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Clinical Outcomes of Levosimendan Versus Dobutamine Versus Milrinone in Cases With Acute Decompensated Heart Failure With Impaired Renal Function

Clinical Outcomes of Levosimendan Versus Dobutamine Versus Milrinone in Cases With Acute Decompensated Heart Failure With Impaired Renal Function

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07186062
Enrollment
60
Registered
2025-09-22
Start date
2022-06-01
Completion date
2024-06-01
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Decompensated Heart Failure (ADHF), Cardiorenal Syndrome (CRS)

Keywords

Levosimendan, dobutamine, Milrinone, Acute Decompensated Heart Failure (ADHF), Cardiorenal Syndrome (CRS)

Brief summary

This study aimed to assess and compare the cardiac, renal, and clinical efficacy of Levosimendan (LEV), Dobutamine (DOB), and milrinone (MIL) in cases with acute decompensated heart failure (ADHF) complicated by renal impairment, with a focus on their role in the management of cardiorenal syndrome (CRS).

Detailed description

Methods Upon ICU admission and once the clinical decision to initiate inotropic therapy was made, all enrolled patients underwent a standardized evaluation protocol that included: Comprehensive medical history and clinical examination. Laboratory assessments, including Complete blood count (CBC), Arterial blood gases (ABG), Liver and kidney function tests, Serum electrolytes, Random blood glucose, Estimated glomerular filtration rate (eGFR). Cardiac parameters were recorded by EV1000 clinical platform device to assess the cardiac index (CI), stroke volume variations (SVV), and systemic vascular resistance index (SVRI). at baseline, 24 hours after inotropic therapy initiation, and again on day 7 or prior to ICU discharge whichever occurred first. Renal function indicators \_including serum creatinine, blood urea nitrogen (BUN), eGFR, and urinary output\_ were measured before the start of infusion and monitored daily until ICU discharge or death. Medications were routinely administered as part of standard institutional practice. Where trial-specific medications were used, we have provided a clear distinction between these and routine medications. omission of medications not routinely used in our protocol did not cause harm to patients, and all treatments provided were in accordance with current safety standards and ethical guidelines. Inotropic agents titrated to response to keep mean arterial blood pressure above 55 mmHg : * Levosimendan: loading dose 6-12 microgram/ kg then continuous infusion of 0.05-0.2 µg/kg/min. * Dobutamine: continuous infusion starting at 2.5 µg/kg/min, titrated up to 20 µg/kg/min as needed. * Milrinone: 50 mcg/kg loading dose, then 0.375-0.75 mcg/kg/min IV according to patient response. Primary outcomes included changes in cardiac and renal function parameters. Pre- and post-infusion values were compared to assess treatment response. Secondary outcomes encompassed length of ICU stay, total hospital stay, ICU readmission, and all-cause in-hospital mortality.

Interventions

DRUGLevosimendan

Inotropic agents titrated to response to keep mean arterial blood pressure above 55 mmHg : •Levosimendan: loading dose 6-12 microgram/ kg then continuous infusion of 0.05-0.2 µg/kg/min.

DRUGDobutamine

Inotropic agents titrated to response to keep mean arterial blood pressure above 55 mmHg : • Dobutamine: continuous infusion starting at 2.5 µg/kg/min, titrated up to 20 µg/kg/min as needed.

DRUGMilrinone

Inotropic agents titrated to response to keep mean arterial blood pressure above 55 mmHg : • Milrinone: 50 mcg/kg loading dose, then 0.375-0.75 mcg/kg/min IV according to patient response.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult (\>18 years old) patients with ADHF (LVEF ≤ 40% documented prior to enrollment) admitted to the ICU with renal impairment (estimated GFR between 30 and 60 mL/min/1.73 m², calculated using the Modification of Diet in Renal Disease Study equation (MDRD equation)) and require inotropic support.

Exclusion criteria

Cases were excluded from the study if they met any of the following criteria: * Age younger than 18 years * Untreated acute HF * Resting heart rate exceeding 120 beats per minute * Recent MI or acute coronary syndrome within the previous two months * Diagnosed pulmonary embolism * Structural cardiac conditions * Known history of kidney disease diagnosed prior to HF * Administration of contrast agents or nephrotoxic drugs within the previous seven days * Severe liver dysfunction (Child C) * Active acute inflammatory or infectious diseases.

Design outcomes

Primary

MeasureTime frameDescription
renal function parameters.7 daysChanges in serum creatinine (mg/dl). Pre- and post-infusion values were compared to assess treatment response.
renal function7 daysChanges in serum BUN (mg/dl). Pre- and post-infusion values were compared to assess treatment response.
cardiac function7 dayschanges in ejection fraction % by transthoracic echocardiography. Pre- and post-infusion values were compared to assess treatment response.

Secondary

MeasureTime frameDescription
morbidity28 daylength of ICU stay (days).
mortality28 dayIn-hospital mortality.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026