Efficacy of Intravenous N-Acetylcysteine in Preventing Linezolid-Induced Thrombocytopenia in Critically Ill Patients
- Conditions
- LinezolidAntioxidantThrombocytopeniaICUCritical Illness
- Interventions
- Drug: Placebo
- Registration Number
- NCT05944458
- Lead Sponsor
- Helwan University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- Adult patients (age ≥ 18 years)
- Admitted to the Intensive Care Unit (ICU)
- Candidates for intravenous linezolid therapy for ≥ 48 hours
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description N-acetylcysteine group N acetyl cysteine Generic name: N-acetylcysteine. * Trade name: Fluimucil. * Company: Zambon. * Dosage form: ampoules for intravenous administration. * Dose: 600mg taken every 12 hours daily with a fixed dose as there is no need for renal or hepatic adjustment, starting with the inception of linezolid therapy. * Duration: for 14 days post linezolid discontinuation or until ICU discharge, whichever came first. Standard of care Placebo They will receive standard of care (Platelets monitoring daily, linezolid discontinuation if platelet count less than 50000 or clinically appropriate and platelet transfusion according to the institutional protocol) plus placebo (20 ml normal saline twice daily)
- Primary Outcome Measures
Name Time Method difference in incidence of LIT between patients who received NAC and patients who didn't. From starting linezolid untill 14 days after linezolid discontinuation or ICU discharge whichever comes first. Defined as platelets \< 150000 OR decrease \> or = 50% of baseline platelets.
- Secondary Outcome Measures
Name Time Method Blood products transfusion, bleeding, length of ICU stay, and in-ICU mortality incidence between 2 groups. From start linezolid until ICU discharge Difference in time to thrombocytopenia onset between the 2 groups From linezolid start date until date of first thrombocytopenia event, assessed up to 14 days after linezolid discontinuation or ICU discharge whichever comes first Difference in time to platelet recovery between the 2 groups From thrombocytopenia onset to recovery, assesed up to 14 days after linezolid discontinuation or ICU discharge whichever comes first after having thrombocytopenia, regardless of discontinuation of linezolid, recovery is defined as the restoration and maintenance of platelet counts \> 70% of baseline values
Trial Locations
- Locations (1)
15 May hospital
🇪🇬Cairo, Egypt
15 May hospital🇪🇬Cairo, Egypt