Renal Resistive Index as a Predictor of Renal Involvement in Rheumatoid Arthritis

January 25, 2024 updated by: Fatma Noman Mohamed AbdElaziz, Assiut University

Predictor of Renal Involvement in Rheumatoid Arthritis:Value of Renal Resistive Index

Evaluation of resistive index on the renal artery as early predictor factor of renal affection in patients with rheumatoid arthritis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Rheumatoid arthritis (RA) is a chronic autoimmune disorder characterized by synovial hyperplasia and inflammation, progressive joint destruction, and significant disability (1). It can occur at any age, but it predominantly affects women, with a peak onset between the ages of 40 and 60. RA etiology is not yet clear, Recent studies have shown that its mechanism is closely related to genetics, environment, and immune response. Genes such as MHC and HLA-DR4 are involved in the occurrence of RA. (2) Renal complications in RA can range from mild abnormalities in kidney function to more severe conditions, such as glomerulonephritis and renal amyloidosis. Understanding these renal complications is crucial for healthcare providers to ensure comprehensive care for RA patients. (3.4) Vasculitis is an uncommon complication of RA (in approximately 2 to 5% of patients), males with RA are more likely (2 to 4 times more likely) than females with RA to develop RV. Rheumatoid vasculitis most often occur in people with at least 10 years of severe disease. Fortunately, recent reports have noted declines in the prevalence of RV ( 5.6). So The renal arterial resistive index (RI)which is a sonographic index of intrarenal arteries defined as (peak systolic velocity - end-diastolic velocity) / peak systolic velocity. The normal range is 0.50-0.70. Elevated values are associated with poorer prognosis in various renal disorders .

Study Type

Observational

Enrollment (Estimated)

144

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

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Base on determining the main outcome variable, the estimated minimum required sample size is 144 cases (48 case in each group)

The sample size was calculated using G*power software 3.1.9.7 based on following assumptions:

Mean serum creatinine level in RA patients without renal affection compared to mean serum creatinine level RA patients with renal affection and control group.

The Effect size is estimated to be 0.3. Main statistical test is one way ANOVA ,Alpha=0.05, power=90

Description

Inclusion Criteria:

  • Patients of rheumatoid arthritis è renal affection
  • Patients of rheumatoid arthritis without renal affection
  • Patients of rheumatoid arthritis on drugs (NSAIDs, DMARDS, methotrexate..).

Exclusion Criteria:

  • Diabetic and hypertensive patients, patients with hepatitis B, C viruses or liver cell failure, patients with acute kidney injury, patients with another autoimmune disease as (SLE, sjogren disease, multiple sclerosis, patients with malignancy, patients on another drugs otherwise rheumatoid arthritis drugs).

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 A
will include 48 RA patients without renal affection.
Diagnostic test: KDIGO criteria of 2010
They are guidelines for the diagnosis, evaluation, and management of chronic kidney disease (CKD). They cover the classification of CKD stages based on glomerular filtration rate and albuminuria, criteria for diagnosing acute kidney injury, and recommendations for managing CKD-related complications.
Group B
will include 48 RA patients with renal affection.
Diagnostic test: KDIGO criteria of 2010
They are guidelines for the diagnosis, evaluation, and management of chronic kidney disease (CKD). They cover the classification of CKD stages based on glomerular filtration rate and albuminuria, criteria for diagnosing acute kidney injury, and recommendations for managing CKD-related complications.
Group C
will include 48 healthy control.
Diagnostic test: KDIGO criteria of 2010
They are guidelines for the diagnosis, evaluation, and management of chronic kidney disease (CKD). They cover the classification of CKD stages based on glomerular filtration rate and albuminuria, criteria for diagnosing acute kidney injury, and recommendations for managing CKD-related complications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating predictive value of renal resistive index in detection of rheumatoid arthritis.
Time Frame: baseline
Assesses the predictive utility of renal resistive index in detecting rheumatoid arthritis. Delve into the exploration of whether renal resistive index serves as a reliable marker, offering valuable insights into the potential diagnostic relevance for rheumatoid arthritis.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify the risk factor for renal complication in RA patients
Time Frame: baseline
Explore the factors contributing to renal complications in rheumatoid arthritis (RA) patients with a focus on identifying key risk factors. Uncover insights that enhance our understanding of the complex relationship between RA and renal involvement, ultimately aiding in targeted prevention and management strategies.
baseline

Collaborators and Investigators

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

Sponsor

Assiut University

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 (Estimated)

February 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

January 18, 2024

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Estimated)

January 26, 2024

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PORIIRA

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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