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| Name | Class |
|---|---|
| Fresenius Medical Care North America | INDUSTRY |
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This prospective, randomized, controlled study aims to evaluate the usefulness of the new body composition monitor (BCM) device as a method to improve volume control in hemodialysis (HD) patients and compare the results with those obtained by conventional volume control modalities.
The proposed prospective, randomized, controlled study intends to document the effect of volume control guided by BCM on blood pressure (determined both manually and 48-h ambulatory), need for anti-hypertensive medication, intra-dialytic complications, and left ventricular geometry and functions assessed by echocardiography. One hundred and seventy-six prevalent HD patients will be randomized into two arms: study group and control group.
In the study group, "overhydration (OH) in liters" will be estimated with the BCM (Body Composition Monitor, Fresenius Medical Care, Deutschland GmbH)at least once a month before a dialysis session in order to determine dry weight.
If OH is positive value, we will try to reach dry weight by ultrafiltration without regard to the level of blood pressure.
If OH is negative value , and:
If the CT is negative we will repeat the BCM measurement and if it gives same results we will perform ABPM for confirmation.
We will not need to reach the dry weight immediately. If severe BP drop precludes reaching DW in one session, an isolated ultrafiltration or additional dialysis session will be added.
In the control group, BCM results obtained at the beginning, at the 6th, and 12th months will not be given to the treating physicians. Dry weight estimation will be guided by clinical findings, telecardiography, and echocardiography as used to be.
The planned duration of the study is 12 months. All patients will be seen in every month during the study. Additional visits will be scheduled if any symptoms and intolerance are suspected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Active Comparator | Pre-dialytic overhydration(OH) will be estimated by Body Composition Monitor (BCM) at least once a month.
If CT is negative, BCM measurement will be repeated and if same,ABPM will be performed for confirmation. |
|
| Control Group | Other | BCM results obtained at the beginning, at the 6th, and 12th months will not be given to the treating physicians. Dry weight estimation will be guided by clinical findings, telecardiography, and echocardiography as used to be. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCM | Device | Overhydration (OH) in liters will be estimated with the BCM (Body Composition Monitor, Fresenius Medical Care, Deutschland GmbH) in order to determine dry weight at least once a month before a dialysis session. |
| Measure | Description | Time Frame |
|---|---|---|
| Regression of left ventricular mass index (LVMI) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in post-dialysis body weight | 1 year | |
| Achievement of normal blood pressure level without using anti-hypertensive medication | 1 year | |
| Decrease in left atrial volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ercan Ok, MD | Ege University Division of Nephrology | Study Director |
| Gulay Asci, MD | Ege University Division of Nephrology | Principal Investigator |
| Ender Hur, MD | Ege University Division of Nephrology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ege University Division of Nephrology | Bornova | İzmir | 35100 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D017379 | Hypertrophy, Left Ventricular |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006984 | Hypertrophy |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| control group | Other | BCM results obtained at the beginning, at the 6th, and 12th months will not be given to the treating physicians. Dry weight estimation will be guided by clinical findings, telecardiography, and echocardiography as used to be. |
|
| 1 year |
| Hematocrit and related rHu-EPO doses | 1 year |
| Serum levels of albumin and Hs-CRP | 1 year |
| Plasma level of pro-BNP | 1 year |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008722 | Methods |