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NCT03329443 Clinical Trial

The Effect of Spironolactone on Acute Kidney Injury in Patients Undergoing Coronary Angiography

Acute Kidney Injury Clinical Trial

Official title:
The Effect of Spironolactone on Acute Kidney Injury in Patients Undergoing Coronary Angiography

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03329443
Other study ID # CT00964
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 1, 2017
Est. completion date September 4, 2018

Study information
Verified date September 2018
Source University of Baghdad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

an interventional study to measure the possible effects of spironolactone ( an aldosterone antagonist) on the incidence of acute kidney injury after coronary angiography

Recruitment information / eligibility
Status Completed
Enrollment 490
Est. completion date September 4, 2018
Est. primary completion date September 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients admitted to angiography unit

- over 18

- informed consent

Exclusion Criteria:

- acute renal failure before 7 days

- spironolactone contraindications

- hyperkalemia (S.K. >5.5 mEq/L)

- documented tumor

- actively taking NSAIDs, Ciclosporin, Cisplatin,

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Spironolactone
each patient will receive 200 mg of spironolactone as per his/her angiography premedications
• Placebo Oral Tablet
Each patient will receive a placebo tablet as per his/her angiography premedications

Locations
Country Name City State
Iraq Al-Sader Teaching Hospital Basrah

Sponsors (2)
Lead Sponsor Collaborator
Alhasan Mujtaba Abdul-Wahid Ministry of Health-Basra Health Directorate-Al-Sader Teaching Hospital

Country where clinical trial is conducted

Iraq, 

Outcome
Type Measure Description Time frame Safety issue
Other safety outcome: serum potassium serum potassium after 6 hrs of angio 6 hrs
Primary Acute kidney injury by K-DIGO guidelines an absolute elevation of serum creatinine of 0.5mg/dl or 25% above baseline 48-72 hrs
Secondary acute kidney injury by NGAL assessment of serum NGAL at admission and after 6 hrs to detect possible AKI in selected patients 6 hours
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