Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate) Health Condition 2: N184- Chronic kidney disease, stage 4 (severe) Health Condition 3: N185- Chronic kidney disease, stage 5
Conditions
Interventions
Control Intervention1: CKD and Cefoperazone Group:: We will monitor patients with chronic kidney disease (CKD) who are
receiving intravenous Cefoperazone or Cefoperazone plus Sulbactam. This group wi
Sponsors
Kasturba Medical College and Hospital Manipal
Eligibility
Inclusion criteria
Inclusion criteria: patients who are having normal coagulation parameters prior to starting renal function adjusted dose of intravenous antibiotics, and were anticipated to continue the same intravenous antibiotic medication for at least five days are included in the study. Inclusion Criteria for Control Group (Patients with Normal Renal Function) 1. No prior history of kidney disease with an eGFR more than 60 mL/min/1.73m2. 2. Receiving intravenous Cefoperazone or Cefoperazone plus Sulbactam for bacterial infections. Inclusion Criteria for CKD and Cefoperazone Group 1. Patients diagnosed with CKD stage 3 or worse and not on renal replacement therapy, confirmed by established criteria (e.g., eGFR more than 60 mL/min/1.73m2 for 3 months or more). 2. Patients receiving intravenous Cefoperazone or Cefoperazone plus Sulbactam for the management of bacterial infections. Inclusion Criteria for CKD and Other Antibiotics Group: 1. Patients diagnosed with CKD stage 3 or worse, confirmed by established criteria (e.g., eGFR less than 60 mL/min/1.73m2 for 3 months or more). 2. Patients receiving intravenous Meropenem or Amoxicillin plus Clavulanic acid for the management of bacterial infections.
Exclusion criteria
Exclusion criteria: 1. Pre-existing Coagulopathy: Patients with known coagulopathy prior to the initiation of the study. 2. Liver Disorders: Patients with clinically significant liver disease, including cirrhosis, hepatitis, and any condition that could affect liver function tests. 3. Concurrent Anticoagulant Therapy: Patients receiving anticoagulant medications such as warfarin, heparin, or direct oral anticoagulants (DOACs). 4. Bleeding Disorders: Patients with inherited or acquired bleeding disorders. 5. Recent Surgery or Trauma: Patients who have undergone major surgery or experienced significant trauma within the past 30 days. 6. Pregnancy and Lactation: Pregnant or breastfeeding women. 7. Other Severe Comorbidities: Patients with other severe comorbidities that could affect study outcomes, such as advanced malignancies, severe heart failure (NYHA class IV), or severe respiratory disease. 8. Hypersensitivity: Patients with a known hypersensitivity to any of the study antibiotics or their components. 9. Concurrent use of drugs known to have significant interaction with cefoperazone, sulbactam, meropenem, amoxicillin and clavulanic acid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Prothrombin Time (PT) Changes in Activated Partial Thromboplastin Time (APTT) Platelet Counts.Timepoint: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of major bleeding/hemorrhagic eventTimepoint: 7 days | — |
Countries
India
Contacts
Public ContactDr Rajesh Vilakkathala
Manipal academy of higher education
Outcome results
None listed