Linezolid, Antioxidant, Thrombocytopenia, Critical Illness, ICU
Conditions
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.
Interventions
Fluimucil 600 mg iv to be taken twice daily as infusion
DRUGPlacebo
20 ml normal saline iv every 12 hours
Sponsors
Helwan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 | — |
Countries
Egypt
Outcome results
None listed