Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
Study NCT ID:
NCT05944458
Status:
COMPLETED
Last Update Posted:
2025-07-14
First Post:
2023-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Intravenous N-Acetylcysteine in Preventing Linezolid-Induced Thrombocytopenia in Critically Ill Patients
Sponsor:
Helwan University
Organization:
Study Overview
Official Title:
Efficacy of Intravenous N-Acetylcysteine in Preventing Linezolid-Induced Thrombocytopenia in Critically Ill Patients: A Double-Blind Randomized Placebo-Controlled Trial
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: