Assessment of Pleotropic Effect of Heparin Infusion Versus Subcutaneous Injection in Septic Shock Patients

Summary

Participation Requirements

Description

Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University. All participants or their next kin should agree to participate in this clinical study and will provide informed consent. 100 participants who are critically ill with septic shock. The 100 ...

Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University. All participants or their next kin should agree to participate in this clinical study and will provide informed consent. 100 participants who are critically ill with septic shock. The 100 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 time of enrollment to the following: Full patient history and clinical examination. complete blood picture, liver function tests, renal function tests. The initial cause of ICU admission and define the origin of 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,28-day mortality and the following pro inflammatory biomarkers will be measured at the start and at day 2 of the study. i. CRP ii. Heparin binding protein (HBP) iii. IL-6 iv. Neutrophil gelatinase -associated lipocalin (NGAL). v. Plasminogen activator inhibitor (PAI). Patients 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 significance. Statistical analysis will be performed by STATA/IC (version 16 for Windows); Stata Corp LP, College Station, TX.

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