Condition category
Circulatory System
Date applied
28/06/2019
Date assigned
07/10/2019
Last edited
07/10/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Research has been conducted to assess the effects of the drug levosimendan on heart function when given to patients with low cardiac output syndrome (LCOS) in the period immediately after heart surgery. Postoperative kidney failure is an independent predictor of mortality. Levosimendan is used for LCOS and – apart from its cardioprotective effects – seems to have a protective role on kidney function. The aim of this study is to find out whether the use of levosimendan as compared to beta-agonists in heart surgery patients with LCOS and kidney failure has beneficial effects on kidney function that are independent from its cardioprotective effects.

Who can participate?
Patients with low cardiac output syndrome (LCOS)

What does the study involve?
Participants are treated with either beta-agonists or levosimendan. The incidence of postoperative kidney failure is assessed.

What are the possible benefits and risks of participating?
These are the same as usual treatment.

Where is the study run from?
HU Virgen de la Victoria (Spain)

When is the study starting and how long is it expected to run for?
January 2015 to May 2018

Who is funding the study?
FIMABIS (Spain)

Who is the main contact?
Dr Jose Luis Guerrero Orriach
guerreroorriach@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jose Luis Guerrero Orriach

ORCID ID

Contact details

Campus Teatinos Sn Hu Virgen De La Victoria
Malaga
29006
Spain
+34 (0)951032229
guerreroorriach@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CEIMAN-26-2-14/BGC

Study information

Scientific title

Preservation of renal function in cardiac surgery patients with low cardiac output syndrome: levosimendan vs beta agonists

Acronym

CEIMAN-26-2-14/BGC

Study hypothesis

It is postulated that the use of levosimendan as compared to beta-agonists in cardiac surgery patients with LCOS and kidney failure exerts beneficial preconditioning effects on renal function that are independent from its cardioprotective effects.

Ethics approval

Approved 27/02/2014, CEI Malaga Norte (Hospital Regional Universitario, 7ª planta Pabellón A, Avda. –Carlos Haya s/n, 29010-Málaga, Spain; Tel: +34 (0)951 29 1447/+34 (0)951 29 1977), no reference numbers attached

Study design

Quasi-experiment study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Low cardiac output syndrome (LCOS)

Intervention

It was a quasi-experiment study used to estimate the causal impact of an intervention on the target population without random assignment. Quasi-experimental research shares similarities with the traditional experimental design or randomized controlled trial, but it specifically lacks the element of random assignment to treatment or control. As it was a quasi-experimental study, recruitment was maintained until 50 patients were reached in each of the groups.

Patients were divided into two groups based on the therapy received, namely beta-agonists vs levosimendan. The administration of beta-agonists was maintained until LCOS resolution, whereas levosimendan was administered for 24 h at a rate of 0.1 mcg/kg/min at a target dose of 12.5 mg. The objectives of the therapy included a CI >2 l/min/m2 with a central venous saturation > 65% following volume replacement. Data were collected during the preoperative (heart and renal function data prior to surgery) and intraoperative period, at diagnosis of LCOS, at 24 h and at 48 h after diagnosis (24 h following completion of levosimendan therapy) and at discharge from the ICU.

Intervention type

Drug

Phase

Not Applicable

Drug names

Levosimendan, beta agonists

Primary outcome measure

Renal function parameters:
1. Creatinine measured using ELISA at baseline, 24 and 48 hours and ICU discharge
2. Stage of renal failure measured by the Acute renal failure (AKI) scale at baseline, 24 and 48 hours and ICU discharge
3. Diuresis and use of diuretics (mg of furosemide) measured using diuresis output at baseline, 24 and 48 hours and ICU discharge
4. Requirement of renal replacement therapy measured using dialysis therapy at ICU discharge

Secondary outcome measures

Hemodynamics:
1. HR (arrhythmia de novo) measured using EKG at baseline, 24 and 48 hours and ICU discharge
2. Multifocal atrial tachycardia (MAT) measured using EKG at baseline, 24 and 48 hours and ICU discharge
3. Heart failure (HF) measured using locs definition at baseline, 24 and 48 hours and ICU discharge
4. Ejection fraction of the left ventricle (EFLV) measured using Echo at baseline, 24 and 48 hours and ICU discharge
5. SvcO2 measured using oximetry at baseline, 24 and 48 hours and ICU discharge
6. Central venous pressure (CVP) measured using pressure transductor at baseline, 24 and 48 hours and ICU discharge

Overall trial start date

01/01/2015

Overall trial end date

01/05/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients older than 18 years who developed postoperative low cardiac output syndrome (LCOS) following heart surgery
2. LCOS (was defined as: a cardiac index < 2l/min/m2, or central venous saturation <65% after volume replacement) . It was checked by echocardiogram and Mostcare® (continuous cardiac index monitoring)
3. Patients who required inotropic support for the treatment of LCOS

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Patients who required combined surgery (not only cardiac surgery)
2. Emergency surgery
3. Preoperative diagnosis of chronic kidney failure

Recruitment start date

01/02/2015

Recruitment end date

01/05/2018

Locations

Countries of recruitment

Spain

Trial participating centre

Hu Virgen De La Victoria
Campus Teatinos SN
Malaga
29006
Spain

Sponsor information

Organisation

FIMABIS

Sponsor details

Calle Dr. Miguel Díaz Recio
28
Malaga
29010
Spain
+34 (0)951440260
fimabis@fimabis.org

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

FIMABIS

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in BMC Anesthesiology.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/07/2019

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/07/2019: Trial's existence confirmed by ethics committee.