Brief Summary

Low cardiac output syndrome (LCOs) is a serious complication in critically ill patients or those undergoing major surgery, resulting in multiple organ damage with significant in-hospital and long-term morbidity and mortality, as well as prolonged hospital stay. In this setting the mortality rate is distressingly high despite improvements in intensive care treatment, but survivors have an acceptable quality of life.

Trial Health

On Track

Trial Health Score

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

Enrollment

1,000

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Nov 2009

Longer than P75 for phase_4

Geographic Reach

3 countries

18 active sites

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

6.5 years study duration

First Submitted

Initial submission to the registry

October 7, 2009

Completed

7 days until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed

18 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed

6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed

Last Updated

July 22, 2016

Status Verified

July 1, 2016

Enrollment Period

6.5 years

First QC Date

October 7, 2009

Last Update Submit

July 21, 2016

Conditions

Low Cardiac Output Syndrome

Keywords

levosimendancardiac surgerycardiac anesthesiamortalitysurvivalinotropic drugs

Outcome Measures

Primary Outcomes (1)

Mortality
30-days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

"Soluvit" ATC BO5XC (a mixture of vitamins with a yellow colour that is indistinguishable from the study drug Levosimendan) half ampul in 100 ml of glucose 5%

Drug: placebo

Levosimendan

EXPERIMENTAL

Levosimendan

Drug: Levosimendan

Interventions

LevosimendanDRUG

Also known as: simdax

Levosimendan

placeboDRUG

"Soluvit" ATC BO5XC (a mixture of vitamins with a yellow colour that is indistinguishable from the study drug Levosimendan) half ampul in 100 ml of glucose 5%

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Written informed consent
Age \> 18 years
Perioperative myocardial dysfunction

You may not qualify if:

Previous unusual response to levosimendan or soluvit or any of their components
Levosimendan administration in the previous 30 days
Parkinson's disease
Emergency operation
Kidney or liver transplant
Liver cirrhosis (Child B or C)
Decision to use ECMO (ECMO already started or planned)
Do not resuscitate patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Università Vita-Salute San Raffaelelead

Study Sites (18)

Santa Casa de Misericórdia de Juiz de Fora

Juiz de Fora, Minas Gerais, 36.021- 630, Brazil

Location

Policlinico S.Orsola-Malpighi

Bologna, Italy, 40138, Italy

Location

Azienda Ospedaliera Universitaria San Martino

Genova, Italy, 16132, Italy

Location

Azienda Ospedaliera Ospedali Riuniti Papardo - Piemonte

Messina, ME, 98158, Italy

Location

Azienda Ospedaliera Regionale San Carlo

Potenza, Potenza, 85100, Italy

Location

Ospedale Civile SS Annunziata

Sassari, Sassari, Italy

Location

A.O.U. Citta della Salute e della Scienza

Torino, TO, 10126, Italy

Location

A. O. Ordine Mauriziano di Torino

Torino, TO, Italy

Location

Ospedale San Bortolo

Vicenza, VI, Italy

Location

Azienda Ospedaliera Universitaria "Mater Domini"

Catanzaro, Italy

Location

Ospedale San Raffaele di Milano, Italy

Milan, 20132, Italy

Location

Ospedale San Gerardo di Monza

Monza, Italy

Location

Azienda Ospedaliera Specialistica dei Colli

Napoli, Italy

Location

Azienda Ospedaliera Universitaria Pisana

Pisa, Italy

Location

Astrakhan Federal Centre for Cardiac Surgery

Astrakhan, Russia, 414000, Russia

Location

Scientific Research Institute for Complex Issues of Cardiovascular Diseases

Kemerovo, Russia, 650002, Russia

Location

Moscow Regional Clinical & Research Institute

Moscow, Russia, 129110, Russia

Location

Research Institute of Circulation Pathology

Novosibirsk, Russia, 630055, Russia

Location

Related Publications (7)

Landoni G, Mizzi A, Biondi-Zoccai G, Bruno G, Bignami E, Corno L, Zambon M, Gerli C, Zangrillo A. Reducing mortality in cardiac surgery with levosimendan: a meta-analysis of randomized controlled trials. J Cardiothorac Vasc Anesth. 2010 Feb;24(1):51-7. doi: 10.1053/j.jvca.2009.05.031. Epub 2009 Aug 22.
PMID: 19700350BACKGROUND
Landoni G, Zambon M, Zangrillo A. Reducing perioperative myocardial infarction with anesthetic drugs and techniques. Curr Drug Targets. 2009 Sep;10(9):858-62. doi: 10.2174/138945009789108837. Epub 2009 Sep 1.
PMID: 19538174BACKGROUND
Zangrillo A, Biondi-Zoccai G, Mizzi A, Bruno G, Bignami E, Gerli C, De Santis V, Tritapepe L, Landoni G. Levosimendan reduces cardiac troponin release after cardiac surgery: a meta-analysis of randomized controlled studies. J Cardiothorac Vasc Anesth. 2009 Aug;23(4):474-8. doi: 10.1053/j.jvca.2008.11.013. Epub 2009 Feb 12.
PMID: 19217315BACKGROUND
Landoni G, Rodseth RN, Santini F, Ponschab M, Ruggeri L, Szekely A, Pasero D, Augoustides JG, Del Sarto PA, Krzych LJ, Corcione A, Slullitel A, Cabrini L, Le Manach Y, Almeida RM, Bignami E, Biondi-Zoccai G, Bove T, Caramelli F, Cariello C, Carpanese A, Clarizia L, Comis M, Conte M, Covello RD, De Santis V, Feltracco P, Giordano G, Pittarello D, Gottin L, Guarracino F, Morelli A, Musu M, Pala G, Pasin L, Pezzoli I, Paternoster G, Remedi R, Roasio A, Zucchetti M, Petrini F, Finco G, Ranieri M, Zangrillo A. Randomized evidence for reduction of perioperative mortality. J Cardiothorac Vasc Anesth. 2012 Oct;26(5):764-72. doi: 10.1053/j.jvca.2012.04.018. Epub 2012 Jun 20.
PMID: 22726656BACKGROUND
Landoni G, Biondi-Zoccai G, Greco M, Greco T, Bignami E, Morelli A, Guarracino F, Zangrillo A. Effects of levosimendan on mortality and hospitalization. A meta-analysis of randomized controlled studies. Crit Care Med. 2012 Feb;40(2):634-46. doi: 10.1097/CCM.0b013e318232962a.
PMID: 21963578BACKGROUND
Zangrillo A, Lomivorotov VV, Pisano A, Calabro MG, Belletti A, Brazzi L, Grigoryev EV, Guarracino F, Monaco F, Garofalo E, Crivellari M, Likhvantsev VV, Fominskiy EV, Paternoster G, Yavorovskiy A, Pasyuga VV, Oriani A, Lembo R, Bianchi A, Scandroglio AM, Abubakirov MN, Di Tomasso N, Landoni G; CHEETAH Study Group. Long-term outcome of perioperative low cardiac output syndrome in cardiac surgery: 1-year results of a multicenter randomized trial. J Crit Care. 2020 Aug;58:89-95. doi: 10.1016/j.jcrc.2020.04.005. Epub 2020 Apr 17.
PMID: 32402931DERIVED
Landoni G, Lomivorotov VV, Alvaro G, Lobreglio R, Pisano A, Guarracino F, Calabro MG, Grigoryev EV, Likhvantsev VV, Salgado-Filho MF, Bianchi A, Pasyuga VV, Baiocchi M, Pappalardo F, Monaco F, Boboshko VA, Abubakirov MN, Amantea B, Lembo R, Brazzi L, Verniero L, Bertini P, Scandroglio AM, Bove T, Belletti A, Michienzi MG, Shukevich DL, Zabelina TS, Bellomo R, Zangrillo A; CHEETAH Study Group. Levosimendan for Hemodynamic Support after Cardiac Surgery. N Engl J Med. 2017 May 25;376(21):2021-2031. doi: 10.1056/NEJMoa1616325. Epub 2017 Mar 21.
PMID: 28320259DERIVED

MeSH Terms

Conditions

Cardiac Output, Low

Interventions

Simendan

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

Alberto Zangrillo, MD
Vita-Salute University of Milano
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Head of Research, Anesthesia and Intensive Care Department

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 14, 2009

Study Start

November 1, 2009

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

July 22, 2016

Record last verified: 2016-07

Locations

RU(4)BR(1)IT(13)

Levosimendan in High Risk Patients Undergoing Cardiac Surgery

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Placebo

Levosimendan

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (18)

Related Publications (7)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Placebo

Levosimendan

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (18)

Related Publications (7)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations