Clinical trial NCT01468363: Hypervolemia in ESRD Patients in Zonguldak (Prospective Study)
Official title: Hypervolemia and Treatment Guided by Bioimpedance in End Stage Renal Disease Patients in Zonguldak (Prospective Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hemodialysis Fluid Allergy
Keywords: Dry weight
Body composition monitor
Hemodialysis
Zonguldak
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2011-11-09
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age older than 18-year,
* Maintenance bicarbonate HD scheduled thrice weekly (12 hours/week),
* Willingness to participate in the study with a written informed consent.

Exclusion Criteria:

* Presence of a cardiac stent, pacemaker or defibrillator ,
* Artificial joints, pin or amputation
* Permanent or temporary catheters (may affect BCM measurement),
* Beeing scheduled for living donor renal transplantation,
* Presence of serious life-limiting co-morbid situations, like malignancy, uncontrollable infection, end-stage cardiac, pulmonary, or hepatic disease,
* Pregnancy or lactating,
* Current use of investigational drugs or participation in an interventional clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial,
* Mental incompetence.

Primary outcomes:
measure: Evidence of hypervolemia confirmed by non-invasive bioimpedance spectroscopy technique
timeFrame: within 1 year
Secondary outcomes:
measure: Achievement of normal blood pressure level without using anti-hypertensive medication
timeFrame: within 1 year
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Devrek Devlet Hastanesi
state: Devrek
city: Zonguldak
country: Turkey
facility: Ereğlı Burcu Koç Diyaliz Merkezi
state: Ereğli
city: Zonguldak
country: Turkey
facility: Ereğlı Can Diyaliz Merkezi
state: Ereğli
city: Zonguldak
country: Turkey
facility: Ereğli Devlet Hastanesi Diyaliz Merkezi
state: Ereğli
city: Zonguldak
country: Turkey
facility: Atatürk Devlet Hastanesi Diyaliz Merkezi
city: Zonguldak
country: Turkey
facility: Devrek Can Diyaliz Merkezi
city: Zonguldak
country: Turkey
facility: ZKU Uygulama ve Arş Hastanesi Diyaliz Merkezi
city: Zonguldak
country: Turkey
facility: Zonguldak Can Diyaliz Merkezi
city: Zonguldak
country: Turkey
facility: Çaycuma Devlet Hastanesi Diyaliz Merkezi
city: Zonguldak
country: Turkey
facility: Çaycuma Can Diyaliz Merkezi
state: Çaycuma
Study officials:
affiliation: ZKU Nephrology Department
name: Ender Hur, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.