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

NCT02959281 | Withdrawn

• 1 other identifier: EMC-0081-16
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardio-Renal Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time from maximum serum creatinine level to patient's discharge

  2 months

• Maximum difference in serum creatinine level

  2 months

Study Arms (2)

Hemodynamic data available

EXPERIMENTAL

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

Other: Providing caring physicians with hemodynamic variables

Hemodynamic data not available

NO INTERVENTION

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

Interventions

Providing caring physicians with hemodynamic variables 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 available

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Related 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.

  PMID: 22840531 BACKGROUND

MeSH Terms

Conditions

Cardio-Renal Syndrome

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Guy Dori, MD, DSc

  haemek medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Internal Medicine E

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 9, 2016
• Study Start: June 1, 2018
• Primary Completion: June 16, 2019
• Study Completion: June 16, 2019
• Last Updated: June 28, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share