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

Helwan University250 enrolled

Overview

* 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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

250

Conditions

Linezolid Antioxidant Thrombocytopenia Critical Illness ICU

Interventions

N acetyl cysteineDRUG

Fluimucil 600 mg iv to be taken twice daily as infusion

PlaceboDRUG

20 ml normal saline iv every 12 hours

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients (age ≥ 18 years) * Admitted to the Intensive Care Unit (ICU) * Candidates for intravenous linezolid therapy for ≥ 48 hours Exclusion Criteria: * Baseline platelet count \< 50 × 10⁹/L * Diagnosis of malignancy * Receipt of any chemotherapeutic agent within the past 6 months * Positive COVID-19 RT-PCR test at admission * Diagnosis of immune thrombocytopenia * Presence of splenomegaly * Presence of liver cirrhosis * Presence of hepatitis C * Refusal to provide informed consent

Locations (1)

15 May hospital

Cairo, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

difference in incidence of LIT between patients who received NAC and patients who didn't.

Defined as platelets \< 150000 OR decrease \> or = 50% of baseline platelets.

Time frame: From starting linezolid untill 14 days after linezolid discontinuation or ICU discharge whichever comes first.

Secondary Outcomes

Blood products transfusion, bleeding, length of ICU stay, and in-ICU mortality incidence between 2 groups.

Time frame: From start linezolid until ICU discharge

Difference in time to platelet recovery between the 2 groups

after having thrombocytopenia, regardless of discontinuation of linezolid, recovery is defined as the restoration and maintenance of platelet counts \> 70% of baseline values

Time frame: From thrombocytopenia onset to recovery, assesed up to 14 days after linezolid discontinuation or ICU discharge whichever comes first

Difference in time to thrombocytopenia onset between the 2 groups

Time frame: From linezolid start date until date of first thrombocytopenia event, assessed up to 14 days after linezolid discontinuation or ICU discharge whichever comes first

Data from ClinicalTrials.gov

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