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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05134220
Other study ID # Electrolytes
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 30, 2021
Est. completion date May 30, 2022

Study information

Verified date November 2021
Source Sohag University
Contact Ahmed M YOUSEF, M.B.B.CH
Phone 01067439846
Email ahmed011032@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Study of serum calcium and phosphorus level in chronic kidney disease patients and its relation to occurrence of acute coronary syndrome in them.


Description:

Prospective study to : 1. find the relation between electrolytes disturbance and renal diseases 2. the effect of electrolyte abnormalities on atherosclerosis 3. prevalence of acute coronary syndrome in patients with chronic kidney disease


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 30, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 1-The CKD patients with or without dialysis who admitted to coronary care unit with chest pain consistent with ACS with any of following features : a- Electrocardiogram (ECG) changes: - ST elevation. - ST depression. - T wave inversion. - recent left bundle branch block. b- Troponin T elevation. 2-The CKD patient with or without dialysis with no previous history of ACS. Exclusion Criteria: 1. Patients who were diagnosed with primary hyperparathyroidism. 2. Acute Kidney injury (AKI) which is defined as any of the following:(KDIGO2012) - Increase in S.Cr by = 0.3 mg/dl (= 26.5 µmol/l) within 48hours; or - Increase in S.Cr to = 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days;or - Urine volume <0.5 ml/kg/h for 6 hours

Study Design


Intervention

Diagnostic Test:
Serum Calcium
Serum calcium level. Serum phosphorus level. will be measured to all study population

Locations

Country Name City State
Egypt Sohag university Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Block GA, Hulbert-Shearon TE, Levin NW, Port FK. Association of serum phosphorus and calcium x phosphate product with mortality risk in chronic hemodialysis patients: a national study. Am J Kidney Dis. 1998 Apr;31(4):607-17. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Chronic kidney disease hospitalization The CKD patient with and without acute coronary syndrome and estimated hazard ratios (HR) by use of multivariable Cox regression models. from the day of admission to the day of discharge through study completion, an average of 28 weeks, in sohag university hospital
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