The objective of this study is to investigate whether Levosimendan is able to lower creatinine levels as a measure of kidney failure and if urinary output can be increased.
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate in ICU patients with AKI defined by an increase of NGAL whether
Levosimendan can improve kidney function by an improved eCC of 10 ml per minute
within 72 hours.
Secondary outcome
Improvement of renal oxygenation
Improvement of eGFR and urine output
Evaluate Cardiac Output
Evaluation of Cardiac Biomarkers
Evaluate indication for renal replacement therapy
To assess mortality on day 28
Background summary
The aim of the study is to evaluate if Levosimendan in adult ICU patients with
AKI can improve kidney function
Study objective
The objective of this study is to investigate whether Levosimendan is able to
lower creatinine levels as a measure of kidney failure and if urinary output
can be increased.
Study design
This trial is set up as a pilot for a larger randomized intervention trial
including 68 patients, randomized into two cohorts. The experimental group
receives standard treatment supplemented by levosimendan for 24 hours
following onset of AKI and control group is to receive standard care as defined
by our local care protocols, combined with a placebo for levosimendan.
Intervention
Levosimendan infusion versus placebo infusion
Study burden and risks
The risk for participating patients in the investigation is limited. This trial
is building on foreign research done with levosimendan which has been
demonstrated to be beneficial in many patient groups, including patients with
renal problems. Biomarker measurements currently find good use in Dutch
intensive care units, and should be considered routine practice within the ICU
setting. In the opinion of the investigators, this trial is considered a low
risk for patients. In the opinion of the investigators the burden of this trial
is limited but the potential benefits could be quite large as improved renal
function has been demonstrated to be indicative of a more preferable outcome.
Tegelseweg 210
Venlo 5912BL
NL
Tegelseweg 210
Venlo 5912BL
NL
Listed location countries
Age
Inclusion criteria
*Over age of 18
*Informed consent is received
*Admitted to ICU
*Receiving diagnosis AKI with RIFLE criteria risk score *Injury (I) ***
(***For diagnosis of AKI, an previous serum creatinine value has to be available in the electronic patient record. However, creatinine is known for its fluctuations, mainly in critically ill patients. Therefore, for diagnosis of AKI, the serum creatinine at moment of possible inclusion in our trial will be compared to a previous value which is a maximum of 14 days old)
Exclusion criteria
*Failure to obtain written consent to participate from patient or legal representative (by deferred consent)
*Patients entering the ICU for post-operative observation with an estimated length of stay less than 24 hrs
*Moribund patients
*Patients under the age of 18
*Pregnancy
*Patients with mono kidney or just one functional kidney (i.e: contracted kidneys)
*Patients with post renal obstruction of any cause
*Renal replacement therapy initiated before admission due to Chronic Kidney Disease or predialysis
*Hypersensitity to levosimendan experienced by previous treatments
*Severe hypotension (MAP<60mmHg) and/or tachycardia (>180bpm) despite measures
*Significant pre-existing mechanical obstruction affecting ventricular filling or outflow or both
(*** Mechanical obstruction is defined as an *mild* or * moderate* in severity, as judged by the cardiologist performing previous echocardiogram)
*Severe hepatic impairment (ALAT/ASAT>400U/L)
*Patients will be excluded if the treating physician judges that study participation is undesirable due to an assumed short life expectancy
*Known history of Torsades de Pointes
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-004979-39-NL |
| ClinicalTrials.gov | NCT01720030 |
| CCMO | NL42546.068.14 |