NCT03854513

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

February 26, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2020

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

12 months

First QC Date

February 14, 2019

Last Update Submit

February 25, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

-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

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

Interventions

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

-Group 1 (anuric)Group 2 (good UOP)

Eligibility Criteria

Age25 Years - 45 Years
Sexmale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

any populatin

You may qualify if:

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

You may not qualify if:

  • Obstructive uropathy.
  • Heart failure.
  • Chronic liver disease( decompensated liver cirrhosis and ascites).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 28676514BACKGROUND
  • 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.

    PMID: 23209039BACKGROUND
  • 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.

    PMID: 18928158BACKGROUND
  • 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.

    PMID: 16253729BACKGROUND

MeSH Terms

Interventions

Kidneys, Artificial

Intervention Hierarchy (Ancestors)

Artificial OrgansSurgical EquipmentEquipment and Supplies

Study Officials

  • Mohammed A. Sobh

    Assuit Univeristy

    STUDY DIRECTOR

Central Study Contacts

Abd el_rahman H. Mohy eldein

CONTACT

Mohammed A. SOBH, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 26, 2019

Study Start

February 26, 2019

Primary Completion

February 15, 2020

Study Completion

April 20, 2020

Last Updated

February 26, 2019

Record last verified: 2019-02