Using phentolamine to prevent kidney injury after complex heart procedures
Protective Efficacy of Phentolamine in Patients at High Risk of Contrast-Associated Acute Kidney Injury After Complex Percutaneous Coronary Intervention
PHASE2; PHASE3 · Helwan University · NCT06286059
This study is testing if a medication called phentolamine can help prevent kidney injury in patients with heart disease who are at high risk during certain heart procedures.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Helwan University (other) |
| Locations | 1 site (Badr, Cairo) |
| Trial ID | NCT06286059 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of phentolamine in preventing contrast-associated acute kidney injury (CA-AKI) in patients undergoing complex percutaneous coronary interventions (PCI). It targets patients with coronary artery disease who are at high risk for developing CA-AKI, a significant complication that can lead to prolonged hospitalization and increased mortality. The study involves administering phentolamine to assess its effectiveness in reducing the incidence of CA-AKI following the use of contrast dye during PCI procedures. The research aims to provide a potential solution for managing this serious complication in high-risk patients.
Who should consider this trial
Good fit: Ideal candidates include patients with coronary artery disease who are undergoing complex PCI and are identified as high risk for CA-AKI.
Not a fit: Patients with end-stage renal disease on dialysis or those who have had failed PCI revascularization will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of kidney injury in patients undergoing complex heart procedures, improving patient outcomes and reducing healthcare costs.
How similar studies have performed: Other studies have explored interventions to prevent CA-AKI, but the specific use of phentolamine in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients admitted to CCU with CAD. * Patients underwent successful complex PCI defined as multivessel disease, more than two lesions, high coronary lesion complexity, chronic total occlusion, lesion length \>30 mm, or bifurcation. * Patients at high or very high risk for CA-AKI based on Mehran-2 CA-AKI Risk Score (Model 2). Exclusion Criteria: * Patients with end stage renal disease on regular dialysis. * Patients with failed PCI revascularization. * Patients presented with STEMI and underwent primary PCI. * Patients presented with high risk NSTEMI defined as elevated cardiac enzymes with chest pain refractory to medications and/or dynamic ST changes. * Patients presented with cardiogenic shock. * Patients presented with any degree of heart block. * Patients with of history of asthma or hypersensitive for phentolamine. * Patients on α-blockers, barbiturates or antipsychotic treatment. * Patients intolerant to phentolamin with significant hemodynamic changes defined as \>20% drop of systolic blood pressure (SBP) or \>20% increase of heart rate (HR) after loading dose of phentolamine.
Where this trial is running
Badr, Cairo
- Badr university hospital — Badr, Cairo, Egypt (RECRUITING)
Study contacts
- Study coordinator: Mohammed Soliman
- Email: Mohammed_Mostafa@med.helwan.edu.eg
- Phone: +201032137563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: CA-AKI - Contrast-Associated Acute Kidney Injury, Coronary Artery Disease, Acute Coronary Syndrome, Adrenergic Receptor Antagonist Adverse Reaction