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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03905122
Other study ID # TUTF-BAEK 2018/229
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 15, 2018
Est. completion date June 15, 2020

Study information

Verified date October 2020
Source Trakya University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Dialysis methods applied at the bedside and dialysis methods applied in hemodialysis unit are widely applied in patients with renal insufficiency. Especially hemodynamically affected patients are less affected by hemodynamics as a result of using dialysis methods. It is a completely non-invasive method by bioreactance method and it can be done to measure the intra-body fluid status with the help of the glued probes. The aim of this study is to investigate the effects of continuous venous dialysis and hemodialysis on the fluid dynamics applied at the bedside with bioreactance method. In this way, the patient can develop more comfortable hemodynamic changes. Patients in the Surgery, Reanimation and Postoperative Intensive Care Unit with more than 24 hours of hospitalization and bedside dialysis or hemodialysis will be included in the study. Before the dialysis, body fluid measurements will be made with bioreactance, and after dialysis in patients receiving hemodialysis, and in dialysis patients 6, 12, 24 and 36 hours.


Description:

Dialysis methods applied at the bedside and dialysis methods applied in hemodialysis unit are widely applied in patients with renal insufficiency. Especially hemodynamically affected patients are less affected by hemodynamics as a result of using dialysis methods. Dialysis in the hemodialysis unit is a method used in intensive care patients and is preferred especially in patients with stable hemodynamics. In dialysis methods, changes occur frequently in the body fluids of the patient. It is a completely non-invasive method by bioreactance method and it can be done to measure the intra-body fluid status with the help of the glued probes. The aim of this study is to investigate the effects of continuous venous dialysis and hemodialysis on the fluid dynamics applied at the bedside with bioreactance method. As a result of measurements with buioreactans method, fluid balance in patients will be understood more easily. In this way, the patient can develop more comfortable hemodynamic changes. Patients in the Surgery, Reanimation and Postoperative Intensive Care Unit with more than 24 hours of hospitalization and bedside dialysis or hemodialysis will be included in the study. Before the dialysis, body fluid measurements will be made with bioreactance, and after dialysis in patients receiving hemodialysis, and in dialysis patients 6, 12, 24 and 36 hours.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 15, 2020
Est. primary completion date June 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- patients required dialysis therapy

Exclusion Criteria:

- under 18 years old

- confirmed or undiagnosed brain death

Study Design


Related Conditions & MeSH terms


Intervention

Device:
bioreactans tool
It is a completely non-invasive method by bioreactance method and it can be done to measure the intra-body fluid status with the help of the probes.

Locations

Country Name City State
Turkey Trakya University Edirne

Sponsors (1)

Lead Sponsor Collaborator
Trakya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in thoracic fluid content change in thoracic fluid content before and after hemodialysis therapy, before bedside continous venovenous dialysis therapy and 6,12,24 and 36. hours
Primary change in Cardiac Output change in Cardiac Output before and after hemodialysis therapy, before bedside continous venovenous dialysis therapy and 6,12,24 and 36. hours
Primary change in Cardiac Index change in Cardiac Index before and after hemodialysis therapy, before bedside continous venovenous dialysis therapy and 6,12,24 and 36. hours
Primary change in stroke volum change in stroke volum before and after hemodialysis therapy, before bedside continous venovenous dialysis therapy and 6,12,24 and 36. hours
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