Thesis protocol : Outcomes of patients with HYPOALBUMINEMIA, their associated comorbidities AND their OUTCOMES

Title : Outcomes of patients with HYPOALBUMINEMIA, their associated comorbidities AND their OUTCOMES 

Introduction :

Hypoalbuminemia is a medical sign in which the level of albumin in the blood is low. This can be due to decreased production in the liver, increased loss in the gastrointestinal tract or kidneys, increased use in the body, or abnormal distribution between body compartments. Patients often present with hypoalbuminemia as a result of another disease process such as malnutrition as a result of severe anorexia nervosa, sepsis, cirrhosis in the liver , nephrotic syndrome in the kidneys, or protein losing enteropathy in the gastro intestinal tract. (ref) 

Problem statement :

"Three theoretical constructs drive current collective  medical cognition around the relationship between hypoalbuminemia and comorbidities and outcomes. 

First, albumin might serve as a nutritional marker, such that hypoalbuminemia represents poor nutritional status in patients who go on to experience poor  outcomes. 

Second, albumin has its own pharmacologic characteristics as an antioxidant or transporter, and therefore, the lack of albumin might result in a deficiency of those functions, resulting in poor patient outcomes. 

Or third, albumin is known to be a negative acute phase protein, and as such hypoalbuminemia might represent an increased inflammatory status of the patient, potentially leading to poor outcomes. 

A thorough review of the literature reveals the fallacy of these arguments and fails to show a direct cause and effect between low albumin levels per se and adverse outcomes. Interventions designed solely to correct preoperative hypoalbuminemia, in particular intravenous albumin infusion, do little to change the patient's course of hospitalization." (Entirely quoted from ref 1)

Also there are very few studies available that have evaluated the diagnostic and therapeutic event factors  which influence the comorbidities in patients with hypoalbuminemia (ref number 1) and our study aims to bridge this gap.

Ref 1 : https://journals.sagepub.com/doi/abs/10.1177/000313481708301123?journalCode=asua

Aim

To Learn About  Factors Influencing the  Clinical Profile and Comorbidities in the Development of Hypoalbuminemia and It's outcomes and correlating team  learning outcomes with patient improvement outcomes 

Objectives :

1) To collect and document hypoalbuminemia patient illness event data reflecting their morbidities and comorbidities in their individual historical timeline.

2)To match collected individual particular patient event data with past  generalizable data around hypoalbuminemia 

3)To evaluate each thematic category of hypoalbuminemia patient event data into diagnostically labeled morbidities as well as comorbidities and establish a relation between their intervention outcomes over time

4) To synthesise new learning outcomes over what is currently available and documented globally for patients with hypoalbuminemia and establish the relationship, if any, between the newly synthesized learning outcomes from each hypoalbuminemia patient participant and their or their subsequent hypoalbuminemia patient's healing outcomes.

MATERIALS AND METHODS :

STUDY DESIGN :

Qualitative, Prospective and Observational study that evaluates each thematic category of patient illness event data into diagnostically labeled morbidities as well as comorbidities and establishes a relation between their intervention outcomes over time

METHODOLOGY : 

1) Patients having low serum albumin are selected from CASUALTY, OPD, IPD  in ... Institute of Medical Sciences

2) Consent is taken for study participantion as well as deidentified data sharing from the patient and their advocates/relatives after explaining the potential harms and benefits along with need for further follow up. 

Sample informed Consent forms:

1) For deidentified case reporting 

https://medicinedepartment.blogspot.com/2020/05/informed-patient-consent-and.html?m=1

2) Patient information sheet :

English:

https://drive.google.com/file/d/12LLDgFBVfnTxDdNv5K715uSyLYPUEgrY/view?usp=drivesdk

Telugu:

https://drive.google.com/file/d/13Df9wCu9zhjECpPxcHEULSAphv6-tDHl/view?usp=drivesdk

Template of this "patient information sheet" is borrowed from👇

https://www.ncbi.nlm.nih.gov/books/NBK261334/

And modified according to the thesis topic.

CONSENT FORMS

https://docs.google.com/presentation/d/1dWNeHi6nSgfqbrFV3jmP6R15gasZrGHD/edit?usp=drivesdk&ouid=109331939192934520503&rtpof=true&sd=true

More here : https://vamsikrishna1996.blogspot.com/2020/10/thesis.html?m=1

3) Methodology of data collection and analysis illustrated through a Sample case report form to demonstrate thesis objectives:

Please see this sample case report form/proforma (collected and suitably archived albeit semistructured case data):

Thesis participant is a 50M Hypoalbuminemia, Viral thrombocytopenia comorbidities Diabetes 10 yrs CAD CCF 

https://chat.whatsapp.com/J73wQ60iSov7c30Xhi7hRV

Demonstration of thematic analysis and objectively structured clinical evaluation(OSCE) data extraction process from the above single case report proforma in line with the objectives below :

1) To collect and document hypoalbuminemia patient illness event data reflecting their morbidities and comorbidities in their individual historical timeline.

Morbidities : 

Fever 3 days 

Body pain 3 days 

Shortness of breath 1 day

Subsequently :

Hypotension 

Severe thrombocytopenia 

Impression: Viral fever with thrombocytopenia, hypoalbuminemia 

Comorbidities :

Trunkal obesity 

Diabetes 10 years 

Hypertension 1 year 

CAD 

CCF 

Renal failure AKI on CKD 

Albuminuria 

Hypoalbuminemia 

Diagnostic and therapeutic Outcome interventions :

Diagnostic:

Fever pattern monitoring 

Platelet monitoring 

Vitals and Respiratory parameters monitoring 

Urine output monitoring 

Therapeutic :

For thrombocytopenia : platelets 

For hypotension :  iv vasopressors 

Hypoxia : adjusted fio2

Diabetes : Insulin short acting 

CCF : iv loop diuretics 

AKI : conservative 

2)To match collected individual particular patient event data with past  generalizable data around cardiac arrhythmias and associated comorbidities and their outcomes 

The above patient data was matched to past available data around similar clinical scenarios with similar hypoalbuminemia and comorbidities and following learning themes emerged that needed to be pursued further:

Diagnostic uncertainties:

Hypoalbuminemia in this 50M with Diabetes, CAD, CCF, AKI, CKD, albuminuria and a recent fever with thrombocytopenia can be due to:

Diabetic nephropathy glomerular injury or even a recent onset non diabetic kidney disease due to acute glomerular injury 

Negative acute phase reactant 

Liver failure 

Unlikely malnutrition or malabsorption 

Therapeutic uncertainties :

Role of platelet therapy 

Role of albumin therapy 

Absence of afterload reducing agents for his left heart failure management 

Role of indiscriminate antibiotics in  absence of definite  microbiological drivers 

 Role of CAD prophylactic agents and their stopping in indirectly precipitating the current outcomes of arrhythmias 

3)To evaluate each thematic category of hypoalbuminemia patient event data into diagnostically labeled morbidities as well as comorbidities and establish a relation between their intervention outcomes over time

The patient timeline that is usually displayed daywise in a single fever chart along with soap notes is currently missing from the above sample case report proforma and hence this third objective is not met at this point of time  

4) To synthesise new learning outcomes over what is currently available and documented globally for patients with hypoalbuminemia and establish the relationship, if any, between the newly synthesized learning outcomes from each hypoalbuminemia patient participant and their or their subsequent patient's healing outcomes.

From the above diagnostic and therapeutic uncertainty themes extracted from the single sample case report form and on review of literature of existing knowledge around these, it's clear that  more research using similar clinically complex patient data is needed to synthesize information over what is currently available. In this given individual patient the hypoalbuminemia appears to appears to have multiple influences, namely: a 

Diabetic nephropathy glomerular injury or even a recent onset non diabetic kidney disease due to acute glomerular injury or as a negative acute phase reactant due to the recent viral fever or due to liver failure again due to the acute febrile inflammatory illness and his outcomes needs to be gathered meticulously over time using currently available "medical cognition" tools.