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

NCT ID: NCT07186062

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-06-01

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Levosimendan group

Levosimendan

Intervention Type: DRUG

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 group

Dobutamine

Intervention Type: DRUG

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.

Milrinone group

Milrinone

Intervention Type: DRUG

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.

Interventions

Levosimendan

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.

Intervention Type: DRUG

Dobutamine

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.

Intervention Type: DRUG

Milrinone

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Khaled Abdou

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

faculty of medicine Ain shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU MD 185a/2022/2023

Identifier Type: -

Identifier Source: org_study_id