Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05030480 |
| Other study ID # |
H-2020-206 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 11, 2020 |
| Est. completion date |
August 18, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Zagazig University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
