Assessment of the Anti-inflammatory Effect of Heparin Infusion Versus Subcutaneous Injection in Septic Patients

• Ethical committee approval will be obtained from the Ethics Committee of the Faculty of Pharmacy, Damanhour University.
• All participants or their next kin should agree to participate in this clinical study and will provide informed consent.
• 40 participants who are critically ill with sepsis.
• The 40 participants will be randomly assigned into 2 groups:

• Standard care group: will be treated with subcutaneous heparin 5000 units three times daily for DVT prophylaxis.
• Experimental group: will be treated with heparin infusion 5000 unit\\hour for DVT prophylaxis
• All patients will be subjected directly at the time of enrollment to the following:

• Full patient history and clinical examination.
• complete blood picture, liver function tests, and renal function tests.
• The initial cause of ICU admission and define the origin of the present infection.
• Complete cultures obtained urine, blood, and sputum.
• Coagulation profile (prothrombin time, prothrombin activity, international normalization ratio (INR), clotting time, and activated partial thromboplastin time).
• Arterial blood gases analysis (including hypoxic index).
• The severity of disease assessment using Acute Physiology and Chronic Health Evaluation version II (APACHE II) score.
• Organ failure assessment using Organ Failure Assessment (SOFA) score and quick (SOFA) score.
• Kidney assessment using Kidney Disease Improving Global Outcomes (KDIGO) criteria.
• Liver disease assessment using Child-Pugh Score.
• Chest radiography, electrocardiography, and transthoracic echocardiography.
• Vital signs (systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate temperature, blood sugar level, and urine output).
• All patients will be monitored for the incidence of DVT, minor and major bleeding during their intensive care unit stay (ICU).
• Coagulation profile, serum lactate, serum electrolytes, hypoxic index,14-day mortality, and the following pro-inflammatory biomarkers will be measured at the start and at days 1,2, and 7 of the study.

i. CRP ii. Heparin-binding protein (HBP) iii. Plasminogen activator inhibitor (PAI).

• Patient demographic data will be recorded with respect to sex. age, weight, disease, and medication history.
• Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
• Results, conclusion, discussion, and recommendations will be given.
• A p-value of less than 0.05 will be considered statistically significant.
• The study data were evaluated using IBM SPSS software (statistical product and service solution version 26.0)

Inclusion criteria

• Adults Patients aged 18 years old or greatecritically ill patients aged 18-65 years diagnosed with sepsis/septic shock or developed sepsis/septic shock during their ICU length of stay were enrolled.

Exclusion criteria

-Thrombocytopenia, Intracerebral hemorrhage at the time of sepsis Bleeding tendency (INR ≥ 1.5 or PLT < 50 x 109/L,) Medical condition requiring therapeutic anticoagulation Age < 18 years Previous history of Heparin Induced Thrombocytopenia (HIT).