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

September 6, 2018 updated by: Alhasan Mujtaba Abdul-Wahid
an interventional study to measure the possible effects of spironolactone ( an aldosterone antagonist) on the incidence of acute kidney injury after coronary angiography

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

490

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Basrah, Iraq, 00964
        • Al-Sader teaching hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: Placebo Oral Tablet
Each patient will receive a placebo tablet as per his/her angiography premedications
Other Names:
  • Control group
Active Comparator: Spironolactone
Drug: Spironolactone
each patient will receive 200 mg of spironolactone as per his/her angiography premedications
Other Names:
  • Active group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute kidney injury by K-DIGO guidelines
Time Frame: 48-72 hrs
an absolute elevation of serum creatinine of 0.5mg/dl or 25% above baseline
48-72 hrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute kidney injury by NGAL
Time Frame: 6 hours
assessment of serum NGAL at admission and after 6 hrs to detect possible AKI in selected patients
6 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety outcome: serum potassium
Time Frame: 6 hrs
serum potassium after 6 hrs of angio
6 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alhasan Mujtaba Abdul-Wahid

Collaborators

Ministry of Health-Basra Health Directorate-Al-Sader Teaching Hospital

Investigators

  • Principal Investigator: Alhasan Mujtaba, BCPS, Baghdad University/College of Pharmacy/Department of Clinical Pharmacy
  • Study Chair: Mohammed A Taher, Ph.D., Baghdad University/College of Pharmacy/Department of Biochemistry
  • Study Director: Mazin A Hazzaa', Ph.D., Al-Sader teaching Hospital/Basra Cardiac Center/M.D. Cardiologist
  • Study Director: Hassan M Al Rubaye, Ph.D, Al-Sader teaching Hospital/Basra Cardiac Center/M.D. Cardiologist
  • Study Director: Assad H Kata, Ph.D, Al-Sader teaching Hospital/Basra Cardiac Center/M.D. Cardiologist
  • Study Director: Hayder K Abdullkreem, M.Sc, Head of the clinical laboratory department/ Al-Sader teaching hopital
  • Study Director: Hamid A Abdulsada, Ph.D, Al-Sader teaching Hospital/Basra Cardiac Center/M.D. Cardiologist
  • Study Director: Abdul Ameer A Abdul Hameed, PH.D, Al-Sader teaching Hospital/Basra Cardiac Center/M.D. Cardiologist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 4, 2018

Study Registration Dates

First Submitted

October 30, 2017

First Submitted That Met QC Criteria

October 30, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT00964

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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