Impact of Residual Renal Function on Complications in Chronic Hemodialysis Patients

NCT ID: NCT03854513

Last Updated: 2019-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-26

Study Completion Date

2020-04-20

Brief Summary

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

Detailed Description

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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

Conditions

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Hemodialysis Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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-Group 1 (anuric)

patients on maintenance hemodialysis after 6 months to 1 year or more and urinary output less than 100ml / day

dialysis machine

Intervention Type DEVICE

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

Group 2 (good UOP)

patients on maintenance hemodialysis after 6 months to 1 year or more and urinary output 400ml / day or more

dialysis machine

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Abdelrahman Hassan Mohyeldein

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed A. Sobh

Role: STUDY_DIRECTOR

Assuit Univeristy

Central Contacts

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Abd el_rahman H. Mohy eldein

Role: CONTACT

0201009749401

Mohammed A. SOBH, Prof

Role: CONTACT

0201069272669

References

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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.

Reference Type BACKGROUND
PMID: 28676514 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23209039 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18928158 (View on PubMed)

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. doi: 10.1053/j.ajkd.2005.08.005.

Reference Type BACKGROUND
PMID: 16253729 (View on PubMed)

Other Identifiers

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Impact of HD on Kidneys

Identifier Type: -

Identifier Source: org_study_id

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