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临床试验/NCT06533124
NCT06533124已完成不适用

Parameters of Cardiac Indices on the Ultrasonic Cardiac Output Monitor As Potential Indicators for Predicting the Achievement of Ultrafiltration Endpoint for Acute Heart Failure Treatment

Shanghai Tong Ren Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Brain natriuretic peptide

研究概览

简要总结

Background: The feasibility of the ultrasonic cardiac output monitor (USCOM)applying for determining ultrafiltration (UF) endpoints during acute heart failure (AHF) treatments was evaluated.

Methods: AHF patients were randomly assigned to UF (U, N=20) and USCOM+UF (UU, N=20) groups. The primary endpoint was differences in the hemodynamics of patients receiving UF alone or UF+USCOM. A prediction model was established.

详细描述

This study was based on the ACC/AHA/HFSA guidelines for the management of heart failure and involved 40 patients diagnosed with acute decompensated heart failure (ADHF) from January 2022 to July 2023. Patients were randomly assigned to UF (U, N = 20) and USCOM + UF (UU, N = 20) groups.

The inclusion criteria were: (1) Age ≥ 18 years; (2) Male or non-pregnant female patients; (3) Fluid overload manifested by at least two of the following: a) Pitting edema ≥ 2+ of the lower extremities; b) Moist rales in the lungs; c) Jugular venous distention > 10 cm; d) Pulmonary edema or pleural effusion on chest x-ray; e) Paroxysmal nocturnal dyspnea or ≥ two-pillow orthopnea; f) Congestive hepatomegaly or ascites; e) B-type natriuretic peptide (BNP) > 400 pg/mL.

The exclusion criteria were: (1) Hematocrit > 45%; (2) Systolic blood pressure ≤ 90 mmHg and poor peripheral circulation; (3) Contraindications to heparin anticoagulation;(4) Renal insufficiency with a Scr ≥ 3.0 mg/dl or planned renal replacement therapies; (5) Acute coronary syndromes; (6) Life-threatening organ dysfunction caused by a dysregulated host response to infection; (7) Active myocarditis; (8) patients with heart failure attributed to restrictive or hypertrophic cardiomyopathy or uncorrected valvular stenotic disease; (9) infection; (10) malignancies; (11) systemic immune disease; (12) unwillingness to cooperate; (13) withdrawal from the study or death. The study adhered to the principles of the Declaration of Helsinki and the protocols were approved by the Institutional Review Board of our hospital (2019-072-01). Informed consent was obtained from all enrolled patients.

Randomization:

Patients were randomly assigned in a 1:1 ratio, with one group receiving UF treatment alone and the other receiving UF treatment plus USCOM monitoring. The allocation of study participants was processed through an interactive web response system with a non-stratified permutated block size. Treating clinicians were unaware of patients' group assignments; there were a total of 40 patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

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

  • Age ≥ 18 years.
  • Male or non-pregnant female patients.
  • Fluid overload manifested by at least two of the following:
  • Pitting edema ≥ 2+ of the lower extremities
  • Moist rales in the lungs
  • Jugular venous distention > 10 cm
  • Pulmonary edema or pleural effusion on chest x-ray
  • Paroxysmal nocturnal dyspnea or ≥ two-pillow orthopnea
  • Congestive hepatomegaly or ascites
  • B-type natriuretic peptide (BNP) > 400 pg/mL

排除标准

  • Hematocrit > 45%.
  • Systolic blood pressure ≤ 90 mmHg and poor peripheral circulation.
  • Contraindications to heparin anticoagulation.
  • Renal insufficiency with a Scr ≥ 3.0 mg/dl or planned renal replacement therapies.
  • Acute coronary syndromes.
  • Life-threatening organ dysfunction caused by a dysregulated host response to infection.
  • Active myocarditis.
  • patients with heart failure attributed to restrictive or hypertrophic cardiomyopathy or uncorrected valvular stenotic disease.
  • infection.
  • malignancies.
  • systemic immune disease.
  • unwillingness to cooperate.
  • withdrawal from the study or death.

结局指标

主要结局

Brain natriuretic peptide

时间窗: One week

BNP, Brain natriuretic peptide, unit of measure: pg/ml.

Cardiac output was monitored using a non-invasive ultrasonic cardiac output monitor, which employed transaortic or transpulmonary Doppler flow tracing and estimated the valve area using a patient's height to estimate their cardiac output.

时间窗: One week

SVV, systemic vascular variation, unit of mesure:%

次要结局

未报告次要终点

研究者

发起方
Shanghai Tong Ren Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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