About this trial
The goal of this observational study is to learn whether hypoalbuminemia in post surgical patients receiving cefoperazone/sulbactam therapy poses them to the risk of developing coagulopathy. It will also study that what are the other risk factors for the development of cefoperazone/sulbactam induced coagulopathy. The main questions it aims to answer are : • Does hypoalbuminemia increase the risk of cefoperazone/sulbactam coagulopathy in post operative surgical patients?
* What is the incidence of cefoperazone/sulbactam induced coagulopathy in normoalbuminemic vs hypoalbuminemic patients. * Does renal function, nutritional status, dose and duration of therapy affect coagulopathy development? * What are the independent risk factors for the development of cefoperazone/sulbactam induced coagulopathy? Patients' coagulation tests will be followed during the duration of cefoperazone/sulbactam therapy to identify coagulation development.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients >= 18 years
Post-operative surgical patients
Receiving cefoperazone/sulbactam therapy for at least 72 hours.
Willing to give informed consent
Disqualifiers
Chronic liver disease
History of any inherited coagulation disorder
On anticoagulant therapy
Any massive blood loss requiring blood transfusion
Trial population
Patients will be enrolled from the Department Of General Surgery at Shaikh Zayed Hospital, Lahore who fulfill the eligibility criteria.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Coagulopathy Development in Hypoalbuminemic post operative surgical patients receiving cefoperazone/sulbactam
Development of coagulopathy ( any one of the following : INR \>1.5 , PT \> 25% from baseline, clinically significant bleeding due to coagulation disorder ) in hypoalbuminemic post operative surgical pateints receiving cefoperazone/sulbactam
Secondary outcomes
Incidence of cefoperazone/sulbactam induced coagulopathy in normoalbuminemic and hypoalbuminemic patients
I will compare the incidence of coagulopathy in hypoalbuminemic and normoalbuminemic post operative surgical pateints receiving cefoperazone /sulbactam and will give values in percentages
Association between renal function and nutritional status on cefoperazone/sulbactam induced coagulopathy development
I will study if abnormal renal function ( eGFR \< 60 mL/min/1.73m2 ) and poor nutritional status ( assessed using the NRS-2002 scale ) have any affect on the development of cefoperazone/sulbactam induced coagulopathy
Cumulative dose ( in grams ) of cefoperazone/sulbactam and the development of coagulopathy
It will be studied that what is the cut-off cumulative dose ( in grams ) of cefoperazone/sulbactam that is associated with the development of coagulopathy.
To identify independent predictors of coagulopathy among post-surgical patients receiving cefoperazone/sulbactam by performing multivariable logistic regression
To identify independent predictors of coagulopathy among post-surgical patients receiving cefoperazone/sulbactam by performing multivariable logistic regression analysis including hypoalbuminemia, renal function, nutritional status, dose, duration of therapy, and other clinically relevant confounding factors.
Locations
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