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临床试验/NCT07186062
NCT07186062已完成不适用

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

Ain Shams University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
renal function parameters.

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Levosimendan group

干预措施: Levosimendan (Drug)

Dobutamine group

干预措施: Dobutamine (Drug)

Milrinone group

干预措施: Milrinone (Drug)

结局指标

主要结局

renal function parameters.

时间窗: 7 days

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

renal function

时间窗: 7 days

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

cardiac function

时间窗: 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.

次要结局

  • morbidity(28 day)
  • mortality(28 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Khaled Abdou

assistant professor

Ain Shams University

研究点 (1)

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