Sepsis
Conditions
Brief summary
In this study, our aim is to investigate the role tranexamic acid in modulating inflammation in patients with sepsis.
Detailed description
A written informed consent will be taken from the patients or their relatives.Patients will be assigned randomly to two groups (40 subjects each) with qSOFA ≥2. In (Group T) administer 1 gram of tranexamic acid (TXA) in 100 ml of 0.9% normal saline, intravenous over 10 minutes as soon as possible but no later than three hours after diagnosis, infuse a second gram of tranexamic acid (TXA) IV over 8 hours in 0.9% normal saline for the first 3 days. In (Group C) administer the same volume (100 ml normal saline)and same duration (first three days)for controlled patients.
Interventions
DRUGTranexamic acid
administer 1 gram of TXA in 100 ml of 0.9% normal saline, intravenous over 10 minutes as soon as possible but no later than three hours after diagnosis, infuse a second gram of TXA IV over 8 hours in 0.9% normal saline for first 3 days.
OTHER0.9% saline
administer the same volume (100ml normal saline) and same duration (first three days).
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults (age 18-65 years) of American society of anesthesiologists (ASA) I-II who will be diagnosed with sepsis by qSOFA ≥2 * & needed ICU admission.
Exclusion criteria
* Chronic renal failure * Liver cirrhosis * Bleeding disorders or current anticoagulant therapy * Pregnancy or breastfeeding * Impaired color vision * Severe vascular ischemia, history of venous thrombosis & pulmonary embolism * Long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before ICU admission * Allergy to tranexamic acid (TXA)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICU mortality | 7days | Short-term ICU mortality within 7days of admission and intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neutrophil/lymphocyte ratio (NLR) | 4 days | From complete blood count, divide absolute number of neutrophils on lymphocyte to assess and follow up the inflammatory response in sepsis |
| Interleukin-6 (IL-6) serum level | 4 days | Measurement of interleukin-6 (IL-6) serum level to assess and follow up the inflammatory response in sepsis |
| Glasgow coma scale (GCS) | 5 days | Assessing the conscious level of patients by Glasgow Coma Scale (3\_15)after ICU admission and intervention start give an idea on brain dysfunction in sepsis where high scores are associated with low mortality and low scores are associated with high mortality |
| ICU stay | 7 days | Days of patients admission in ICU |
| Length of hospitalization | 7 days | Days of patients admission in hospital |
Countries
Egypt
Contacts
Primary ContactOmar Soliman
Outcome results
None listed