The Effects of Levosimendan During Mitral Valve Surgery

NCT01969071 | Completed Phase 4 DMC

• 1 other identifier: No: 2013.2/1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The effects of levosimendan on renal function in patients with low ejection fraction undergoing mitral valve surgery will be investigated in a prospective, double-blinded, randomized clinical trial using serum creatinine (sCr)milligram in deciliter (mg/dL) values, calculated estimated glomerular filtration(eGFR)(ml/min/1.73 m2) rates and perioperative clinical follow-up parameters.

Conditions

Mitral Valve Stenosis With Incompetence or Regurgitation

Keywords

levosimendan; mitral valve surgery; cardiopulmonary bypass; serum creatinine; estimated glomerular filtration rate; ejection fraction

Outcome Measures

Primary Outcomes (1)

• The effects of levosimendan on renal function in patients with low ejection fraction undergoing mitral valve surgery.

  The effects of levosimendan on postoperative renal function measured by serum creatinine (sCr) levels and estimated glomerular filtration rate (eGFR).

  Between the time period of July 1, 2009 to January 30, 2013 participants will be followed for the duration of hospital stay, an expected average of 10 days.

Secondary Outcomes (1)

• The effects of levosimendan on renal function in patients with low ejection fraction undergoing mitral valve surgery.

  Between the time period of July 1, 2009 to January 30, 2013 participants will be followed for the duration of hospital stay, an expected average of 10 days.

Other Outcomes (1)

• The effects of levosimendan on renal function in patients with low ejection fraction undergoing mitral valve surgery

  Between the time period of July 1, 2009 to January 30, 2013 all patients will be evaluated participants will be followed for the duration of hospital stay, an expected average of 10 days.

Study Arms (2)

Levosimendan, inotropic agent

ACTIVE COMPARATOR

In the levosimendan group, levosimendan will be used in addition to standard inotropic therapy (one or more agent including; dopamine, dobutamine, noradrenaline, adrenaline)for 24 hours.Levosimendan dosage; a loading dose of levosimendan (6 μg kg-1) will be administered after removal of the aortic cross-clamp, followed by an infusion of levosimendan at a dose of 0.1 μg kg-1 min-1.

Drug: Levosimendan

Control

ACTIVE COMPARATOR

In the control group, only standard inotropic therapy (one or more agent including; dopamine, dobutamine, noradrenaline, adrenaline)will be administered

Drug: Dobutamine

Interventions

Levosimendan DRUG

The effects of levosimendan on renal function

Also known as: Symdax

Levosimendan, inotropic agent

Dobutamine DRUG

Standard Inotropic agent

Also known as: Dobutrex

Control

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of mitral valve insufficiency with or without coronary artery disease and a LVEF of ≤ 45 %.

You may not qualify if:

• unstable angina,
• diabetes mellitus treated with insulin, clinical findings of acute or chronic renal failure (sCr \> 1.5 mg dL-1),
• severe hepatic disease (alanine aminotransferase or aspartate aminotransferase \> 100 U litre L-1),
• severe chronic obstructive pulmonary disease (forced expired volume in 1 s \< 50 % of predicted or \< 2.0 litre),
• a history of prior CABG surgery or myocardial infarction (MI) within the previous month,
• emergent operations,
• patients on inotropic support before operation,
• aortic valvular disease, and
• infective endocarditis.

Sponsors & Collaborators

• Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital: lead

Study Sites (1)

Kartal Kosuyolu High Speciality Training and Research Hospital

Istanbul, 34846, Turkey (Türkiye)

Location

Related Publications (10)

• Nieminen MS, Akkila J, Hasenfuss G, Kleber FX, Lehtonen LA, Mitrovic V, Nyquist O, Remme WJ. Hemodynamic and neurohumoral effects of continuous infusion of levosimendan in patients with congestive heart failure. J Am Coll Cardiol. 2000 Nov 15;36(6):1903-12. doi: 10.1016/s0735-1097(00)00961-x.

  PMID: 11092663 BACKGROUND

• Garcia Gonzalez MJ, Dominguez Rodriguez A. Pharmacologic treatment of heart failure due to ventricular dysfunction by myocardial stunning: potential role of levosimendan. Am J Cardiovasc Drugs. 2006;6(2):69-75. doi: 10.2165/00129784-200606020-00001.

  PMID: 16555860 BACKGROUND

• Yilmaz MB, Yalta K, Yontar C, Karadas F, Erdem A, Turgut OO, Yilmaz A, Tandogan I. Levosimendan improves renal function in patients with acute decompensated heart failure: comparison with dobutamine. Cardiovasc Drugs Ther. 2007 Dec;21(6):431-5. doi: 10.1007/s10557-007-6066-7. Epub 2007 Oct 20.

  PMID: 17952581 BACKGROUND

• De Hert SG, Lorsomradee S, Cromheecke S, Van der Linden PJ. The effects of levosimendan in cardiac surgery patients with poor left ventricular function. Anesth Analg. 2007 Apr;104(4):766-73. doi: 10.1213/01.ane.0000256863.92050.d3.

  PMID: 17377079 RESULT

• Hernandez A, Miranda A, Parada A. [Levosimendan reduces mortality in cardiac surgery: a systematic review and meta-analysis]. Rev Esp Anestesiol Reanim. 2012 Jan;59(1):6-11. doi: 10.1016/j.redar.2012.02.001. Epub 2012 Mar 14. Spanish.

  PMID: 22429630 RESULT

• Severi L, Lappa A, Landoni G, Di Pirro L, Luzzi SJ, Caravetta P, Cipullo P, Menichetti A. Levosimendan versus intra-aortic balloon pump in high-risk cardiac surgery patients. J Cardiothorac Vasc Anesth. 2011 Aug;25(4):632-6. doi: 10.1053/j.jvca.2011.03.001. Epub 2011 May 4.

  PMID: 21546269 RESULT

• Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713.

  PMID: 17331245 RESULT

• Metra M, Nodari S, Parrinello G, Bordonali T, Bugatti S, Danesi R, Fontanella B, Lombardi C, Milani P, Verzura G, Cotter G, Dittrich H, Massie BM, Dei Cas L. Worsening renal function in patients hospitalised for acute heart failure: clinical implications and prognostic significance. Eur J Heart Fail. 2008 Feb;10(2):188-95. doi: 10.1016/j.ejheart.2008.01.011.

  PMID: 18279773 RESULT

• Haase-Fielitz A, Bellomo R, Devarajan P, Story D, Matalanis G, Dragun D, Haase M. Novel and conventional serum biomarkers predicting acute kidney injury in adult cardiac surgery--a prospective cohort study. Crit Care Med. 2009 Feb;37(2):553-60. doi: 10.1097/CCM.0b013e318195846e.

  PMID: 19114878 RESULT

• Elahi MM, Lim MY, Joseph RN, Dhannapuneni RR, Spyt TJ. Early hemofiltration improves survival in post-cardiotomy patients with acute renal failure. Eur J Cardiothorac Surg. 2004 Nov;26(5):1027-31. doi: 10.1016/j.ejcts.2004.07.039.

  PMID: 15519198 RESULT

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Simendan; Dobutamine

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Catecholamines; Amines; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Ayse Baysal, MD

  Kartal Kosuyolu High Speciality Training and Research H

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: October 25, 2013
• Study Start: July 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 25, 2013

Record last verified: 2013-09

Locations

TU (1)