Levosimendan in Acute Kidney Injury Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

We hypothesise that levosimendan will have a positive influence on renal function during acute kidney injury in adult intensive care patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Levosimendan in Acute Kidney Injury After Cardiac Surgery

NCT02531724

Acute Kidney Injury Renal Insufficiency, Acute

COMPLETED PHASE4

Outcomes of Critically Ill Patients With Severe Acute Kidney Injury Requiring Renal Replacement Therapy

NCT02897310

Critical Illness Acute Kidney Injury

COMPLETED

Uremic Toxins in the Intensive Care Units (ICU): Patients With Lactate Acidosis

NCT00752453

Acute Renal Failure

COMPLETED NA

Natural History of Mineral Metabolism Parameters and Protein-bound Toxins in Incident Peritoneal Dialysis Patients

NCT01306149

Complication of Peritoneal Dialysis

COMPLETED

Uremic Toxins in the Intensive Care Unit (ICU): Patients With Sepsis

NCT00752245

Renal Failure Multi Organ Failure

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this trial is to evaluate whether the use of levosimendan is able to improve renal function.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Kidney Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional therapy

Standard of care as protocolized locally

Group Type PLACEBO_COMPARATOR

Conventional therapy

Intervention Type DRUG

Placebo therapy to safeguard blinding

Levosimendan

The experimental group receives standard treatment supplemented by levosimendan (0.2 µg/kg/min) for 24 hours within 36 hrs following onset of AKI.

Group Type EXPERIMENTAL

Levosimendan

Intervention Type DRUG

Verum therapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Levosimendan

Verum therapy

Intervention Type DRUG

Conventional therapy

Placebo therapy to safeguard blinding

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Simdax (R) Standard care plus placebo comparator

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinically diagnosed adult patients with AKI

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 suffering from pre-existing renal failure (elevated NGAL values without apparent rise in creatinine values)
* Renal replacement therapy initiated before admission due to Chronic Kidney Disease
* Hypersensitivity to levosimendan experienced by previous treatments
* Severe hypotension and tachycardia
* Significant mechanical obstruction affecting ventricular filling or outflow or both.
* Severe hepatic impairment (ALAT/ASAT\>400U/L)
* Patients will be excluded if the treating physician judges that study participation is undesirable for medical, medical-ethical or other reasons
* Known history of Torsades de Pointes

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No