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There is no easily applicable method to determine extra cellular volume and consequently estimate DW. Thus DW has to be clinically defined by ''trial and error'' and several indirect methods.
Recently, devices to measure DW by Bioimpedance spectroscopy (BİS) have become available. This non-invasive, cheap easily repeatable method has the potential to improve dialysis outcome in the majority of patients all over the world, The aim of the present project is to assess the feasibility of volume control by using a BİS device.
The excessive mortality of dialysis patients, particularly from cardiovascular events, is undoubtedly related for a large part to hypertension and cardiac damage(1). Most studies reveal that hypertension persists despite antihypertensive drugs. Some authors (Parfrey) have used the term ''natural history'' of heart disease in dialysis, suggesting that deterioration is inevitably linked to that procedure (2).
In sharp contrast, other studies (Charra, Özkahya)(3,4) have shown that a strict volume control strategy decreases blood pressure (BP) without drugs, and prolongs survival. This suggests that volume control is insufficient in most dialysis centers, despite the fact that treating physicians may consider that ''Dry Weight'' (DW) of their patients has been reached. In fact, there is no easily applicable method to determine extra cellular volume and consequently estimate DW. Thus DW has to be clinically defined by ''trial and error'' and several indirect methods.
Recently, devices to measure DW by Bioimpedance spectroscopy (BİS) have become available. This non-invasive, cheap easily repeatable method has the potential to improve dialysis outcome in the majority of patients all over the world, The aim of the present project is to assess the feasibility of volume control by using a BİS device and compare the results with the conventional ways of treatment.
Conventional ways to estimate DW (5)Intradialytic hypotension continues to be a leading problem, especially in the elderly and cardiovascularly compromised patient. This predominance can be explained by the fact that structural and functional abnormalities of the heart and blood vessels increase the sensitivity of the patient to changes in fluid status. It does not only cause discomfort, but also increases mortality. In a recent study, a low post-dialytic blood pressure was associated with a significantly increased risk for mortality . Therefore prevention of intradialytic hypotension, remains an important challenge to the dialysis physician.
The occurrence of hypotension during ultrafiltration (UF) necessitates termination of the UF procedure and is commonly considered as a sign that DW has been reached. However, although intradialytic hypotension is commonly considered to be a sign of hypovolemia, this is not always correct, because too rapid removal of large amounts of fluid within a few hours causes a temporary state of disequilibrium. It has been shown that achievement of DW by volume control in fact decreases the number of hypotensive episodes (5) Therefore, there is a need for objective methods to estimate the body fluid volumesThis prospective, randomized, controlled study aims to evaluate the usefulness of the new BCM device as a method to improve volume control dialysis patients and compare the results with those obtained by conventional volume control modalities. To our knowledge such an investigation has not been done elsewhere.
The investigators believe that the proposed study will produce powerful evidence to convince the nephrological society of the need for strict volume control strategy by using new device BCM in hemodialysis patients. The expected data may change routine practice causing achievement of normal blood pressure level without using anti-hypertensive medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | "Overhydration (OH) in liters" will be estimated with the BCM (Body Composition Monitor, Fresenius Medical Care, Deutschland GmbH) in order to determine dry weight as needed before a dialysis session.
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| Group 2 | No Intervention | BCM results obtained at the beginning 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dry weight adjustment | Device | Dry weight adjustment according to BCM results |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of hypervolemia confirmed by non-invasive bioimpedance spectroscopy technique | within 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of normal blood pressure level without using anti-hypertensive medication | Achievement of normal blood pressure level without using anti-hypertensive medication Changes in post-dialysis body weight Hematocrit and related rHu-EPO doses Serum levels of albumin and Hs-CRP | within 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ender Hur, MD | Contact | 00903722612223 | hurender@hotmail.com | |
| Gursel Yildiz, MD | Contact | 00905055422909 | drgursel@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Ender Hur, M.D | ZKU Nephrology Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Devrek Devlet Hastanesi | Recruiting | Zonguldak | Devrek | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7838273 | Result | Akcicek F, Dilber S, Ozgen G, Ok E, Akalin E, Atabay G, Basci A, Guclu A, Dorhout Mees EJ. Spontaneous perirenal hematoma due to periarteritis nodosa. Nephron. 1994;68(3):396. doi: 10.1159/000188413. No abstract available. | |
| 8066803 | Result | Coker A, Ok E, Tokat Y, Hoscoskun C, Kaplan H, Yararbas O. Evaluation of patients transplanted in countries other than Turkey. Transplant Proc. 1994 Aug;26(4):2455-6. No abstract available. |
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| Ereğli Devlet Hastanesi Diyaliz Merkezi | Recruiting | Zonguldak | Ereğli | Turkey (Türkiye) |
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| Ereğlı Burcu Koç Diyaliz Merkezi | Recruiting | Zonguldak | Ereğli | Turkey (Türkiye) |
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| Ereğlı Can Diyaliz Merkezi | Recruiting | Zonguldak | Ereğli | Turkey (Türkiye) |
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| Atatürk Devlet Hastanesi Diyaliz Merkezi | Recruiting | Zonguldak | Turkey (Türkiye) |
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| Devrek Can Diyaliz Merkezi | Recruiting | Zonguldak | Turkey (Türkiye) |
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| ZKU Uygulama ve Arş Hastanesi Diyaliz Merkezi | Recruiting | Zonguldak | Turkey (Türkiye) |
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| Zonguldak Can Diyaliz Merkezi | Recruiting | Zonguldak | Turkey (Türkiye) |
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| Çaycuma Devlet Hastanesi Diyaliz Merkezi | Recruiting | Zonguldak | Turkey (Türkiye) |
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| Çaycuma Can Diyaliz Merkezi | Recruiting | Zonguldak | Çaycuma | Turkey (Türkiye) |
|
| 7778179 | Result | Ok E, Akcicek F, Toz H, Kursat S, Tobu M, Basci A, Mees EJ. Comparison of the effects of enalapril and theophylline on polycythemia after renal transplantation. Transplantation. 1995 Jun 15;59(11):1623-6. |
| 7792041 | Result | Ok E, Akcicek F, Coker A, Tombuloglu M, Toz H, Tokat Y, Cirit M, Tobu M, Onder G, Basci A. Alloimmune haemolytic anaemia after renal transplantation. Nephrol Dial Transplant. 1995;10(3):404-5. No abstract available. |
| 8643182 | Result | Ok E, Akcicek F, Dorhout Mees EJ, Basci A, Mir S, Kursat S, Unsal A. Malignant hypertension in a haemodialysis patient treated by ultrafiltration. Nephrol Dial Transplant. 1995 Nov;10(11):2124-5. No abstract available. |