Clinical trial

Preventing Cefoperazone/Sulbactam Induced Coagulopathy in Critically Ill Egyptian Patients: Efficacy of Vitamin K Prophylactic Doses

Name

Vit. K for SULBinCo

Description

Evaluating the effect of prophylactic doses of vitamin K in preventing the adverse effect of cefoperazone/sulbactam induced coagulopathy in critically ill patients.

Trial arms

Trial start

2023-02-25

Estimated PCD

2023-10-05

Trial end

2023-10-05

Status

Completed

Phase

Early phase I

Treatment

Vitamin K

Coadministration of vitamin K with the first dose of cefoperazone/sulbactam

Arms:

Intervention group

Size

Primary endpoint

Number of Participants with changes in INR level

During the duration of cefoperazone/sulbactam treatment up to 2 weeks

Eligibility criteria

Inclusion Criteria: * ICU admitted patients on treatment or prophylactic doses of cefoperazone/sulbactam. Exclusion Criteria: * Patients' aged \<18 years * Pregnancy or breastfeeding women * Active bleeding or bleeding disorder * Patients having an abnormal baseline coagulation profile. * Patients administer total parenteral nutrition with regular vitamin k supplements. * Refusal to sign the written informed consent.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 56, 'type': 'ACTUAL'}}

Updated at

2023-10-10

1 organization

1 product

1 indication

Organization

Helwan University

Product

Vitamin K

Indication

adverse effect of antibiotics