Hemodialysis ComplicationNCT03854513
Impact of Residual Renal Function on Complications in Chronic Hemodialysis Patients
An observational study of Hemodialysis Complication, run by Assiut University.
Trial summary
Our aim is to study the impact of residual renal function on hemodialysis patients mortality and morbidity . Read more about this study
- Who is it for?
- Ages 25 to 45 years, men only
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- dialysis machine
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 26 Feb 2019to 20 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Men only
- Adult
Study population: any populatin
Who may be able to join
- Chronic renal failure patients on maintenance hemodialysis after at least six months.
Who cannot join
- Obstructive uropathy.
- Heart failure.
- Chronic liver disease( decompensated liver cirrhosis and ascites).
Trial locations and contacts
No sites are listed yet.
Mohammed A. SOBH, Prof contact
About this study
Our aim is to study the impact of residual renal function on hemodialysis patients mortality and morbidity .
Read the 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
- Conditions
- Hemodialysis Complication
- Being tested
- dialysis machine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dialysis machineDevice
A machine used in dialysis that filters a patient's blood to remove excess water and waste products when the kidneys are damaged
| Study group | Role | What they receive |
|---|---|---|
| -Group 1 (anuric) | patients on maintenance hemodialysis after 6 months to 1 year or more and urinary output less than 100ml / day Receives: Device: dialysis machine | |
| Group 2 (good UOP) | patients on maintenance hemodialysis after 6 months to 1 year or more and urinary output 400ml / day or more Receives: Device: dialysis machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start26 Feb 2019 (estimated)
- Primary completion15 Feb 2020 (estimated)
- Study completion20 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Hassan Mohyeldein, Assiut University
- Investigators
- Mohammed A. Sobh, Study director, Assuit Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854513
- Sponsor's protocol ID
- Impact of HD on Kidneys
- Status last verified
- Feb 2019
- First submitted
- 14 Feb 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28676514Cho 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.
PubMed 23209039Maksic 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.
PubMed 18928158Kazmi 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.
PubMed 16253729
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Residual Renal Function on Complications in Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03854513
- Acronym / sponsor ID
- Impact of HD on Kidneys
- Conditions
- Hemodialysis Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 26 Feb 2019 (estimated)
- Primary completion
- 15 Feb 2020 (estimated)
- Study completion
- 20 Apr 2020 (estimated)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our aim is to study the impact of residual renal function on hemodialysis patients mortality and morbidity .
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| -Group 1 (anuric) | – | Device: dialysis machinepatients on maintenance hemodialysis after 6 months to 1 year or more and urinary output less than 100ml / day |
| Group 2 (good UOP) | – | Device: dialysis machinepatients on maintenance hemodialysis after 6 months to 1 year or more and urinary output 400ml / day or more |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- any populatin
Key inclusion criteria (1 listed)
- Chronic renal failure patients on maintenance hemodialysis after at least six months.
Key exclusion criteria (3 listed)
- Obstructive uropathy.
- Heart failure.
- Chronic liver disease( decompensated liver cirrhosis and ascites).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dialysis machineA machine used in dialysis that filters a patient's blood to remove excess water and waste products when the kidneys are damaged | Device | -Group 1 (anuric), Group 2 (good UOP) |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Background: PubMed 28676514Hu 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.
- Background: PubMed 23209039Cho 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.
- Background: PubMed 18928158Maksic 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.
- Background: PubMed 16253729Kazmi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed A. SOBH, Prof contact
Mohammed A. Sobh study director
Assuit Univeristy
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis Complication, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abd el_rahman H. Mohy eldein (0201009749401, Drabdelrahman.mohyeldein@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determine complications of hemodialysis on patients with chronic kidney disease (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03854513, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.