Impact of Hypoalbuminemia on Cefoperazone/Sulbactam Induced Coagulopathy in Post-Operative Surgical Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSheikh Zayed Federal Postgraduate Medical Institute

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

108 Participants
are grouped into 2 trial groups
Group A: The first group will be of normoalbuminemic post surgical patients receiving cefoperazone/sulbactam
Group B: The second group will be of hypoalbuminemic post surgical patients receiving cefoperazone/sulbactam

Trial outcomes

Primary outcomes

1

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

Time frame
From the start of cefoperazone/sulbactam therapy after surgery till the completion of therapy with cefoperazone/sulbactam i.e atleast 72 hours/3days

Secondary outcomes

1

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

Time frame
From enrollment through study completion, an average of 6 months.
2

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

Time frame
From the start of cefoperazone/sulbactam therapy after surgery till the completion of therapy with cefoperazone/sulbactam i.e atleast 72 hours/3days
3

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.

Time frame
From the start of cefoperazone/sulbactam therapy after surgery till the completion of therapy with cefoperazone/sulbactam i.e atleast 72 hours/3days
4

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.

Time frame
From the start of cefoperazone/sulbactam therapy after surgery till the completion of therapy with cefoperazone/sulbactam i.e atleast 72 hours/3days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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