faculty of medicine Ain shams University
Cairo, Egypt
NCT Number: NCT07186062
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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Notify Me18 year and older
All sexes
Observational
Cairo, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cases were excluded from the study if they met any of the following criteria:
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.
Inotropic agents titrated to response to keep mean arterial blood pressure above 55 mmHg :
Inotropic agents titrated to response to keep mean arterial blood pressure above 55 mmHg :
Time frame: 7 days
Changes in serum creatinine (mg/dl). Pre- and post-infusion values were compared to assess treatment response.
Time frame: 7 days
Changes in serum BUN (mg/dl). Pre- and post-infusion values were compared to assess treatment response.
Time frame: 7 days
Changes in eGFR (mL/min/1.73 m²). Pre- and post-infusion values were compared to assess treatment response.
Time frame: 7 days
Changes in urine output (mL/day). Pre- and post-infusion values were compared to assess treatment response.
Time frame: 7 days
changes in ejection fraction % by transthoracic echocardiography. Pre- and post-infusion values were compared to assess treatment response.
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.
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.
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.
Time frame: 28 day
length of ICU stay (days).
Time frame: 28 day
Total hospital stay (days)
Time frame: 28 day
ICU readmission
Time frame: 28 day
In-hospital mortality.
Ain Shams University
Other
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