- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05030480
Chronic Kidney Disease Among Hypertensive Patients in Ha'il, Saudi Arabia (CKD)
August 25, 2021 updated by: Mohamed E Ghoniem, Zagazig University
Prevalence of Chronic Kidney Disease and Associated Risk Factors Among Hypertensive Non-diabetic Patients in Ha'il Region, Saudi Arabia: A Cross-Sectional Study
Chronic kidney disease (CKD) is defined as persistent abnormalities of kidney structure or function for more than 3 months leading to a sustained reduction in glomerular filtration rate (GFR) and/or to the occurrence of kidney damage markers, such as albuminuria.
[1] CKD is an emerging global public health problem, having significant morbidity and mortality costs on society.
It is considered as an important component of the epidemic of non-communicable diseases in developed, as well as low-income/middle-income countries.
[2] In the Kingdom of Saudi Arabia, CKD has been established as a major health issue in recent decades due to the growing incidence and prevalence of end stage kidney disease (ESKD) among the Saudi population.
The overall prevalence of CKD was 5.7% in 2010.
[3] In 2017, there were around two million cases of CKD and 3818 deaths due to CKD in Saudi Arabia in 2017.
[4] A recent study also reported the overall prevalence of CKD stages 3 to 5 was 4.4% among the Saudi population.
[5] The major consequences of CKD include disease progression and, subsequently, increased risk of cardiovascular disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A cross-sectional study, enrolled 607 Saudi patients, of both sexes, registered for Ha'il University Medical Polyclinic, Ha'il city, Saudi Arabia, from October 6, 2020 to January 31, 2021.
Patients eligible for inclusion in this study included those who were aged 18 years or older and were diagnosed with hypertension.
Hypertension is defined as a systolic blood pressure (SBP) of 140 mm Hg or more, or a diastolic blood pressure (DBP) of 90 mm Hg or more, or taking antihypertensive medication or a positive self-reported history of hypertension (based on a response to the questions "have you ever been told you have high blood pressure" or "a past history of high blood pressure").[13]
Exclusion criteria included pregnant or breastfeeding females; history of nephrotoxic drugs use and any case with known cause of CKD other than hypertension such as diabetes mellitus, polycystic kidney disease, obstructive uropathy or autoimmune diseases.
Among 607 hypertensive patients who underwent health examinations, 175 patients met the exclusion criteria and were removed from the study.
We also removed 40 patients from the remaining 432 individuals due to missing data, leaving 392 patients for analysis.Minimum sample required for this study was calculated using the formula: n = z2 [P (1 - P)/(D2)], confidence level at 95 % (z = 1.96), margin of error (D) is set at 0.05, and (P) is the prevalence of hypertension in adult Saudi population set as 25.5 %. (n = 292).
Data was collected through an interview questionnaire.
The questionnaire included sociodemographic variables (age, sex, height, weight, BMI and smoking habit), hypertension (duration and drugs taken), as well as other chronic comorbidities in addition to previous family history of renal diseases.
This is in addition to the laboratory investigations and radiological reports collected from the participants during the interview.
Study Type
Observational
Enrollment (Actual)
392
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ha'il, Saudi Arabia, 2440
- University of Ha'il
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
A cross-sectional study, enrolled 607 Saudi patients, of both sexes, registered for Ha'il University Medical Polyclinic, Ha'il city, Saudi Arabia, from October 6, 2020 to January 31, 2021.
Patients eligible for inclusion in this study included those who were aged 18 years or older and were diagnosed with hypertension.
Description
Inclusion Criteria:
- Patients eligible for inclusion in this study included those who were aged 18 years or older and were diagnosed with hypertension
Exclusion Criteria:
- pregnant or breastfeeding females; history of nephrotoxic drugs use and any case with known cause of CKD other than hypertension such as diabetes mellitus, polycystic kidney disease, obstructive uropathy or autoimmune diseases.
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
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Chronic kidney disease
eGFR values of less than 60 mL/min/1.73
m2
|
urea, creatinine, GFR
|
Non-Chronic kidney disease
eGFR values more than 60 mL/min/1.73
m2
|
urea, creatinine, GFR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PREVALANCE AND REISK FACTORS
Time Frame: 3 MONTHS
|
Prevalence of Chronic Kidney Disease and Associated Risk Factors among hypertensive non-diabetic patients
|
3 MONTHS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
May 11, 2020
Primary Completion (Actual)
January 18, 2021
Study Completion (Actual)
August 18, 2021
Study Registration Dates
First Submitted
August 20, 2021
First Submitted That Met QC Criteria
August 25, 2021
First Posted (Actual)
September 1, 2021
Study Record Updates
Last Update Posted (Actual)
September 1, 2021
Last Update Submitted That Met QC Criteria
August 25, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-2020-206
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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