NCT02959281

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: HaEmek Medical Center, Israel · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-06-16
• Completion: 2019-06-16
• First posted: 2016-11-09
• Last updated: 2019-06-28