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Efficacy of Phentolamine in Prevention of Contrast-Associated Acute Kidney Injury After Complex PCI

NCT06286059 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-18

No results posted yet for this study

Summary

To evaluate the efficacy and safety of phentolamine in prevention of CA-AKI following complex PCI in patients at high risk of CA-AKI.

Conditions

  • CA-AKI - Contrast-Associated Acute Kidney Injury
  • Coronary Artery Disease
  • Acute Coronary Syndrome
  • Adrenergic Receptor Antagonist Adverse Reaction

Interventions

DRUG

Phentolamine

In addition to the conventional management, patients will receive phentolamine (Rogitamine; Egypharma) infusion at a rate of 0.5 μgm/kg/min for the first 15 minutes after a bolus dose of 5 mg. If significant hemodynamic change occurred, the infusion then will be discontinued and the patient will be excluded. Otherwise, the dose will be uptitrated gradually 0.5-2 ugm/kg/min and the infusion will be continue for 12 hours.

Sponsors & Collaborators

  • Helwan University

    lead OTHER

Principal Investigators

  • Yasser Sadek, Professor · Helwan University

  • Arafa Gomaa, MD · Helwan University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-07
Primary Completion
2024-12-31
Completion
2025-01-31

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06286059 on ClinicalTrials.gov