Chronic Kidney Disease Among Hypertensive Patients in Ha'il, Saudi Arabia

NCT ID: NCT05030480

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 392 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-11
• Study Completion Date: 2021-08-18

Brief Summary

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.

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.

Conditions

Chronic Kidney Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Chronic kidney disease

eGFR values of less than 60 mL/min/1.73 m2

renal functions

Intervention Type: DIAGNOSTIC_TEST

urea, creatinine, GFR

Non-Chronic kidney disease

eGFR values more than 60 mL/min/1.73 m2

renal functions

Intervention Type: DIAGNOSTIC_TEST

urea, creatinine, GFR

Interventions

renal functions

urea, creatinine, GFR

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mohamed E Ghoniem

Associate Professor of Internal Medicine- Faculty of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Ha'il

Ha'il, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

H-2020-206

Identifier Type: -

Identifier Source: org_study_id