The Role of Bioimpedance Analysis in Overweight and Obese Patients With Acute Heart Failure: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Development of acute kidney injury
研究概览
简要总结
Patients with heart failure (HF) have poor prognosis with high mortality and readmission rates. Diuretic therapy is the usual way of managing congestion, but sometimes is difficult to determine when we have reached euvolemia. Even in overweight and obese patients in which physical examination and usual diagnostic techniques have strong limitations. The aim of this study is to investigate the usefulness of bioelectrical impedance analysis (BIA) in management and treatment of HF in overweight and obese patients.
The study included overweight and obese patients who were admitted with acute decompensated HF. The study population was randomized into two arms: BIA-guided therapy or standard care. Serum electrolytes, kidney functions and natriuretic peptides were followed up during their hospital stay and at 90 days after discharge.
The primary endpoint was development of acute kidney injury (AKI) stage III (AKIN-III) during hospitalization and the main secondary endpoint was the reduction of NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels during hospitalization and within 90 days after discharge.
详细描述
Design: This study was designed as a single-center, single-blind, randomized controlled trial conducted at Hospital Fundación Jimenez Diaz (Madrid, Spain) from February 2020 to December 2021. It is a pilot study which has the objective of obtaining significant results in order to conduct a major research in the future with the purpose of including broadly the use of BIA in HF management. This study was approved by an institutional review committee and performed under Helsinki Declaration Guidelines. All patients provided written informed consent to participate.
Study Procedures All patients included in the study were measured weight and height at admission, and blood tests with hemogram and serum biochemistry including cardiac biomarkers such as NT-proBNP and troponin I were also ordered.
In the first 24 hours after admission an echocardiogram, a lung ultrasound (LUS) and a BIA were done in all patients. BIA was always performed by nephrologists from our hospital not involved in the patient's clinical care. BIA analysis to achieve assessments of fluid status, especially dry-weight, was performed with the portable Biomasc touch i8 (MaltronInternationl, Essex, UK). During the hospitalization period, blood parameters were measured according to standard clinical practice in all patients, with the condition of taking a blood chemistry including NT-proBNP on the day of discharge.
All patients were followed up for 90 days with a new complete blood test including NT-proBNP.
Eligible patients were randomized into two groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized for Acute Heart Failure (first episode or decompensation), based on Framingham criteria and NT-ProBNP>300 pg/ml
- •Body mass index greater than or equal to 25 kg/m2 at admission.
排除标准
- •Hemodynamic instability,
- •Chronic kidney disease with estimated glomerular filtration rate (eGFR) <15 ml/min/1.73m2, Pregnancy,
- •Amputated patients,
- •Chronic treatment with corticosteroids,
- •Severe valvular heart disease with indication for intervention,
- •Dementia or life-expectancy of 1 year or less with high probability for noncompliance with the study protocol.
结局指标
主要结局
Development of acute kidney injury
时间窗: Through hospitalization, an average of 7 days
Rate of patients with acute kidney injury (AKI) during hospitalization, defined as an increase in serum creatinine by \>0.5 mg/dL (AKIN classification stage III)
次要结局
- NT-proBNP reduction >30% during hospitalization(Through hospitalization, an average of 7 days)
- Length of stay in hospital.(Through hospitalization, an average of 7 days)
- The combined endpoint of all-cause death, rehospitalization for HF or visit to the ED because of congestion symptoms measured at 90 days after discharge(90 days after discharge.)
- levels of NT-proBNP levels <1.000 pg/mL(90 days after discharge.)