The Role of Levosimendan as Inotropic Agent in Acute Aluminum Phosphide-induced Cardiotoxicity

NCT06478667 | Completed Phase 3

• 1 other identifier: Levosimendan in AlP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the potential role of levosimendan as an inotropic agent in aluminum phosphide-induced cardiotoxicity

Conditions

Acute Myocarditis

Outcome Measures

Primary Outcomes (1)

• systolic blood pressure

  Maintain systolic blood pressure with adequate organ perfusion

  acute phase of myocarditis in 24 hours

Study Arms (2)

control group

PLACEBO COMPARATOR

will receive the traditional supportive treatment according to (PCC-ASUH) protocol • Interventions: Inotropic agent: Dobutamine Vasopressor: norepinephrine N-acetylcysteine: antioxidant Magnesium Sulphate: antiarrhythmic Sodium Bicarbonate Powder and ondansetron hydrocortisone 100 mg every 4-6h

Drug: levosemindan

levosemindan group

ACTIVE COMPARATOR

will receive the traditional supportive treatment without dobutamine as inotropic agent instead levosimendan will be started in bolus dose of 6-12 µg/kg over 10 minutes followed by infusion of 0.05 - 0.2µg/kg/min with adjusting infusion rate according to response and adverse events.

Drug: levosemindan

Interventions

levosemindan DRUG

inotropic agent

control group; levosemindan group

Eligibility Criteria

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

You may qualify if:

• Patients with acute ALP intoxication admitted to ICU of PCC-ASUH and developed cardiotoxicity with Poisoning Severity Score (PSS) 2 (moderate) or 3 (severe) that led to cardiogenic shock and necessitated administration of vasoactive medications

You may not qualify if:

• Pregnant patients
• The presence of pre-existing diseases such as hematologic, pulmonary, hepatic, renal, immunologic, central nervous system, or endocrine system disorders that made patients unsuitable for the present study.
• Patients with underlying cardiac disease and ECG changes, especially prolonged QTc intervals.
• Patients co-ingested drugs or toxins with cardiovascular toxicity.
• Patients had been previously administered with inotropic agent other than agents under the current study as a preconsultation treatment.
• Patients had received any other investigational medicinal products within 30 days or were enrolled in any other interventional trials with the potential to interact with Levosimendan or affect ALP induced cardiotoxicity

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Poison Control Center

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: June 27, 2024
• Study Start: December 20, 2024
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: April 30, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)