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

NCT06286059 | Recruiting Phase 2

• 1 other identifier: Phentolamine for CA-AKI
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Rate of CA-AKI

  A rise in creatinine of ≥ 50% of baseline or 0.3 mg/dL from the pre-contrast value within 48-72 hours of intravascular administration of a contrast medium.

  3 days post-PCI

Secondary Outcomes (10)

• Peak of serum creatinine elevation

  7 days

• Duration of CA-AKI

  14 days

• Change in HR

  12 hours post-PCI

• Change in SBP

  12 hours post-PCI

• Change in DBP

  12 hours post-PCI

Study Arms (2)

Control group

NO INTERVENTION

Patients will receive conventional management including high dose atorvastatin and isotonic (0.9%) saline intravenous (IV) infusion at a rate of 1 ml/kg/hr for 12 hours or reduced to 0.5 ml/kg/hr if the patient's LVEF \< 40% or overt heart failure.

Phentolamine group

EXPERIMENTAL

In addition to the conventional management, patients will receive phentolamine infusion.

Drug: Phentolamine

Interventions

Phentolamine DRUG

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.

Also known as: Rogitamine

Phentolamine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Badr university hospital

Badr, Cairo Governorate, Egypt

RECRUITING

Related Publications (6)

• Hamila MA, El Ghawaby H, Zaki M, Soliman M, Gabr K. Association of periprocedural phentolamine infusion with favorable outcome in patients with chronic kidney disease and chronic coronary syndrome undergoing coronary catheterization: a prospective randomized controlled pilot study. BMC Nephrol. 2022 Dec 31;23(1):416. doi: 10.1186/s12882-022-03050-9.

  PMID: 36585656 BACKGROUND

• Kelesoglu S, Yilmaz Y, Elcik D, Cetinkaya Z, Inanc MT, Dogan A, Oguzhan A, Kalay N. Systemic Immune Inflammation Index: A Novel Predictor of Contrast-Induced Nephropathy in Patients With Non-ST Segment Elevation Myocardial Infarction. Angiology. 2021 Oct;72(9):889-895. doi: 10.1177/00033197211007738. Epub 2021 Apr 8.

  PMID: 33827291 BACKGROUND

• Lu Y, Wang Y, Zhou B. Predicting long-term prognosis after percutaneous coronary intervention in patients with acute coronary syndromes: a prospective nested case-control analysis for county-level health services. Front Cardiovasc Med. 2023 Dec 4;10:1297527. doi: 10.3389/fcvm.2023.1297527. eCollection 2023.

  PMID: 38111892 BACKGROUND

• Mehran R, Owen R, Chiarito M, Baber U, Sartori S, Cao D, Nicolas J, Pivato CA, Nardin M, Krishnan P, Kini A, Sharma S, Pocock S, Dangas G. A contemporary simple risk score for prediction of contrast-associated acute kidney injury after percutaneous coronary intervention: derivation and validation from an observational registry. Lancet. 2021 Nov 27;398(10315):1974-1983. doi: 10.1016/S0140-6736(21)02326-6. Epub 2021 Nov 15.

  PMID: 34793743 BACKGROUND

• Ozkok S, Ozkok A. Contrast-induced acute kidney injury: A review of practical points. World J Nephrol. 2017 May 6;6(3):86-99. doi: 10.5527/wjn.v6.i3.86.

  PMID: 28540198 BACKGROUND

• Walker H, Guthrie GD, Lambourg E, Traill P, Zealley I, Plumb A, Bell S. Systematic review and meta-analysis of prophylaxis use with intravenous contrast exposure to prevent contrast-induced nephropathy. Eur J Radiol. 2022 Aug;153:110368. doi: 10.1016/j.ejrad.2022.110368. Epub 2022 May 23.

  PMID: 35636024 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Interventions

Phentolamine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yasser Sadek, Professor

  Helwan University

  STUDY CHAIR

• Arafa Gomaa, MD

  Helwan University

  STUDY DIRECTOR

Central Study Contacts

Mohammed Soliman

CONTACT

+201032137563; Mohammed_Mostafa@med.helwan.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single Blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Randomised controlled clinical trial

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: March 7, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 months after end of the study duration
• Access Criteria: Supporting information will be added to the original study during publishing

Locations

EG (1)