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

Phase 2

Completed

• Conditions: Contrast-induced Nephropathy; Acute Kidney Injury; IHD
• Interventions: Drug: Placebo Oral Tablet; Drug: Spironolactone

• Registration Number: NCT03329443
• Lead Sponsor: Alhasan Mujtaba Abdul-Wahid

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-10-30
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-11-06
• Status Verified: 2018-09
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-04
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 490

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo Oral Tablet	-
Spironolactone	Spironolactone	-

Primary Outcome Measures

Name	Time	Method
Acute kidney injury by K-DIGO guidelines	48-72 hrs	an absolute elevation of serum creatinine of 0.5mg/dl or 25% above baseline

Secondary Outcome Measures

Name	Time	Method
acute kidney injury by NGAL	6 hours	assessment of serum NGAL at admission and after 6 hrs to detect possible AKI in selected patients

Trial Locations

Locations (1)

Al-Sader Teaching Hospital; 🇮🇶 Basrah, Iraq