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临床试验/NCT01140399
NCT01140399终止4 期

Impact of Different Therapeutic Approaches in Patients With Cardiorenal Syndrome in the Setting of Acute Decompensated Congestive Heart Failure (ADCHF)

Niguarda Hospital16 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2011年2月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
终止
入组人数
10
试验地点
16
主要终点
Changes in a composite clinical-lab score

研究概览

简要总结

The purpose of this study is to determine whether in patients with acute decompensated congestive heart failure and the cardiorenal syndrome, i.e. a state in which therapy directed to improve symptoms is limited by further worsening renal function, fluid removal by ultrafiltration is superior to different pharmacological approaches in acutely relieving congestion and preventing further deterioration in renal function and whether it results in longer admission-free survival 90 days after enrolment

详细描述

Acute decompensated congestive heart failure (ADCHF), the most common single cause of hospitalization over 65 years, results in 4-8% in-hospital mortality and 30-38% incidence of readmissions within 3 months after discharge. While fluid accumulation remains the main factor causing hospitalization, impaired cardiac output in ADHF causes renal arterial underfilling and increased venous pressure, reducing the glomerular filtration rate and causing acute kidney injury.

Aggressive therapy is required to alleviate volume overload during hospital admission and achievement of a dry weight is capital in preventing rehospitalisation. Currently diuretics are considered the standard of care for volume overload in ADHF, yet any patients, especially those with advanced HF become soon resistant to standard doses of loop diuretics, so escalating doses and the association of thiazides are often required to achieve effective diuresis, an approach that will progressively worsen renal function, causing the cardiorenal syndrome.

When diuretic resistance develops and symptoms persists, mechanical fluid removal via ultrafiltration should be considered. Ultrafiltration is an alternative method of sodium and water removal, that filters plasma water directly across a semipermeable membrane in response to a transmembrane pressure gradient, resulting in an ultrafiltrate that is isoosmotic compared with plasma water, In view of the limits of traditional therapies for the treatment of congestion and concomitant progressive renal dysfunction in ADHF patients, there is a compelling need for additional studies to individuate the better method for fluid removal in volume-overloaded patients and guide management decisions to reduce associated morbidity.

The main objectives of the present project are to evaluate whether in patients with acute decompensated congestive heart failure and the cardiorenal syndrome, i.e. a state in which therapy directed to improve CHF symptoms is limited by further worsening renal function, fluid removal by ultrafiltration is superior to different pharmacological approaches in acutely relieving congestion and preventing further deterioration in renal function and whether it results in longer admission-free survival 90 days after enrolment

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Infusional drug treatment

Active Comparator

Diuretics or diuretics plus fixed low dose dopamine infusion

干预措施: Furosemide or Furosemide and Dopamine (Drug)

Ultrafiltration

Experimental

Device: Ultrafiltration appliance Sessions of 8 h UF are conducted on 2 subsequent days in the first 48 hours after randomization; a third session is performed on day 3 in case of persistent congestion

干预措施: Ultrafiltration (Device)

结局指标

主要结局

Changes in a composite clinical-lab score

时间窗: Baseline and 96 h after randomization,precisely:48 h after end of the last UF session in the intervention arm;24 h after end of 72 h infusional drug treatment in the control arm

Changes in a score derived by summing up changes in dyspnea, weight loss, glomerular filtration rate (GFR), brain natriuretic peptide (BNP)

次要结局

  • Changes in the dyspnea Likert scale(Measured at day 4, at day 10, at day 90 vs baseline)
  • Changes in modified RIFLE (AKIN) stage(Measured at day 4 vs baseline)
  • Length of stay during index admission(Measured at average day 10)
  • Occurrence of major adverse events(Measured at day 90)
  • Days spent alive and out of hospital (DAOH) within 90 days(Measured at day 90)
  • BNP changes(Measured at day 0, at day 4, at 10 and day 90)
  • Changes in neutrophil gelatinase associated lipocalin (NGAL)(Measured at day -1, at day 0 and day 4)
  • Changes in Cystatin C (CysC)(Measured at day 0, day 4, day 10 and day 90)
  • Treatment-related adverse events(Measured at day 4)
  • Adverse changes in blood pressure, heart rate and rhythm(Measured at day 4)
  • Adverse changes in lab parameters(Measured at day 4)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (16)

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