Hypervolemia in ESRD Patients in Zonguldak (Prospective Study)

NCT01468363 | Unknown Phase 4

• 1 other identifier: ZKU 2011-77-21/06
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 10

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.

Conditions

Hemodialysis Fluid Allergy

Keywords

Dry weight; Body composition monitor; Hemodialysis; Zonguldak

Outcome Measures

Primary Outcomes (1)

• Evidence of hypervolemia confirmed by non-invasive bioimpedance spectroscopy technique

  within 1 year

Secondary Outcomes (1)

• Achievement of normal blood pressure level without using anti-hypertensive medication

  within 1 year

Study Arms (2)

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. 1. If OH is positive value, we will try to reach dry weight by ultrafiltration without regard to the level of blood pressure. 2. If OH is negative value , we will not change dry weight.

Device: Dry weight adjustment

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.

Device: Dry weight adjustment

Interventions

Dry weight adjustment DEVICE

Dry weight adjustment according to BCM results

Also known as: Group 1: BCM Adjusted Group, Group 2: Classical Group

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (10)

Devrek Devlet Hastanesi

Zonguldak, Devrek, Turkey (Türkiye)

RECRUITING

Ereğli Devlet Hastanesi Diyaliz Merkezi

Zonguldak, Ereğli, Turkey (Türkiye)

RECRUITING

Ereğlı Burcu Koç Diyaliz Merkezi

Zonguldak, Ereğli, Turkey (Türkiye)

RECRUITING

Ereğlı Can Diyaliz Merkezi

Zonguldak, Ereğli, Turkey (Türkiye)

RECRUITING

Atatürk Devlet Hastanesi Diyaliz Merkezi

Zonguldak, Turkey (Türkiye)

RECRUITING

Devrek Can Diyaliz Merkezi

Zonguldak, Turkey (Türkiye)

RECRUITING

ZKU Uygulama ve Arş Hastanesi Diyaliz Merkezi

Zonguldak, Turkey (Türkiye)

RECRUITING

Zonguldak Can Diyaliz Merkezi

Zonguldak, Turkey (Türkiye)

RECRUITING

Çaycuma Devlet Hastanesi Diyaliz Merkezi

Zonguldak, Turkey (Türkiye)

RECRUITING

Çaycuma Can Diyaliz Merkezi

Zonguldak, Çaycuma, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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.

  PMID: 7838273 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.

  PMID: 8066803 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.

  PMID: 7778179 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.

  PMID: 7792041 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.

  PMID: 8643182 RESULT

Study Officials

• Ender Hur, M.D

  ZKU Nephrology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ender Hur, MD

CONTACT

00903722612223; hurender@hotmail.com

Gursel Yildiz, MD

CONTACT

00905055422909; drgursel@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Specialist, Nephrology Department

Study Record Dates

• First Submitted: November 5, 2011
• First Posted: November 9, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 10, 2011

Record last verified: 2011-11

Locations

TU (10)