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Effect of add-on therapy with Ranolazine on reducing tissue ischemia and improvement of clinical outcome in patients with severe burn

Effect of add-on therapy with Ranolazine on reducing tissue ischemia and improvement of clinical outcome in patients with severe burn: A clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210524051384N10
Enrollment
78
Registered
2023-06-20
Start date
2023-06-22
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn. Burn and corrosion of head, face, and neck

Interventions

Intervention 1: Intervention group: The treatment with oral ranolazine 500 mg tablets for patients in the intervention group will be started in the emergency room in such a way that the maximum time i

Sponsors

Rasht University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age range from 18 to 65 years Acute burn in less than 6 hours Total body surface area (TBSA) between 20 - 50% patients of American Society of Anesthesiologists (ASA) class I (a normal healthy person) Fill out the informed consent

Exclusion criteria

Exclusion criteria: Having severe hypertension blood pressure (BP) = 160/90 mmHg or systolic pressure below 100 mmHg Ischemic changes in electrocardiogram (ECG) Heart rate less than 70 beats per minute Pregnant women Peripheral vascular disease Presence of inhalation injury Presence of burn shock (including decreased cardiac output, increased vascular resistance, hypovolemia and hypoperfusion following severe burns) Electrical and chemical burns Kidney or liver failure caused by burns (according to the kidney and liver metabolism of the drug) Presence of drug interactions with the patient's previous medications

Design outcomes

Primary

MeasureTime frame
Graft to TBSA (total body surface area) percent ratio. Timepoint: At discharge. Method of measurement: Measurements based on Wallace criteria.;Mortality. Timepoint: At discharge. Method of measurement: Based on the clinical outcome recorded in the patients' files.

Secondary

MeasureTime frame
Length of hospital stay. Timepoint: At discharge. Method of measurement: Based on patient's file.;SIRS (Systemic inflammatory response syndrome). Timepoint: On the 1st, 3rd and 7th days of hospitalization. Method of measurement: Based on criteria including temperature, heart rate, respiratory rate, and WBC (white blood cell) count.;Infection. Timepoint: On the 1st, 3rd and 7th days of hospitalization. Method of measurement: Based on clinical decision of doctor.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammad Reza Mobayen

Rasht University of Medical Sciences

Maziar.mobayen@gmail.com+98 13 3336 8540

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026