Bioimpedance and Hand-held Echocardiographay for Clinical Decision-making in Treatment of Cardio-renal Syndrome Type I

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cardio-Renal Syndrome
• Intervention / Treatment: Other: Providing caring physicians with hemodynamic variables

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hemodynamic data available; Providing caring physicians with hemodynamic variables measured using the NICAS system.	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.
No Intervention: Hemodynamic data not available; Hemodynamic variables measured using the NICAS system will not be provided to the caring physicians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel
• Investigators: Principal Investigator: Guy Dori, MD, DSc, Haemek Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): June 16, 2019
• Study Completion (Actual): June 16, 2019

Study Registration Dates

• First Submitted: November 7, 2016
• First Submitted That Met QC Criteria: November 8, 2016
• First Posted (Estimate): November 9, 2016

Study Record Updates

• Last Update Posted (Actual): June 28, 2019
• Last Update Submitted That Met QC Criteria: June 26, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Disease; Renal Insufficiency; Heart Failure; Syndrome; Cardio-Renal Syndrome
• Other Study ID Numbers: EMC-0081-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Investigators do not plan to share the IPD with any body. After completion of study we plan to publish results.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No