Usage of Meropenem/Gentamicin Versus Ceftazidime/Avibactam in ARDS

King Abdul Aziz Specialist Hospital

Status: Completed

Conditions: Ventilator Associated Pneumonia

Treatments: Drug: ceftazidime 2 grams and avibactam 500; Device: ventilator; Drug: meropenem

Study type: Observational

Funder types: NETWORK

Identifiers

NCT04402359

ICU-3-20

Details and patient eligibility

About

This was a prospective double blind study conducted on 200 polytrauma patients admitted to King Abdul-Aziz Specialized Hospital, Taif, KSA between July 2018 and December 2019 in surgical ICU. All patients were having severe chest trauma, contused lungs either with or without severe head trauma.

Full description

Patients of Group A received meropenem one gram slowly IV infusion every 8 hours for 14 days and gentamicin 7 milligram (mg)/ Kilogram body weight per day slowly IV infusion once daily only for one week, while patients of Group B received ceftazidime 2 grams and avibactam 500 mg every 8 hours for 14 days in solution for injection(sodium chloride 9 mg/mL (0.9%), sodium chloride 4.5 mg/mL, dextrose 25 mg/mL, 0.45% sodium chloride, 2.5% dextrose and/or Lactated Ringer's solution). The solution for injection should be administered over 120 minutes. • Temperature was measured every 3 hours for 2 weeks. • ABG was done every 8 hours for 2 weeks. • CBC including white cell count was done daily and for 2 weeks. • Complete renal functions daily (urea and creatinine serum level) for 2 weeks. Any patient showing rise in the creatinine level was recorded and excluded from the study. • Chest X-ray for all the patients was ordered after intubation and with onset of ventilation and every 24 hours for 2 weeks. • All patients received anti-stress (Omeprazole 20 mg IV every 12 hours). • Oro-gastric tubes were inserted to all patients and feeding was started within 24 hours.Daily evaluation for conscious level and need for sedation and ventilation were done for all patients. • Tracheobronchial lavage was obtained by bronchoscopy 2 times a week and sent for qualitative culture for 2 weeks. • Blood culture was also taken 2 times per week for 2 weeks. • The planned duration of the study is two weeks from diagnosis of VAP and starting the antibiotics so any patients who failed to be weaned within this period were considered morbidity and recorded.

Enrollment: 200 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

patients with respiratory failure diagnosed by ABG,chest Xray, and clinical by Arterial oxygen low saturation.

Exclusion Criteria:

• Any other types of respiratory failure rather than trauma

Trial design

200 participants in 2 patient groups

Group A

Description:

Patients of Group A received meropenem one gram slowly IV infusion every 8 hours for 14 days and gentamicin 7 milligram (mg)/ Kilogram body weight per day slowly IV infusion once daily only for one week after ventilator for 2 weeks

Treatment:

Device: ventilator

Drug: meropenem

Group B

Description:

received ceftazidime 2 grams and avibactam 500 mg every 8 hours for 14 days in solution for injection(sodium chloride 9 mg/mL (0.9%), sodium chloride 4.5 mg/mL, dextrose 25 mg/mL, 0.45% sodium chloride, 2.5% dextrose and/or Lactated Ringer's solution). The solution for injection should be administered over 120 minutes.after ventilator for 2 weeks

Treatment:

Device: ventilator

Drug: ceftazidime 2 grams and avibactam 500