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

NCT ID: NCT02959281

Last Updated: 2019-06-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2019-06-16

Brief 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.

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.

Conditions

Cardio-Renal Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hemodynamic data available

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

Group Type: EXPERIMENTAL

Providing caring physicians with hemodynamic variables

Intervention Type: OTHER

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.

Hemodynamic data not available

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

Guy Dori

Head, Internal Medicine E

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guy Dori, MD, DSc

Role: PRINCIPAL_INVESTIGATOR

haemek medical center

References

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.

Reference Type: BACKGROUND

PMID: 22840531 (View on PubMed)

Other Identifiers

EMC-0081-16

Identifier Type: -

Identifier Source: org_study_id