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Spanish Randomized Clinical Trial to Compare Levosimendan Versus Placebo in Postoperative Cardiac Surgery (SPARTANS) (SPARTANS)

Primary Purpose

Cardiac Output, Low

Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Levosimendan
Placebos
Sponsored by
María de los Ángeles Tena Pajuelo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Output, Low focused on measuring Poor left ventricule eyection fraction, Levosimendan, Cardiac surgery, Preoperative Treatment, Low cardiac output syndrome, Clinical Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Written informed consent
  • LVEF ≤35% detected by echocardiography carried out at least one week before surgery.
  • Scheduled AVR or/and Scheduled CABG with CBP.

Exclusion Criteria:

  • Previous levosimendan administration.
  • Emergency operation.
  • Kidney or liver trasplant or awaiting it.
  • Hepatic cirrhosis Child C. In case Child B, contact coordinating center.
  • Any degree of preoperative right ventricular failure.
  • Preoperative creatinine > 2 mg / dl.
  • Valve desease other than aortic.
  • Renal failure requering dialysis (or creatinine clearance < 30ml / min).
  • Hemodynamic instability (need for inotropics, unstable angina, acute myocardial infarction, intra-aortic balloon pump).
  • Patients underwent previous cardiac surgery.
  • Allergy or hypersensitivity to levosimendan or any of its excipients
  • Severe hypotension (sistolic arterial tension < 80 mmHg or mean arterial pressure <50 mmHg ) and tachycardia ( heart rate >130 bpm).
  • History of Torsades de Pointes.
  • Pregnancy or breast-feeding

Sites / Locations

  • GERMANS TRIAS I PUJOL DE BADALONA university Hospital
  • Doctor Josep Trueta university Hospital
  • Doctor Negrin University HospitalRecruiting
  • Puerta del Hierro University Hospital
  • Virgen de la Victoria University HospitalRecruiting
  • A coruña UNIVERSITY HOSPITAL COMPLEX A CORUÑARecruiting
  • 12 de Octubre University Hospital
  • Virgen Macarena University HospitalRecruiting
  • Valladolid universitary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Levosimemdam

Placebo

Arm Description

Levosimendan 2.5 mg / ml concentrate for solution for infusion. A 5 ml vial contains 12.5 mg of levosimendan. The concentrate is a clear solution, yellow or orange, for dilution before administration. The study drug infusion will start one day before surgery in an Intensive Care Unit with at least 8 hours of administration before surgery. A continuous infusion at 0.1 µg/kg/min will be administered to complete 24h duration.

Patients in the placebo group will receive a water-soluble vitamin B2 concentrate with 0.4 mg / ml sodium riboflavin phosphate to obtain the same color as the preparation of levosimendan and ethanol anhydrous 100 mg / ml to resemble the levosimendan odor, which will be administered at the same levosimendan infusion rate.

Outcomes

Primary Outcome Measures

Number of Participants with LCOS
LCOS will be considered if: 1) Postoperated cardiac index ≤2.0 L / min / m2 (liters / minute / square meter)
Number of Participants with LCOS
LCOS will be considered if: 2) The need to implant an intra-aortic balloon pump
Number of Participants with LCOS
LCOS will be considered if: 3) The need to implant a left ventricular assistance device
Number of Participants with LCOS
LCOS will be considered if: 4) To have a vasoactive inotropic scale (VIS) > 5.5 Vasoactive inotropic scale will be measured following the following formula: inotropic scale (IS) + 10 x Milrinone (μg / kg / min) + 100 x norepinephrine (μg / kg / min) + 10000 × vasopressin (U / kg / min). The inotropic scale (SI) will be calculated using the following formula: Dopamine (μg / kg / min) + Dobutamine (μg / kg / min) + 100 × adrenaline (μg / kg / min).

Secondary Outcome Measures

Composite event rate
includes the following options: 1) Death from any cause (proportion of patients with mortality from any case in each group Levo versus Placebo)
Composite event rate
includes the following options: 2) The need for renal replacement therapy or dialysis (proportion of patients in each group Levo versus Placebo)
Composite event rate
includes the following options: 3) LCOS (proportion of patients in each group Levo versus Placebo) It is calculated by adding the proportions of each of the 3 events described above.

Full Information

First Posted
November 11, 2019
Last Updated
July 22, 2020
Sponsor
María de los Ángeles Tena Pajuelo
Collaborators
Orion Corporation, Orion Pharma, Canary Foundation, Dr Negrin Hospital Statistician, Dr Negrin Hospital Farmacy, CRO TRIDE Asesores SL, QBE Europe SA/NV
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1. Study Identification

Unique Protocol Identification Number
NCT04179604
Brief Title
Spanish Randomized Clinical Trial to Compare Levosimendan Versus Placebo in Postoperative Cardiac Surgery (SPARTANS)
Acronym
SPARTANS
Official Title
Rationale and Design of a Multicenter Randomized Trial of Levosimendan to Reduce Low Cardiac Output Syndrome in Low Ejection Fraction (≤ 35%) Cardiac Surgery Patients. Spanish Randomized Clinical Trial on Levosimendan (SPARTANS Study)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 17, 2020 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
María de los Ángeles Tena Pajuelo
Collaborators
Orion Corporation, Orion Pharma, Canary Foundation, Dr Negrin Hospital Statistician, Dr Negrin Hospital Farmacy, CRO TRIDE Asesores SL, QBE Europe SA/NV

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Low cardiac output Syndrome (LCOS) is a complication that appears in approximately 20% of cardiac surgeries with extracorporeal circulation. LCOS is associated with increased mortality, delayed recovery and prolonged hospital stay. The Spanish Randomized Clinical Trial on Levosimendan (brand name: Sindax) (SPARTANS) aims to demonstrate the effectiveness of the preoperative use of Levosimendan in reducing LCOS in patients with poor left ventricle ejection fraction (LVEF) undergoing elective cardiac surgery. SPARTANS study is a multicenter, randomized triple-blind, placebo-controlled trial. 300 patients with LVEF ≤ 35%, undergoing elective cardiac surgery will be recruited from 9 Spanish hospitals and randomized into two groups: Preoperative administration of levosimendan or placebo for 24 hours. The study drug will be started as a continuous infusion (0.1 µg/kg/min) at least 8 hours before surgery to complete 24h duration. The primary endpoint will be 30-day LCOS. It will be evaluated using any of the following criteria: 1) postoperated cardiac index ≤2.0 L / min / m2, 2) a need to implant a intra-aortic balloon pump/ left ventricular assist device, 3) a vasoactive inotropic scale (VIS) > 5.5. The secondary end-point will be composite event rate at one year including any of the following events: death from any cause, need for renal replacement therapy or dialysis and LCOS. The sample size is based on the assumption that levosimendan reduces LCOS by 50% being necessary a sample size of 300 patients to carry out the study. The Research Team of each hospital, will carry out the clinical follow-up by telephone or clinical interview of the patient according to the time intervals: 30 days and 1 year. We estimate that the total sample size of 300 patients will be reached in 2-2.5 years. In conclusion, the effectiveness of levosimendan has not yet been reported with a good evidence in cardiac surgery. The purpose of the "Spanish Randomized Clinical Trial on Sindax" (SPARTANS) trial is to evaluate the beneficial effect of preoperative use of levosimendan compared with placebo to reduce perioperative LCOS in patients undergoing cardiac surgery with poor LVEF ≤ 35%.
Detailed Description
Low cardiac output syndrome (LCOS) is defined, by the Working Group of Cardiac Intensive Care of the Spanish Society of Intensive, Critical Medicine and Coronary Units, as a cardiac index (CI) <2.2 l / min / m2. LCOS is due to left and/or right ventricular failure and may be associated with pulmonary congestion and may occur with normal or low blood pressure. LCO after cardiac surgery is associated with increased mortality, delayed functional and organic recovery and prolonged stay in the Intensive Care Unit. It is characterized by a decrease in cardiac function, a reduction in oxygen supply and subsequent tissue hypoxia, together with signs of tissue hypoperfusion (peripheral coldness, confusion, oliguria and elevated lactate level) and in absence of hypovolemia. LCOS appears in approximately 20% of cardiopulmonary bypass (CPB) surgeries. Levosimendan, a calcium-sensitizing inotrope and an ATP-sensitive potassium channel opener, has been reported to be effective in decreasing LCOS and mortality after cardiac surgery. Simdax, which is its trade name, is indicated for the short-term treatment of severe acute decompensation of chronic heart failure in situations where conventional treatment is not sufficient or in cases where an inotropic support is considered appropriate. The recent publication of 2 large randomized clinical trials LEVO-CTS and LICORN failed to meet any benefit of levosimendan in terms of survival in cardiac surgery. Still, in a recently published meta-analysis, researchers showed that Levosimendan is effective in reducing low-cardiac output Syndrome compared to placebo (14.8% in the Levosimendan group versus 29.0% in the placebo group; RR = 0.40 , 95% CI = 0.22-0.73; P = 0.003). The purpose of the "Spanish Randomized Clinical Trial on Sindax" (SPARTANS) trial is to evaluate the beneficial effect of preoperative use of Levosimendan compared with placebo to reduce perioperative LCOS in patients undergoing cardiac surgery with poor LVF. The study was approved by the Ethical Committee of all participating centers. SPARTANS is a phase III, randomized, triple-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy of levosimendan in decrease perioperative LCOS in patients with preoperatively severe left ventricular dysfunction (LVEF ≤ 35%) who will be scheduled for cardiac surgery on CBP. The sample size was calculated based on an earlier meta-analysis (Tena MA, Urso S et al. Levosimendan versus placebo in cardiac surgery: a systematic review and a meta-analysis. Interact Cardiovasc Thorac Surg. 2018 27: 677-685) where researches document that Levosimendan is effective in reducing the rate of low postoperative cardiac output Syndrome compared to placebo (14.8% in the Levosimendan group versus 29.0% in the placebo group; RR = 0.40, 95% CI = 0.22-0.73; P = 0.003 ). Thus, considering a type I error of 0.05, a type II error of 0.20, a ratio of 1/1, an event rate of 29% in the Placebo group and an event rate of 15% in the Levosimendan group, a sample population of at least 137 patients for each group is required. Assuming a 9,5% patient drop rate, researches obtain a total sample of 300 patients (MedCalc Software bvba, Ostende, Belgium, http://www.medcalc.org, 2017). Thus, 300 patients will be enroll at 9 Spanish University hospitals scheduled for isolated aortic valve replacement (AVR) and/or coronary artery bypass grafting (CABG) with cardiopulmonary bypass (CPB). All enrolled patients will have a preoperative LVEF equal to, or less than 35 % detected by echocardiography measurement one week before surgery and will be required to give written informed consent, prior to being properly informed about participation in the trial, before enrollment. Researches hope to recruit 300 patients in 2 years. 150 patients will receive randomly levosimendan and another 150 patients placebo with identical appearance and doses to the medication under study. The study drug or placebo infusion will start one day before surgery in an Intensive Care Unit with at least 8 hours of administration before surgery. A continuous infusion at 0.1 µg/kg/min will be administered to complete 24h duration. If patients once randomized, suffering from one adverse event during the infusion, they will be registered stopping the infusion. In the case that the adverse event occurred in the postoperative period and if it was demonstrated due to the cause of the medication under study, it will be registered too. Researches will use a computer-generated permuted block randomization established by an independent statistician. Pharmacy of each hospital will prepare randomized treatment, without being involved in the trial. Patients and physicians will be blind to the randomized therapeutic strategy that each patient will receive. The data will be entered into a specific electronic database in an anonymized and dissociated manner. Patients Data will be collected by a Research Team for each participating hospital that will consist of at least one Cardiac Surgeon, an Anesthesiologist and a specialist in postoperative Critical Care. These investigators will receive training about patient selection and clinical events registration with the help of Contract Research Organization (CRO TRIDE ASESORES SL). This CRO will carry out regulatory execution of the trial, oversight and collection of electronic data, follow up and scientific regulation of procedures between different ethical Committees and hospitals involved. All data will be evaluated by trial main researcher and CRO identifying possible data collection errors and acting according to good clinical practice. The identification of a clinical event will be done by absolute majority by the members of the Research Team. Anesthesia, surgery and CBP will be performed according to standard operating procedures and following the usual clinical practice of each hospital. The primary endpoint is to demonstrate that preoperative levosimendan administration in patients undergoing AVR and/or CABG with poor LVEF ≤ 35% halve perioperative LCOS during the first 30 days of surgery. The secondary endopoint is to analyze composite event rate up to one year after surgery. The results will be expressed as means (±SD) or as medians and interquartile range to express quantitative variables. Qualitative variables will be expressed by frequency and percentage. Categorical variables will be compared by Fisher's exact test and continuous variables will be compared by Student's test or Mann-Whitney U. Incidence of composite endpoint will be compared between the two groups using a Chi-square test o Fisher's exact test. The Friedman or Anova test of repeated measures will be used to compare measures repeated through the study time. The risk factors will be expressed through relative risks (ratio of cumulative incidents), Odds Ratio or Hazard Ratio and their respective confidence intervals. Survival curves will be compared using the Log-rank test. All analyzes will be performed 2-sided and with an alpha level of 5%. All analyzes will be performed using the R program, version 3.5.2 or higher (R Foundation). The statistical calculation procedure will be carried out by an independent statistician and during the third year. Researches will follow the recommendations of Helsinki and Consort to carry out the trial and give greater validity to study results.The patients, sponsor or researchers included in trial will not receive financial compensation and declare that there has been no conflict of interest.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Output, Low
Keywords
Poor left ventricule eyection fraction, Levosimendan, Cardiac surgery, Preoperative Treatment, Low cardiac output syndrome, Clinical Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
SPARTANS is a phase II-III, prospective, randomized, triple-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy of levosimendan in decrease perioperative low cardiac output Syndrome in patients with preoperatively severe left ventricular dysfunction (LVEF ≤ 35%) who will be scheduled for cardiac surgery on cardipulmonary bypass. Follow-up duration will be one year.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Researches will use a computer-generated permuted block randomization established by an independent Statistician. Pharmacy of each hospital will prepare randomized treatment, without being involved in the trial. Patients and physicians will be blind to the randomized therapeutic strategy that each patient will receive. The data will be entered into a specific electronic database in an anonymized and dissociated manner.
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Levosimemdam
Arm Type
Experimental
Arm Description
Levosimendan 2.5 mg / ml concentrate for solution for infusion. A 5 ml vial contains 12.5 mg of levosimendan. The concentrate is a clear solution, yellow or orange, for dilution before administration. The study drug infusion will start one day before surgery in an Intensive Care Unit with at least 8 hours of administration before surgery. A continuous infusion at 0.1 µg/kg/min will be administered to complete 24h duration.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients in the placebo group will receive a water-soluble vitamin B2 concentrate with 0.4 mg / ml sodium riboflavin phosphate to obtain the same color as the preparation of levosimendan and ethanol anhydrous 100 mg / ml to resemble the levosimendan odor, which will be administered at the same levosimendan infusion rate.
Intervention Type
Drug
Intervention Name(s)
Levosimendan
Other Intervention Name(s)
SIMDAX
Intervention Description
Levosimendan SIMDAX 2.5 mg / ml concentrate for solution for infusion. The concentrate is a clear solution, yellow or orange, for dilution before administration. A 5 ml vial contains 12.5 mg of levosimendan. The study drug infusion will start one day before surgery in an Intensive Care Unit with at least 8 hours of administration before surgery. A continuous infusion at 0.1 µg/kg/min will be administered to complete 24h duration.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Patients in the placebo group will receive a water-soluble vitamin B2 concentrate with 0.4 mg / ml sodium riboflavin phosphate to obtain the same color as the preparation of levosimendan and ethanol anhydrous 100 mg / ml to resemble the levosimendan odor, which will be administered at the same levosimendan infusion rate.
Primary Outcome Measure Information:
Title
Number of Participants with LCOS
Description
LCOS will be considered if: 1) Postoperated cardiac index ≤2.0 L / min / m2 (liters / minute / square meter)
Time Frame
up to 30 days of cardiac surgery
Title
Number of Participants with LCOS
Description
LCOS will be considered if: 2) The need to implant an intra-aortic balloon pump
Time Frame
up to 30 days of cardiac surgery
Title
Number of Participants with LCOS
Description
LCOS will be considered if: 3) The need to implant a left ventricular assistance device
Time Frame
up to 30 days of cardiac surgery
Title
Number of Participants with LCOS
Description
LCOS will be considered if: 4) To have a vasoactive inotropic scale (VIS) > 5.5 Vasoactive inotropic scale will be measured following the following formula: inotropic scale (IS) + 10 x Milrinone (μg / kg / min) + 100 x norepinephrine (μg / kg / min) + 10000 × vasopressin (U / kg / min). The inotropic scale (SI) will be calculated using the following formula: Dopamine (μg / kg / min) + Dobutamine (μg / kg / min) + 100 × adrenaline (μg / kg / min).
Time Frame
up to 30 days of cardiac surgery
Secondary Outcome Measure Information:
Title
Composite event rate
Description
includes the following options: 1) Death from any cause (proportion of patients with mortality from any case in each group Levo versus Placebo)
Time Frame
up to one year after surgery
Title
Composite event rate
Description
includes the following options: 2) The need for renal replacement therapy or dialysis (proportion of patients in each group Levo versus Placebo)
Time Frame
up to one year after surgery
Title
Composite event rate
Description
includes the following options: 3) LCOS (proportion of patients in each group Levo versus Placebo) It is calculated by adding the proportions of each of the 3 events described above.
Time Frame
up to one year after surgery
Other Pre-specified Outcome Measures:
Title
Number of Patients with need for renal replacement therapy or dialysis
Description
Need for renal replacement therapy or dialysis in each group
Time Frame
up to 30 days
Title
Intensive Care Unit stay
Description
days in Intensive Care Unit Stay (calculate the average days of stay of all patients in each levo and placebo group)
Time Frame
until discharge from Intensive Care Unit
Title
Total post-surgical stay
Description
days from surgery to hospital discharge (arithmetic average)
Time Frame
until discharge from hospital
Title
Number of Patients with hospital cardiac mortality
Description
Hospital cardiac mortality
Time Frame
until discharge from hospital
Title
Number of Patients with need for ventricular assistance or intra-aortic balloon pump
Description
Need for ventricular assistance or intra-aortic balloon in each group
Time Frame
up to 1 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Written informed consent LVEF ≤35% detected by echocardiography carried out at least one week before surgery. Scheduled AVR or/and Scheduled CABG with CBP. Exclusion Criteria: Previous levosimendan administration. Emergency operation. Kidney or liver trasplant or awaiting it. Hepatic cirrhosis Child C. In case Child B, contact coordinating center. Any degree of preoperative right ventricular failure. Preoperative creatinine > 2 mg / dl. Valve desease other than aortic. Renal failure requering dialysis (or creatinine clearance < 30ml / min). Hemodynamic instability (need for inotropics, unstable angina, acute myocardial infarction, intra-aortic balloon pump). Patients underwent previous cardiac surgery. Allergy or hypersensitivity to levosimendan or any of its excipients Severe hypotension (sistolic arterial tension < 80 mmHg or mean arterial pressure <50 mmHg ) and tachycardia ( heart rate >130 bpm). History of Torsades de Pointes. Pregnancy or breast-feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Ángeles T Tena, cardiac surgery
Phone
617242203
Ext
+34
Email
doctora.tena@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Ángeles T Tena Pajuelo, Cardiac surgery
Organizational Affiliation
Doctor Negrin University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marta P Perez de Lis Novo, anesthesiology
Organizational Affiliation
A Coruña University Complex
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juan B Bustamante Munguira, Cardiac surgery
Organizational Affiliation
Valladolid UNIVERSITY CLINICAL HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc V Vives Santacana, anesthesiology
Organizational Affiliation
Doctor Joseh Trueta, Girona university clinical Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elisabet B Berastegui Garcia, Cardiac surgery
Organizational Affiliation
GERMANS TRIAS I PUJOL DE BADALONA University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pedro M Muñoz Ramirez, anesthesiology
Organizational Affiliation
12 de Octubre University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana Isabel G Gonzalez Roman, anesthesiology
Organizational Affiliation
Puerta del Hierro University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gemma S Sanchez Espin, Cardiac Surgery
Organizational Affiliation
Virgen de la Victoria University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emiliano Andres R Rodriguez Caulo, Cardiac Surgery
Organizational Affiliation
Virgen Macarena University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
GERMANS TRIAS I PUJOL DE BADALONA university Hospital
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabet B Berastegui Garcia, cardiac surgey
Phone
618849214
Ext
+34
Email
eberastegui.germanstrias@gencat.cat
Facility Name
Doctor Josep Trueta university Hospital
City
Girona
State/Province
Gerona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc V Vives Santacana, cardiac surgery
Phone
690277088
Ext
+34
Email
marcvives50@gmail.com
Facility Name
Doctor Negrin University Hospital
City
Las Palmas De Gran Canaria
State/Province
Gran Canarias
ZIP/Postal Code
35010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Angeles T Tena Pajuelo, Cardiac surgery
Phone
617242203
Ext
+34
Email
doctora.tena@gmail.com
Facility Name
Puerta del Hierro University Hospital
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Isabel G Gonzalez Roman, Anesthesiology
Phone
911 91 60 00
Ext
+34
Email
anaisgon@gmail.com
Facility Name
Virgen de la Victoria University Hospital
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gemma S Sanchez Espin, Cardiac Surgery
Phone
610466971
Ext
+34
Email
gsanchezespin@gmail.com
Facility Name
A coruña UNIVERSITY HOSPITAL COMPLEX A CORUÑA
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta P Perez de Lis Novo, Anesthesiology
Phone
986353555
Ext
+34
Email
zzizou9@hotmail.com
Facility Name
12 de Octubre University Hospital
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro M Muñoz Ramirez, Anesthiology
Phone
913 90 80 00
Ext
+34
Email
pedromram@gmail.com
Facility Name
Virgen Macarena University Hospital
City
Sevilla
ZIP/Postal Code
410019
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emiliano R Rodriguez Caulo, Cardiac Surgery
Email
erodriguezcaulo@hotmail.com
Phone
951405363
Ext
+34
Facility Name
Valladolid universitary Hospital
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan B Bustamante Munguira, Cardiac Surgery
Phone
983 420000
Ext
+34
Email
jbustamantemunguira@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Once the statistical analysis is completed during third year, the results of the study will be presented at the Congresses of the Spanish Society of Cardiothoracic Surgery. The informs and conclusions obtained by the statistical analysis of the study population will be sent for publication in impact journals. We will share all IPD that underlie results in a publication.
IPD Sharing Time Frame
From the fourth year of the study and they will be available indefinitely where it is published.
Citations:
PubMed Identifier
29718383
Citation
Tena MA, Urso S, Gonzalez JM, Santana L, Sadaba R, Juarez P, Gonzalez L, Portela F. Levosimendan versus placebo in cardiac surgery: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2018 Nov 1;27(5):677-685. doi: 10.1093/icvts/ivy133.
Results Reference
result
PubMed Identifier
19700350
Citation
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.
Results Reference
result
PubMed Identifier
24126568
Citation
Niu ZZ, Wu SM, Sun WY, Hou WM, Chi YF. Perioperative levosimendan therapy is associated with a lower incidence of acute kidney injury after cardiac surgery: a meta-analysis. J Cardiovasc Pharmacol. 2014 Feb;63(2):107-12. doi: 10.1097/FJC.0000000000000028.
Results Reference
result
PubMed Identifier
23620700
Citation
Levin R, Degrange M, Del Mazo C, Tanus E, Porcile R. Preoperative levosimendan decreases mortality and the development of low cardiac output in high-risk patients with severe left ventricular dysfunction undergoing coronary artery bypass grafting with cardiopulmonary bypass. Exp Clin Cardiol. 2012 Sep;17(3):125-30.
Results Reference
result

Learn more about this trial

Spanish Randomized Clinical Trial to Compare Levosimendan Versus Placebo in Postoperative Cardiac Surgery (SPARTANS)

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