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临床试验/NCT02959281
NCT02959281撤回不适用

The Application of Bio-impedance System NICAS and Hand-held Echocardiographic System (VSCAN) as Tools for Clinical Decision-making in the Treatment of In-patients With Cardio-renal Syndrome Type I

HaEmek Medical Center, Israel0 个研究点开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Mean hospitalization duration (in days)

研究概览

简要总结

The purpose of this study is to investigate whether hemodynamic data obtained by a noninvasive bio-impedance system (NICAS) sampled from patients with cardiorenal syndrome type I (CRS1) improve clinical outcomes. We hypothesize that hemodynamic data provided to the caring physician will improve management of CRS1 patients.

详细描述

Patients admitted to the hospital due to acute decompensation of heart failure (ADHF) may manifest some deterioration in their renal function. The latter is associated with unfavorable outcomes: prolonged hospitalization and death. Cardiorenal syndrome type 1 (CRS1) is defined as a deterioration in renal function manifested by an increase in serum creatinine level by >0.3 mg% compared to patient's baseline level. The etiology of CRS1 is not clear and may be related to body fluid overload congesting the kidneys or dehydration reducing perfusion to the kidneys. Body fluid status is affected by diuretics. Presently, the practitioner has no objective data to assess whether CRS1 resulted from fluid overload or dehydration.

In this study investigators plan to measure hemodynamic parameters from all patients admitted with CRS1 to our department. Parameters will be measured using the noninvasive bio-impedance system (NICAS). Randomly, patients will be allocated to either a study or control group. In the study group, the hemodynamic variables of the NICAS system will be available to the caring physicians. The physicians will use the data according to their discretion. The hemodynamic system is a decision making supporting system and therefore the physician may use the data according to his/her understanding. In the control group, the hemodynamic variables of the NICAS system will not be available to the caring physicians.

We hypothesize that using the NICAS system as a decision making supporting system will improve patient management by decreasing length of hospitalization, and shortening the time interval to reverse creatinine to its baseline level.

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
Single (Participant)

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient admitted for acute decompensation of heart failure and developed cardiorenal syndrome (all three criteria below are required):
  • A. Evidence of heart failure defined by either (i) or (ii) and (iii), where:
  • (i) is clinical complaints of dyspnea or leg swelling or fatigue (ii) is clinical findings of pulmonary rales, leg edema, or congestion on chest film (iii) is recent (within 1 year of admission) echocardiographic examination demonstrating heart failure B. Patient as in A (above) whos serum creatinine level on admission is 0.3 mg% greater than patient's baseline.
  • C. Patient capable of submitting informed consent

排除标准

  • Other causes for dyspnea or leg edema (e.g. exacerbation of COPD, pneumonia, liver cirrhosis, hypoalbuminemia, nephrotic syndrome)
  • other causes for acute renal failure (e.g. contrast media nephropathy 10 days prior to admission, use of NSAIDS or antibiotics (aminoglycosides, quinolones), diarrhea, vomiting, rhabdomyolysis, seizures, sepsis.
  • Anemia (Hb<8 gr%)
  • significant bleeding (upper or lower GI, hemoptysis)
  • BMI>40, or BMI<18
  • Signs of a new myocardial infarction by EKG, and increase in troponin levels to levels 1.5 above baseline levels.
  • Hypothyroidism
  • Addison's disease
  • patient on Hemo- or peritoneal dialysis
  • Mechanical ventillation

研究组 & 干预措施

Hemodynamic data available

Experimental

Providing caring physicians with hemodynamic variables measured using the NICAS system.

干预措施: Providing caring physicians with hemodynamic variables (Other)

Hemodynamic data not available

No Intervention

Hemodynamic variables measured using the NICAS system will not be provided to the caring physicians.

结局指标

主要结局

Mean hospitalization duration (in days)

时间窗: 2 months

Time of hospitalization is defined from time of recruitment till the time patient is ready for discharge.

次要结局

  • Time from maximum serum creatinine level to patient's discharge(2 months)
  • Maximum difference in serum creatinine level(2 months)

研究者

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

Guy Dori

Head, Internal Medicine E

HaEmek Medical Center, Israel

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