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Impact of Residual Renal Function on Complications in Chronic Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT03854513
Recruitment Status : Unknown
Verified February 2019 by Abdelrahman Hassan Mohyeldein, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : February 26, 2019
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Abdelrahman Hassan Mohyeldein, Assiut University

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

Condition or disease Intervention/treatment
Hemodialysis Complication Device: dialysis machine

Detailed 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

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Residual Renal Function on Complications in Chronic Hemodialysis Patients
Estimated Study Start Date : February 26, 2019
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : April 20, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
-Group 1 (anuric)
patients on maintenance hemodialysis after 6 months to 1 year or more and urinary output less than 100ml / day
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

Group 2 (good UOP)
patients on maintenance hemodialysis after 6 months to 1 year or more and urinary output 400ml / day or more
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




Primary Outcome Measures :
  1. determine complications of hemodialysis on patients with chronic kidney disease [ Time Frame: baseline ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Sampling Method:   Non-Probability Sample
Study Population
any populatin
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03854513


Contacts
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Contact: Abd el_rahman H. Mohy eldein 0201009749401 Drabdelrahman.mohyeldein@gmail.com
Contact: Mohammed A. SOBH, Prof 0201069272669

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Mohammed A. Sobh Assuit Univeristy
Publications:
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Responsible Party: Abdelrahman Hassan Mohyeldein, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03854513    
Other Study ID Numbers: Impact of HD on Kidneys
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No