NCT05944458

Efficacy of Intravenous N-Acetylcysteine in Preventing Linezolid-Induced Thrombocytopenia in Critically Ill Patients

Efficacy of Intravenous N-Acetylcysteine in Preventing Linezolid-Induced Thrombocytopenia in Critically Ill Patients: A Double-Blind Randomized Placebo-Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Helwan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

* Study the effect of acetylcysteine on decreasing the incidence of LIT in critically ill patients. * Study the impact of acetylcysteine on the time to onset of LIT and the time to recovery of platelets.

Detailed description

Primary outcome: difference in incidence of LIT between patients who received NAC and patients who didn't. * Primary outcome definition: Defined as platelets \< 150000 OR decrease \> 50% of baseline platelets. * Secondary outcome: difference in Time to onset of LIT and time to recovery between the 2 groups. Blood products transfusion, bleeding, length of stay, and in-hospital mortality incidence between 2 groups. * Secondary outcome definitions: after having thrombocytopenia, regardless of discontinuation of linezolid, recovery is defined as the restoration and maintenance of platelet counts \> 70% of baseline values.

Conditions

• Linezolid
• Antioxidant
• Thrombocytopenia
• Critical Illness
• ICU

Interventions

Type	Name	Description
DRUG	N acetyl cysteine	Fluimucil 600 mg iv to be taken twice daily as infusion
DRUG	Placebo	20 ml normal saline iv every 12 hours

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2023-07-13
• Last updated: 2025-07-14

Locations

1 site across 1 country: Egypt