Preservation of renal function in cardiac surgery patients with low cardiac output syndrome: levosimendan vs beta agonists
| ISRCTN | ISRCTN46058317 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46058317 |
| Secondary identifying numbers | CEIMAN-26-2-14/BGC |
- Submission date
- 28/06/2019
- Registration date
- 07/10/2019
- Last edited
- 19/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Campus Teatinos Sn Hu Virgen De La Victoria
Malaga
29006
Spain
| Phone | +34 (0)951032229 |
|---|---|
| guerreroorriach@gmail.com |
Study information
| Study design | Quasi-experiment study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Preservation of renal function in cardiac surgery patients with low cardiac output syndrome: levosimendan vs beta agonists |
| Study acronym | CEIMAN-26-2-14/BGC |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2015 |
| Completion date | 01/05/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 100 |
| Key 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 |
| Key exclusion criteria | 1. Patients who required combined surgery (not only cardiac surgery) 2. Emergency surgery 3. Preoperative diagnosis of chronic kidney failure |
| Date of first enrolment | 01/02/2015 |
| Date of final enrolment | 01/05/2018 |
Locations
Countries of recruitment
- Spain
Study participating centre
Malaga
29006
Spain
Sponsor information
Research organisation
Calle Dr. Miguel Díaz Recio, 28
Malaga
29010
Spain
| Phone | +34 (0)951440260 |
|---|---|
| fimabis@fimabis.org | |
"ROR" |
https://ror.org/002nw1r81 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/07/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in BMC Anesthesiology. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/11/2019 | 19/11/2019 | Yes | No |
Editorial Notes
19/11/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
05/07/2019: Trial's existence confirmed by ethics committee.
