Hypertension Clinical Trial
Official title:
CKD Prevalence and the Role of Cardiovascular Risk Factors and Infectious Diseases in a Region of Sub-Saharan Africa
Prospective cross-sectional study at the outpatient clinic (OPC) of the Bagamoyo District
Hospital (BDH) in Tanzania. Assessment of basic epidemiological data (Point prevalence and
risk factors) on CKD with simple clinical, laboratory tests and the patients history. After
informed consent blood samples are taken for complete blood count, serum creatinine, HbA1c,
HIV-Screening, and urine samples for dipstick, urine sediment, and albumin-creatinine ratio.
Further, office blood pressure, weight and height are taken. Further, patients history are
asked by a questionnaire (i.e.history of infectious and cardiovascular diseases and basic
demographic data: i.e. sex, age).
CKD is defined as the presence of either impaired kidney function and/or albuminuria based on
a one-time measurement.
Primary outcome of the study are prevalence rates of CKD and the impact of non-communicable
and communicable disorders on CKD.
Study population and Setting:
Single centre cross-sectional study at the outpatient clinic (OPC) of the Bagamoyo District
Hospital (BDH) in Tanzania. The BDH is located in Bagamoyo township on the coast of the
Indian Ocean and provides care for a semi-rural population. After informed consent, all
patients ≥ 18 years, irrespective of the reason of consultation, are included. Pregnant women
and patients who are not able or willing to provide an informed signed consent are excluded.
Measurements and procedures:
All data are collected in a case report form, translated from English to Swahili. In all
participants body weight and height, blood pressure, heart rate and temperature are recorded.
After informed consent, a blood sample is taken for complete blood count and serum
creatinine. Complete blood count is performed by a Sysmex Xs 800i analyser. Serum creatinine
is measured using Creatinine Jaffe Gen2 reagent on a Cobas Integra 400 plus analyser. HbA1c
is measured from capillary blood by using a bed-side DCA 2000+ Analyzer (Siemens Healthcare
Diagnostics). After informed consent, HIV-screening is done with an immunochromatographic
test for antibodies to HIV-1 and HIV-2 (test kits: Uni-Gold TM HIV, Trinity Biotech, Ireland;
Determine® HIV-1/2, Inverness Medical Japan, Japan; SD BIOLINE HIV-1/2 3.0, SD Standard
Diagnostics, Korea).
All participants are instructed to void a clean-urine specimen. Urine samples are prepared
for microscopic analysis. Albumin-to- creatinine ratio (ACR) is measured using a DCA 2000+
analyser (Siemens Healthcare Diagnostics). CKD is defined as the presence of either impaired
kidney function and/or albuminuria based on a one-time measurement. When one-time
measurements are used, prevalence of reduced glomerular filtration rate (GFR) and albuminuria
might be overestimated due to physiological variation and temporarily elevated values after
physical activity and during acute illness or dehydration. Nevertheless, one-time
measurements have been used for screening and epidemiologic purposes, as longitudinal
documentation is not usually available in epidemiological studies. Kidney function is
assessed by eGFR using the CKD-EPI formula. CKD is defined as an eGFR of <60 ml/min/1.73m2
and/or an ACR of ≥30mg/g (≥3 mg/mmol) and categorized according to Kidney Disease: Improving
Global Outcomes (KDIGO) stages. Office BP is assessed by a single measurement using a manual
sphygmomanometer in a sitting position after 5 minutes at rest. Systolic and diastolic BP is
classified as normal (<120/<80 mmHg), pre-hypertensive (120-139/80-89 mmHg), hypertensive
stage 1 (140-159/90-99 mmHg) or hypertensive stage 2 (≥160/≥100 mmHg) in analogy to the
cut-off values of the JNC 7 report. Anaemia is defined as Hb <13.0 g/dl in male and <12.0
g/dl in female patients. Diabetes mellitus is defined as a history of diabetes, the use of
antidiabetic medication or a HbA1c of ≥ 6.5%.
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