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

Primary Purpose

Acute Kidney Injury, IHD, Contrast-induced Nephropathy

Status
Completed
Phase
Phase 2
Locations
Iraq
Study Type
Interventional
Intervention
Spironolactone
Placebo Oral Tablet
Sponsored by
Alhasan Mujtaba Abdul-Wahid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring spironolactone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Al-Sader Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

Spironolactone

Arm Description

Outcomes

Primary Outcome Measures

Acute kidney injury by K-DIGO guidelines
an absolute elevation of serum creatinine of 0.5mg/dl or 25% above baseline

Secondary Outcome Measures

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

Full Information

First Posted
October 30, 2017
Last Updated
September 6, 2018
Sponsor
Alhasan Mujtaba Abdul-Wahid
Collaborators
Ministry of Health-Basra Health Directorate-Al-Sader Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03329443
Brief Title
The Effect of Spironolactone on Acute Kidney Injury in Patients Undergoing Coronary Angiography
Official Title
The Effect of Spironolactone on Acute Kidney Injury in Patients Undergoing Coronary Angiography
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
September 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alhasan Mujtaba Abdul-Wahid
Collaborators
Ministry of Health-Basra Health Directorate-Al-Sader Teaching Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, IHD, Contrast-induced Nephropathy
Keywords
spironolactone

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
490 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
Spironolactone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Other Intervention Name(s)
Active group
Intervention Description
each patient will receive 200 mg of spironolactone as per his/her angiography premedications
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Other Intervention Name(s)
Control group
Intervention Description
Each patient will receive a placebo tablet as per his/her angiography premedications
Primary Outcome Measure Information:
Title
Acute kidney injury by K-DIGO guidelines
Description
an absolute elevation of serum creatinine of 0.5mg/dl or 25% above baseline
Time Frame
48-72 hrs
Secondary Outcome Measure Information:
Title
acute kidney injury by NGAL
Description
assessment of serum NGAL at admission and after 6 hrs to detect possible AKI in selected patients
Time Frame
6 hours
Other Pre-specified Outcome Measures:
Title
safety outcome: serum potassium
Description
serum potassium after 6 hrs of angio
Time Frame
6 hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alhasan Mujtaba, BCPS
Organizational Affiliation
Baghdad University/College of Pharmacy/Department of Clinical Pharmacy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammed A Taher, Ph.D.
Organizational Affiliation
Baghdad University/College of Pharmacy/Department of Biochemistry
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mazin A Hazzaa', Ph.D.
Organizational Affiliation
Al-Sader teaching Hospital/Basra Cardiac Center/M.D. Cardiologist
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hassan M Al Rubaye, Ph.D
Organizational Affiliation
Al-Sader teaching Hospital/Basra Cardiac Center/M.D. Cardiologist
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Assad H Kata, Ph.D
Organizational Affiliation
Al-Sader teaching Hospital/Basra Cardiac Center/M.D. Cardiologist
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hayder K Abdullkreem, M.Sc
Organizational Affiliation
Head of the clinical laboratory department/ Al-Sader teaching hopital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hamid A Abdulsada, Ph.D
Organizational Affiliation
Al-Sader teaching Hospital/Basra Cardiac Center/M.D. Cardiologist
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Abdul Ameer A Abdul Hameed, PH.D
Organizational Affiliation
Al-Sader teaching Hospital/Basra Cardiac Center/M.D. Cardiologist
Official's Role
Study Director
Facility Information:
Facility Name
Al-Sader Teaching Hospital
City
Basrah
ZIP/Postal Code
00964
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29785539
Citation
Mujtaba A, Taher MA, Hazza MA, Al-Rubaye HM, Kata AH, AbdulWahab H, AbdulBari A, AlRubay HK. The Effect of Spironolactone on the Incidence of Contrast-Induced Nephropathy in Patients Undergoing Cardiac Catheterization: Study Design and Rationale. Cardiol Ther. 2018 Jun;7(1):101-106. doi: 10.1007/s40119-018-0112-3. Epub 2018 May 21.
Results Reference
derived

Learn more about this trial

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

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