NCT07291375

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
1mo left

Started Dec 2025

Shorter than P25 for early_phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Dec 2025Jul 2026

First Submitted

Initial submission to the registry

December 5, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

December 20, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

December 5, 2025

Last Update Submit

December 5, 2025

Conditions

Contrast-induced Nephropathy

Outcome Measures

Primary Outcomes (1)

  • measuring serum creatinine level

    measuring serum creatinine level before the procedure and every day for 48 hours after

    baseline

Study Arms (2)

Control group

OTHER

this group who undergoing iv contrast will receive hydration only

Other: Hydration

Amlodipine group

OTHER

this group will receive hydration and amlodipine

Drug: Calcium channel blockerOther: Hydration

Interventions

HydrationOTHER

before the procedure patients will recieve iv bolus of 250 ml saline followed by continous infusion of 100 ml/h of normal saline

Amlodipine groupControl group
Calcium channel blockerDRUG

amlodipine group will receive low dose oral amlodipine ( 5 mg ) before iv contrast and every 12 hour for 48 hour

Also known as: amlodipine ( 5mg)
Amlodipine group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Calcium Channel BlockersAmlodipine

Intervention Hierarchy (Ancestors)

Membrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesCalcium-Regulating Hormones and AgentsPhysiological Effects of DrugsCardiovascular AgentsTherapeutic UsesDihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Andrew Shehata, Master

CONTACT

0201067820073andrewlengouini.95@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Andrew Samy Shafeek

Study Record Dates

First Submitted

December 5, 2025

First Posted

December 18, 2025

Study Start

December 20, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

December 18, 2025

Record last verified: 2025-12