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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).
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 :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levosimendan group |
| ||
| Dobutamine group |
| ||
| Milrinone group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| renal function parameters. | Changes in serum creatinine (mg/dl). Pre- and post-infusion values were compared to assess treatment response. | 7 days |
| renal function | Changes in serum BUN (mg/dl). Pre- and post-infusion values were compared to assess treatment response. | 7 days |
| renal function | Changes in eGFR (mL/min/1.73 m²). Pre- and post-infusion values were compared to assess treatment response. | 7 days |
| renal function | Changes in urine output (mL/day). Pre- and post-infusion values were compared to assess treatment response. | 7 days |
| cardiac function | changes in ejection fraction % by transthoracic echocardiography. Pre- and post-infusion values were compared to assess treatment response. | 7 days |
| cardiac function | 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 days |
| cardiac function | changes in stroke volume variations (SVV) measured by EV1000 clinical platform. Pre- and post-infusion values were compared to assess treatment response. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| morbidity | length of ICU stay (days). | 28 day |
| morbidity | Total hospital stay (days) | 28 day |
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Inclusion Criteria:
Exclusion Criteria:
Cases were excluded from the study if they met any of the following criteria:
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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) [10] and require inotropic support.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of medicine Ain shams University | Cairo | Egypt |
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| 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. |
|
| cardiac function |
changes in systemic vascular resistance index (SVRI) using EV1000 clinical platform device. Pre- and post-infusion values were compared to assess treatment response. |
| 7 days |
| morbidity | ICU readmission | 28 day |
| mortality | In-hospital mortality. | 28 day |
| ID | Term |
|---|---|
| D059347 | Cardio-Renal Syndrome |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077464 | Simendan |
| D004280 | Dobutamine |
| D020105 | Milrinone |
| ID | Term |
|---|---|
| D006835 | Hydrazones |
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D011724 | Pyridazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002395 | Catecholamines |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000676 | Amrinone |
| D000631 | Aminopyridines |
| D011725 | Pyridines |
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