressure/ Central Venous Pressure post Levosimendan Infusion up until 120 hours

    Mixed Model Assessment at 0, 1, 2, 4, 6, 12, 24, 48, 72, 96 and 120 hours post Levosimendan Infusion

  • Change in Mean Arterial Pressure

    Temporal development of Mean Arterial Pressure post Levosimendan Infusion up until 120 hours

    Mixed Model Assessment at 0, 1, 2, 4, 6, 12, 24, 48, 72, 96 and 120 hours post Levosimendan Infusion

  • Change in Vasoactive/ Inotropic Dosage

    Temporal development of Norepinephrine/ Dobuatmine Dosage post Levosimendan Infusion up until 120 hours

    Mixed Model Assessment at 0, 1, 2, 4, 6, 12, 24, 48, 72, 96 and 120 hours post Levosimendan Infusion

  • Change in Renal Function

    Temporal development of eGFR (Creatinin estimated) post Levosimendan Infusion up until 120 hours

    Mixed Model Assessment at 0, 1, 2, 4, 6, 12, 24, 48, 72, 96 and 120 hours post Levosimendan Infusion

  • Change in Fluid Balance

    Temporal development of Fluid Balance post Levosimendan Infusion up until 120 hours

    Mixed Model Assessment at 0, 1, 2, 4, 6, 12, 24, 48, 72, 96 and 120 hours post Levosimendan Infusion

Study Arms (1)

Levosimendan Treated Group

All patients consecutively admitted to the medical ICU of the University Hospital Zurich aged over 18 years, with an underlying cardiogenic shock, receiving Levosimendan.

Drug: Levosimendan

Interventions

LevosimendanDRUG

Levosimendan was administered according to a standardized treatment protocol. A total dose of 12.5mg or 25mg (corresponding to one or two ampoules) was given at an infusion rate of 0.05 μg/kg/min to 0.2μg/kg/min with or without a loading dose (6 μg/kg or 3 μg/kg over 10 minutes). The decision about total dose, infusion rate and loading dose was at the discretion of the treating physician.

Levosimendan Treated Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients consecutively admitted to the medical ICU of the University Hospital Zurich aged over 18 years, with an underlying cardiogenic shock, receiving Levosimendan

You may qualify if:

  • Levosimendan
  • Cardiogenic Shock
  • Continuous monitoring of cardiac output at the start of and during treatment with Levosimendan

You may not qualify if:

  • Extracorporal hemodynamic support or an implanted ventricular assist device
  • Previous therapy with Levosimendan during the index hospitalization
  • Refusal of participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Califf RM, Bengtson JR. Cardiogenic shock. N Engl J Med. 1994 Jun 16;330(24):1724-30. doi: 10.1056/NEJM199406163302406. No abstract available.

    PMID: 8190135BACKGROUND

  • van Diepen S, Katz JN, Albert NM, Henry TD, Jacobs AK, Kapur NK, Kilic A, Menon V, Ohman EM, Sweitzer NK, Thiele H, Washam JB, Cohen MG; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Quality of Care and Outcomes Research; and Mission: Lifeline. Contemporary Management of Cardiogenic Shock: A Scientific Statement From the American Heart Association. Circulation. 2017 Oct 17;136(16):e232-e268. doi: 10.1161/CIR.0000000000000525. Epub 2017 Sep 18.

    PMID: 28923988BACKGROUND

  • Hochman JS. Cardiogenic shock complicating acute myocardial infarction: expanding the paradigm. Circulation. 2003 Jun 24;107(24):2998-3002. doi: 10.1161/01.CIR.0000075927.67673.F2. No abstract available.

    PMID: 12821585BACKGROUND

  • Ronco C, House AA, Haapio M. Cardiorenal syndrome: refining the definition of a complex symbiosis gone wrong. Intensive Care Med. 2008 May;34(5):957-62. doi: 10.1007/s00134-008-1017-8. Epub 2008 Feb 5.

    PMID: 18251008BACKGROUND

  • Papp Z, Edes I, Fruhwald S, De Hert SG, Salmenpera M, Leppikangas H, Mebazaa A, Landoni G, Grossini E, Caimmi P, Morelli A, Guarracino F, Schwinger RH, Meyer S, Algotsson L, Wikstrom BG, Jorgensen K, Filippatos G, Parissis JT, Gonzalez MJ, Parkhomenko A, Yilmaz MB, Kivikko M, Pollesello P, Follath F. Levosimendan: molecular mechanisms and clinical implications: consensus of experts on the mechanisms of action of levosimendan. Int J Cardiol. 2012 Aug 23;159(2):82-7. doi: 10.1016/j.ijcard.2011.07.022. Epub 2011 Jul 23.

    PMID: 21784540BACKGROUND

  • Bragadottir G, Redfors B, Ricksten SE. Effects of levosimendan on glomerular filtration rate, renal blood flow, and renal oxygenation after cardiac surgery with cardiopulmonary bypass: a randomized placebo-controlled study. Crit Care Med. 2013 Oct;41(10):2328-35. doi: 10.1097/CCM.0b013e31828e946a.

    PMID: 23921271BACKGROUND

MeSH Terms

Conditions

Shock, CardiogenicCardio-Renal SyndromeAcute Kidney Injury

Interventions

Simendan

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShockRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHeart Failure

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Marco Maggiorini

    Medizinische Intensivstation D-HOER 27, UniversitatsSpital Zürich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2021

First Posted

June 8, 2021

Study Start

June 30, 2011

Primary Completion

April 30, 2014

Study Completion

April 30, 2014

Last Updated

June 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share