Neurologic Complication, Neurosurgery
Conditions
Brief summary
A prospective, open-label, single center, controlled trial. 44 patients that underwent neurosurgery or presented meningitis signs, for whom Clindamycin add-on therapy to assess its effect on neurological complication in relation to Neuron-specific enolase (NSE) and Neurotensin biomarkers levels.
Detailed description
1. This is a prospective, open-label, single center, controlled trial. 44 patients that underwent neurosurgery or presented meningitis signs, for whom Clindamycin add-on therapy is prescribed (900 - 1200 mg twice daily) will be recruited from Alexandria University Main Hospital. 2. Whole blood samples will be collected for Analyses of Neuron-specific enolase (NSE) and Neurotensin will be detected by ELISA. 3. All patients will be assessed for complete blood count (CBC), kidney function, liver function, Methodology * Patients will be enrolled if they underwent surgery or presented with clinical signs of meningitis. * All enrolled 44 patients will be divided into two groups; Group I are patients who will receive clindamycin added-on therapy. Group II patients will be managed with the standard regimen. * Complete physical, laboratory, and radiological assessment will be done for all patients * All patients will be followed up during 2 weeks period. * Serum samples will be collected for measuring the biomarkers.
Interventions
DRUGClindamycin 600 mg
Clindamycin 900 - 1200 mg TWICE per day during 2 weeks period.
DRUGstandard regimen
standard regimen
Sponsors
Damanhour University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
All enrolled 44 patients will be divided into two groups; Group I are patients who will receive clindamycin added-on therapy. Group II patients will be managed with the standard regimen.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1\) Adult patients will be enrolled if they underwent neurosurgery or presented with clinical signs of meningitis.
Exclusion criteria
1. Age lower than 18. 2. Females with a positive pregnancy test. 3. Known congestive heart failure or ischemic heart disease. 4. Any injury that disturbs the examination (high cervical cord injury or locked-in syndrome, could be a source of bias). 5. Severe brain disease (For example CVA history or brain tumor). 6. Renal failure with GFR lower than 60 ml/min. 7. Patients with unknown identity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurotensin Blood Concentration | 2 Weeks | Serum Level of Neurotensin pg/ml |
| Neuron-specific enolase (NSE) Blood Concentration | 2 weeks | Serum Level of NSE pg/ml |
Countries
Egypt
Outcome results
None listed