Impact of Residual Renal Function on Complications in Chronic Hemodialysis Patients

Hemodialysis Complication Clinical Trial

Official title:

Impact of Residual Renal Function on Complications in Chronic Hemodialysis Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03854513
• Other study ID #: Impact of HD on Kidneys
• Status: Not yet recruiting
• Start date: February 26, 2019
• Est. completion date: April 20, 2020

Study information

• Verified date: February 2019
• Source: Assiut University
• Contact: Abd el_rahman H. Mohy eldein
• Phone: 0201009749401
• Email: Drabdelrahman.mohyeldein[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Our aim is to study the impact of residual renal function on hemodialysis patients mortality and morbidity .

Description:

Chronic kidney disease (CKD) is a progressive loss in renal function over a period of months or years. As kidney function declines, there is progressive deterioration in mineral homeostasis manifesting as disruption of serum and tissue concentrations of phosphorus and calcium (Ca), as well as changes in circulating levels of hormones such as parathyroid hormone (PTH). These mineral and endocrine functions are critically important in the regulation of both initial bone formation during growth (bone modeling) and bone structure and function during adulthood (bone remodeling) Residual renal function (RRF) plays an important role in maintaining fluid balance, phosphorus control, nutrition, and removal of middle molecular uremic toxins. Decline of RRF also contributes significantly to anemia, inflammation, and malnutrition in patients on dialysis.

Inflammation and activation of acute-phase responses are common in chronic kidney disease patients.

The causes of inflammation in HD patients are multifactorial. Inflammatory reaction may originate from several sources, including graft or fistula infections, bioincompatible dialysis membrane, dialysate, endotoxin exposure, back filtration, chronic infections, and malnutrition. High-sensitivity C-reactive protein (hsCRP) assay is useful for sensitive detection of the inflammatory state.

Residual renal function (RRF) in patients with end-stage renal disease (ESRD) receiving renal replacement therapy is defined as the ability of native kidneys to eliminate water and uremic toxins. In clinical practice, it is considered synonymous with such parameters as daily diuresis and/or glomerular filtration rate (GFR). The optimal method to measure RRF has not been established . RRF remains important even after beginning of dialysis. RRF contributes significantly to the overall health and well-being of patients on dialysis Residual Renal (RRF) plays an important role in maintaining fluid balance, phosphorus control, nutrition, and removal of middle molecular uremic toxins and shows inverse relationships with valvular calcification and cardiac hypertrophy in patients on dialysis.

Decline in RRF also contributes significantly to anemia, inflammation, and malnutrition in patients on dialysis . RRF may allow for a reduction in the duration of hemodialysis (HD) sessions and the need for dietary and fluid restrictions in both patients on peritoneal dialysis (PD) and patients on HD. More importantly, the loss of RRF is a powerful predictor of mortality. Much of RRF is lost during the first 18 months of HD, and appears to depend on the primary cause(s) of kidney failure as well as on other patient-related and treatment-related factors

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 20, 2020
• Est. primary completion date: February 15, 2020
• Gender: Male
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• Chronic renal failure patients on maintenance hemodialysis after at least six months.

Exclusion Criteria:

1. Obstructive uropathy.

2. Heart failure.

3. Chronic liver disease( decompensated liver cirrhosis and ascites).

Related Conditions & MeSH terms

• Hemodialysis Complication

Intervention

Device:
• dialysis machine
A machine used in dialysis that filters a patient's blood to remove excess water and waste products when the kidneys are damaged

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Cho HY, Hyun HS, Kang HG, Ha IS, Cheong HI. Prevalence of 25(OH) vitamin D insufficiency and deficiency in pediatric patients on chronic dialysis. Perit Dial Int. 2013 Jul-Aug;33(4):398-404. doi: 10.3747/pdi.2011.00246. Epub 2012 Dec 3. — View Citation

Hu SL, Joshi P, Kaplan M, Lefkovitz J, Poenariu A, Dworkin LD, Michaud DS. Rapid Change in Residual Renal Function Decline Is Associated with Lower Survival and Worse Residual Renal Function Preservation in Peritoneal Dialysis Patients. Perit Dial Int. 2017 Jul-Aug;37(4):477-481. doi: 10.3747/pdi.2016.00211. — View Citation

Kazmi WH, Gilbertson DT, Obrador GT, Guo H, Pereira BJ, Collins AJ, Kausz AT. Effect of comorbidity on the increased mortality associated with early initiation of dialysis. Am J Kidney Dis. 2005 Nov;46(5):887-96. — View Citation

Maksic D, Colic M, Stankovic-Popovic V, Radojevic M, Bokonjic D. Systemic and intraperitoneal proinflammatory cytokines profiles in patients on chronic peritoneal dialysis. Med Pregl. 2007;60 Suppl 2:53-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determine complications of hemodialysis on patients with chronic kidney disease	impact of residual renal function on hemodialysis patients mortality and morbidity and imprtance of high residual renal function on patients lifespan; - residual renal function will assess by GFR which assess by MDRD and creatinine clearance methods	baseline