Impact of Residual Renal Function on Complications in Chronic Hemodialysis Patients

February 25, 2019 updated by: Abdelrahman Hassan Mohyeldein, Assiut University
Our aim is to study the impact of residual renal function on hemodialysis patients mortality and morbidity .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

any populatin

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Mohammed A. Sobh, Assuit Univeristy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 26, 2019

Primary Completion (Anticipated)

February 15, 2020

Study Completion (Anticipated)

April 20, 2020

Study Registration Dates

First Submitted

February 14, 2019

First Submitted That Met QC Criteria

February 25, 2019

First Posted (Actual)

February 26, 2019

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Impact of HD on Kidneys

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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