Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02959281
Other study ID # EMC-0081-16
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date June 16, 2019

Study information

Verified date June 2019
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 16, 2019
Est. primary completion date June 16, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 90 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Providing caring physicians with hemodynamic variables
NICAS electrodes are applied to the skin of the forearm bilaterally (similar to EKG electrodes). Conductors, attached to the electrodes, connect the patient with the measuring system.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
HaEmek Medical Center, Israel

References & Publications (1)

Ronco C, Cicoira M, McCullough PA. Cardiorenal syndrome type 1: pathophysiological crosstalk leading to combined heart and kidney dysfunction in the setting of acutely decompensated heart failure. J Am Coll Cardiol. 2012 Sep 18;60(12):1031-42. doi: 10.1016/j.jacc.2012.01.077. Epub 2012 Jul 25. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mean hospitalization duration (in days) Time of hospitalization is defined from time of recruitment till the time patient is ready for discharge. 2 months
Secondary Time from maximum serum creatinine level to patient's discharge Time from maximum serum creatinine level to time when patient is ready for discharge 2 months
Secondary Maximum difference in serum creatinine level This outcome is defined by the maximum serum creatinine level obtained during the followup of the patient minus patient's mean serum creatinine level 2 months
See also
  Status Clinical Trial Phase
Recruiting NCT05053893 - Roxadustat Combined With Sacubitril Valsartan Sodium Tablets in the Treatment of Cardiorenal Anemia Syndrome N/A
Recruiting NCT03176862 - Left Ventricular Fibrosis in Chronic Kidney Disease N/A
Recruiting NCT04170855 - Kidney Sodium Content in Cardiorenal Patients N/A
Not yet recruiting NCT05079724 - Acute Kidney Injury After Cardiac Surgery
Withdrawn NCT02085668 - Renal Denervation in Patients With Chronic Heart Failure N/A
Terminated NCT02772146 - A Clinical Study of the Safety and Efficacy of a Wearable Device (CLS UF) That Delivers Continuous Administration of Glucose to Recirculated Peritoneal Dialysis Fluid for the Purpose of Ultrafiltration in Patients With Congestive Heart Failure N/A
Recruiting NCT02846337 - Ultrafiltration Versus Medical Therapies in the Management of the Cardio Renal Syndrome N/A
Active, not recruiting NCT02502981 - Comparing the Effects of Spironolactone With Chlortalidone on LV Mass in Patients With CKD Phase 4
Recruiting NCT04947670 - A Prospective, Multicenter, Randomized, Blinded, Sham-controlled, Feasibility Study of Renal Denervation in Patients With Chronic Heart Failure N/A
Not yet recruiting NCT05368766 - Predictive Value of Venous Excess Ultrasound Score in Management of Cardiorenal Patients
Completed NCT04407936 - Risk Factors and Prognosis of Adverse Cardiovascular and Kidney Events After Coronary Intervention
Completed NCT05050877 - Risk Factors and Prognosis of Adverse Cardiovascular and Kidney Events After Coronary Intervention II
Recruiting NCT03628443 - Cardiorenal Risk Stratification Pilot Study
Recruiting NCT02343393 - Nitrates In Combination With Hydralazine in cardiorEnal Syndrome (NICHE) Study Phase 3
Completed NCT02664246 - Contrast-induced Nephropathy: Incidence,Risk Factors,Effective Prevention and Management Method N/A
Completed NCT03219996 - Risk Factors for Predictors of In-hospital Death in Acute Fulminant Myocarditis N/A
Completed NCT04145635 - The Aortix CRS Pilot Study N/A
Completed NCT02405377 - Central Venous Pressure Guided Hydration Prevention for Contrast-Induced Nephropathy N/A
Recruiting NCT05677100 - Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure N/A
Completed NCT02831907 - Portal Flow Pulsatility as a Risk Factor for Acute Kidney Injury After Cardiac Surgery N/A