Role of Amlodipine in Reduction of CIN

December 5, 2025 updated by: Andrew Samy Shafeek Shehata, Minia University

The Effect of Low Dose Oral Amlodipine in Renal Protection From Contrast Induced Nephropathy in Diabetic Patients in Intensive Care Unit

The aim is to assess the benefit of low dose oral amlodipine in renal protection from contrast induced nephropathy in diabetic patients in intensive care unit

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Early Phase 1

Contacts and Locations

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

Study Contact

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • adult patients of both sexes (18:70) diabetic patients with serum creatinine below 1.2 hemodynamically stable patients ASA physical status 2,3

Exclusion Criteria:

  • patient refusal patients of chronic kidney diseases NPO patients serum creatinine above 1.2 Hypertensive patients

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
this group who undergoing iv contrast will receive hydration only
Other: Hydration
before the procedure patients will recieve iv bolus of 250 ml saline followed by continous infusion of 100 ml/h of normal saline
Other: Amlodipine group
this group will receive hydration and amlodipine
Other: Hydration
before the procedure patients will recieve iv bolus of 250 ml saline followed by continous infusion of 100 ml/h of normal saline
Drug: Calcium channel blocker
amlodipine group will receive low dose oral amlodipine ( 5 mg ) before iv contrast and every 12 hour for 48 hour
Other Names:
  • amlodipine ( 5mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measuring serum creatinine level
Time Frame: baseline
measuring serum creatinine level before the procedure and every day for 48 hours after
baseline

Collaborators and Investigators

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

Sponsor

Minia University

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 (Estimated)

December 20, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

December 5, 2025

First Submitted That Met QC Criteria

December 5, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Amlodipine role in CIN

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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