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Completed

NCT Number: NCT07186062

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levosimendan

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

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

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.

Primary outcomes

  1. renal function parameters.

    Time frame: 7 days

    Changes in serum creatinine (mg/dl). Pre- and post-infusion values were compared to assess treatment response.

  2. renal function

    Time frame: 7 days

    Changes in serum BUN (mg/dl). Pre- and post-infusion values were compared to assess treatment response.

  3. renal function

    Time frame: 7 days

    Changes in eGFR (mL/min/1.73 m²). Pre- and post-infusion values were compared to assess treatment response.

  4. renal function

    Time frame: 7 days

    Changes in urine output (mL/day). Pre- and post-infusion values were compared to assess treatment response.

  5. cardiac function

    Time frame: 7 days

    changes in ejection fraction % by transthoracic echocardiography. Pre- and post-infusion values were compared to assess treatment response.

  6. cardiac function

    Time frame: 7 days

    Changes in cardiac index (L/min/m²) measured by EV1000 clinical platform device. Pre- and post-infusion values were compared to assess treatment response.

  7. cardiac function

    Time frame: 7 days

    changes in stroke volume variations (SVV) measured by EV1000 clinical platform. Pre- and post-infusion values were compared to assess treatment response.

  8. cardiac function

    Time frame: 7 days

    changes in systemic vascular resistance index (SVRI) using EV1000 clinical platform device. Pre- and post-infusion values were compared to assess treatment response.

Secondary outcomes

  1. morbidity

    Time frame: 28 day

    length of ICU stay (days).

  2. morbidity

    Time frame: 28 day

    Total hospital stay (days)

  3. morbidity

    Time frame: 28 day

    ICU readmission

  4. mortality

    Time frame: 28 day

    In-hospital mortality.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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