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临床试验/NCT01441245
NCT01441245已完成4 期

Continuous Versus Intermittent Loop Diuretics Infusion Dosing in Acute Heart Failure: Effects on Renal Function, Outcome and BNP Levels

University of Siena1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
57
试验地点
1
主要终点
Evaluation of Mean Urine Output Volume During the Infusion Period

研究概览

简要总结

Intravenous loop diuretics is the therapy most commonly used to treat pulmonary congestion and systemic fluid overload. In theory, continuous infusion should allow for a more consistent diuresis, avoiding the sodium reabsorption in the distal tubule as well as the neurohormonal activation. This should lead to renal function improvement and BNP decrease.

详细描述

Patients were eligible if they were admitted with a primary diagnosis of ADHF, randomized within 12 h after hospital presentation, and with evidence of volume overload (pulmonary congestion) on a chest X-ray study and had BNP levels >100 pg/ml. Patients also displayed mild to moderate renal dysfunction with creatinine values up to 1.4 mg/dl. Some patients were supported with non invasive ventilation before randomization. Once the initial 12 h dose was determined, patients were randomized using a 1:1 ratio using a computer-generated scheme to receive the furosemide dose either divided into a twice-daily bolus injection or in a continuous infusion (mixed as a 1:1 ratio in 5 % dextrose in water) for a time period ranging from 72 to 120 h. The randomization was casual, and the physicians did not previously know the assigned arm. The dose escalation and subsequent titration of furosemide was guided by clinical response in terms of urine output volume and body weight reduction .Before randomization, renal function parameters and BNP levels were measured in all patients. Subsequent titration of the furosemide dosage was at the discretion of the attending physician, but was guided by a dose-escalation algorithm based on the treatment response (weight loss and urine output volume), symptom improvement, changes in renal function, electrolyte balance, and chest radiography. The specific doses of furosemide and the use of additional agents to manage ADHF (dopamine, IV vasodilators, hypertonic saline infusion) were decided based upon blood pressure measurements, renal function evaluation and diuresis response. Supplementary treatment was left to the discretion of the treating physician. The duration of infusion was continued for up to 72 h, at 48 h the physicians had the possibility to adjust diuretic dose administration on the basis of the clinical response. After 72 h the treatment could be stopped or continued for an additional 36-48 h depending on the patient's condition and diuresis response. Acute kidney injury (AKI) was defined following the RIFLE criteria.

Abbreviations:

(AKI) Acute kidney injury (ADHF) Acute decompensated heart failure (BNP) B-type natriuretic peptide (CHD) Coronary heart disease (cIV) Continuous infusion (iIV) Intermittent infusione (eGFR)Estimated glomerular filtration rate (Hb) Hemoglobin (HF) Heart failure (Hct) Hematocrit (LVEF) Left ventricular ejection fraction (RBC) Red blood cells

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients took part in the random sample selection if they met the diagnostic criteria for acute decompensated HF.
  • Patients with primary diagnosis of ADHF, volume overload with cardia dilation and LVEF <50%, and had BNP levels >100 pg/ml.

排除标准

  • Patients were excluded if they had received more than 2 IV doses of furosemide or any continuous infusion of furosemide 1 month before randomization
  • If they had end-stage renal disease or the need for renal replacement therapy, isolated diastolic dysfunction.
  • Recent myocardial infarction

研究组 & 干预措施

Continuous furosemide infusion

Experimental

The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients;

干预措施: furosemide infusion (Drug)

Intermittent furosemide infusion

Experimental

The group that received the bolus infusion of furosemide (iIV), consisted of 27 patients

干预措施: furosemide infusion (Drug)

结局指标

主要结局

Evaluation of Mean Urine Output Volume During the Infusion Period

时间窗: time period ranging from 72 h to 120 h.

this study aimed to evaluate the effects of continuous infusion of furosemide in comparison to twice daily regimens at similar doses with respect to changes in renal function in terms of creatinine levels and GFR, urine output and BNP levels from admission to discharge

Evaluation of Renal Function in Terms of Creatinine Levels at Discharge

时间窗: from admission to discharge, an average of 12 days

Evaluation of Renal Function in Terms of Changes in Creatinine Levels

时间窗: participants were followed for the duration of hospital stay, an average of 13 days

evaluation of renal function in terms of changes in creatinine levels during hospitalization in the two arms.

Evaluation of B-type Natriuretic Peptide (BNP) Levels From Admission to the End of Treatment

时间窗: from admission to discharge, an average of 12 days

Change in Brain Natriuretic Peptide (BNP) Levels From Admission to the Discharge

时间窗: participants were followed for the duration of hospital stay, an average of 13 days

Evaluation of Renal Function in Terms of Changes in GFR

时间窗: from admission to discharge, an average of 12 days

Evaluation of Renal Function in Terms of GFR Values at Discharge

时间窗: from admission to discharge, an average of 12 days

次要结局

  • Dopamine Infusion During Hospitalization(in-hospital)
  • Length of Hospitalization in the Two Groups(in-hospital)

研究者

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

Alberto Palazzuoli MD PhD

Consultant cardiologist

University of Siena

研究点 (1)

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