se of levosimendan / placebo as cardio and nephroprotection in patients who are going 0n cardiac surgery with right ventricular dysfunctio

Phase 1

• Conditions: Perioperative right ventricle dysfunction; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2018-004063-31-ES
• Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-22
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

. Patients = 18 years
• Patients with preoperative right ventricular dysfunction (TAPSE <17 mm, RV dilatation> 39 mm, tricuspid annulus dilatation> 40 mm), diagnosed by preoperative transthoracic echocardiography.
• Give informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

. History of adverse event related to levosimendan.
• Patients in a situation of hemodynamic instability.
• Preoperative renal dysfunction, estimated through the preoperative GFR rate (creatinine clearance <50ml / min).
• Hypersensitivity to levosimendan or to any of the excipients.
• Significant mechanical obstructions affecting ventricular filling or emptying or both.
• History of Torsade de Pointes.
• Cardiogenic shock situation (lactate> 4 mmol / L)
• TAS before the infusion <100 mmHg (recommendation of the Spanish Society of Cardiology)
• Some serious situation at the discretion of the researcher.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified