ISSN: 2320-5407 Int. J. Adv. Res.

12(02), 265-271

Journal Homepage: - www.journalijar.com

Article DOI: 10.21474/IJAR01/18291

DOI URL: http://dx.doi.org/10.21474/IJAR01/18291

RESEARCH ARTICLE
CLINICAL OBSERVATION OF TREATMENT EFFICACY IN SEPSIS: A PROSPECTIVE STUDY

Mir Mansoor Sultan1, Adeeba Younus2, Durre Shahwar Fatima2, Faria Mushtaq2 and Dr. Salma Tasneem3
1. Assistant Professor, Department of Pharmacology, Sultan-Ul-Uloom College of Pharmacy, Banjara Hills,
Hyderabad-500034, Telangana, India.
2. Students, Department of Pharmacology, Sultan-Ul-Uloom College of Pharmacy, Banjara Hills, Hyderabad-
500034, Telangana, India.
3. Clinical Pharmacist, Princess DurruShehvarChildrensAnd General Hospital, Purani Haveli, Hyderabad-500002,
Telangana, India.
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Manuscript Info Abstract
……………………. ………………………………………………………………
Manuscript History Objective: To examine the safety and efficacy associated with various
Received: 15 December 2023 treatment approaches and to identify trends and variations in the
Final Accepted: 18 January 2024 management of severe sepsis, including the usage of antibiotics, and
Published: February 2024 supportive care. To examine factors associated with improved or
worsened outcomes in severe sepsis cases, such as patient
Key words:-
Severe Sepsis, Antibiotics, Prospective demographics, comorbidities, or timing of treatment.
Study, Meropenem, Treatment Efficacy, Design: A hospital-based prospective study was done on all inpatients
Culture Sensitivity, Patient-Centered and outpatients in Princess DurruShehvar Children's & General
Methods, Statistical Methodologies,
Hospital, Hyderabad, Telangana for 6 months.
Real-World Effectiveness, Clinical
Complexity Methods: The data collection form and patient consent form were
designed for this study. It comprises information regarding the study
subject's data such as demographics, medical and medication history,
laboratory investigations, diagnosis, present prescribed medication, and
progress chart. Investigators collected the relevant data and recorded it
in data collection form. The prescription will be selected based on
inclusion criteria and exclusion criteria. The data obtained was
compiled and analysed using appropriate statistical tests. Quantitative
variables were summarized using descriptive studies (percentages,
mean, standard deviation, number of observations). The data was
statistically analyzed using spss and pair t test, graphs, pie diagrams,
and bar graphs.
Results A total of 115 patients were included in this prospective study
and 60% of them show culture sensitivity. Meropenem was found to be
the most potent antibiotic. The analysis of the treatment’s impact
reveals noteworthy outcomes across multiple parameters. The
intervention demonstrates a significant effect in reducing systolic blood
pressure, although no major influence on diastolic blood pressure is
observed. Regarding erythrocyte sedimentation rate (ESR), a
substantial and statistically significant decrease is indicated post-
treatment. Notably, arterial blood gas (ABG) levels exhibit a
considerable difference pre- and post-treatment, with a p-value below
0.05, suggesting a rejection of the null hypothesis. Additionally, the
treatment is associated with a significant increase in total leukocyte

Corresponding Author:- Mir Mansoor Sultan 265

Address:- Assistant Professor, Department of Pharmacology, Sultan-Ul-Uloom
College of Pharmacy, Banjara Hills, Hyderabad-500034, Telangana, India.
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counts, as evidenced by the positive mean difference and a 95%

confidence interval entirely above zero. These findings underscore the
diverse impacts of the treatment on various physiological markers.
Conclusion Prospective sepsis treatment studies offer a nuanced grasp
of real-world effectiveness, linking controlled experiments to clinical
reality. Despite biases, they contribute to evidence-based strategies,
acknowledging clinical complexities. This practical approach guides
healthcare professionals with adaptable, patient-centered methods.
Emphasis on rigorous statistical methodologies enhances
comprehension. Integrating observational and experimental data
enriches our understanding of sepsis management. Overall, these
studies shape holistic approaches for effective treatment.

Copy Right, IJAR, 2024,. All rights reserved.

……………………………………………………………………………………………………....
Introduction:-
Sepsis is a life-threatening condition caused by the body's extreme response to an infection. This heightened
response can lead to organ damage, and individuals of advanced age, infants, or those Individuals with pre-existing
health conditions are particularly susceptible. While bacteria are the primary cause of infection, other pathogens
such as viruses or fungi can also trigger infection or septicemia. Clinically, Septicemia is divided into 3 stages, with
key diagnostic criteria including alterations in mental status, increased respiratory rate, and decreased blood
pressure. Notably, sepsis itself is not contagious. Treatment typically involves hospitalization, intravenous
antibiotics, and supportive measures to address organ failure. [1] [2] [3] [8]

The presence of Gram-positive cocci and Gram-negative bacilli bacteria in the blood heightens the likelihood of
progressing to severe sepsis or septic shock within the first month in the ICU. Moreover, the timing of sepsis
diagnosis impacts survival rates, with individuals initially clinically diagnosed with septic shock having an elevated
risk of mortality within 28 days (about 4 weeks). Progression to severe sepsis and/or septic shock during the first
week further increases the probability of mortality. [4]

Urosepsis and septic shock were the common types detected along with LRTI /UTI Sepsis. Antibiotics are the first
line of defense against urosepsis and must be administered quickly and quickly to eliminate the bacteria that causes
the infection. [3]

The main objective of the study was to examine the safety and efficacy associated with various treatment
approaches. Identify trends and variations in the management of severe sepsis, including the usage of antibiotics,
and supportive care and to examine factors associated with improved or worsened outcomes in severe sepsis cases,
such as patient demographics, comorbidities, or timing of treatment. [5] [6] [7]

Methodology:-
Design And Duration Of Study:
A hospital-based prospective study was done on all inpatients and outpatients in Princess DurruShehvar Children's
& General Hospital, Hyderabad,

Telangana for a period of 6 months.

Study Population:
The individuals who are diagnosed with sepsis and are being given antibiotics were considered. The sample size was
115.

Study Method/ Study Procedure/ Methods Of Data Collection:

Permission will be taken by higher authorities to obtain the data. The data collection form and patient consent form
were designed for this study. It comprises information regarding the study subject's data such as demographics,
medical and medication history, laboratory investigations, diagnosis, present prescribed medication, and progress

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chart. Investigators collected the relevant data and recorded it in data collection form. The prescription was selected
based on inclusion criteria and exclusion criteria.

Statistical Analysis
The data obtained was compiled and analysed using appropriate statistical tests. Quantitative variables were
summarized using descriptive studies (percentages, mean, standard deviation, number of observations). The data
was statisticallyanalysed using spss and pair t test, graphs, pie diagrams, and bar graphs. Comparison was done for
parameters such as total leukocyte count, platelet count, BP, PR, RR, ESR, etc. which gave results that showed the
impact of treatment on septic condition.

Results:-
Types of sepsis:
A total of 115 patients were identified with septic shock, sepsis, urosepsis and LRTI /UTI sepsis. Sepsis was found
in most of the individuals (60 patients), urosepsis (29 patients), LRTI/UTI Sepsis (55 patients) and septic shock
being the least (22 patients). Table 1.

Types of microorganisms:
The study involved the assessment of various microorganisms, and their respective percentages indicate the
distribution among 115 cases. Notably, Escherichia coli (E. coli) constituted 15.7%, Enterococcus 7.8%, Klebsiella
13.0%, Proteus 6.1%, Pseudomonas aeruginosa 6.1%, Staphylococcus aureus 20.9%, Staphylococcus pneumonia
0.9%, Streptococcus pneumoniae 16.5%, Streptococcus pyogenes 12.2%, and another instance of Staphylococcus
aureus at 0.9%. The total sums up to 100%. These findings serve as a foundation for evaluating the impact of the
treatment on the diverse microbial composition observed in the study. Further analysis can delve into changes in
specific microorganism counts and their responses to the treatment. Table

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Culture sensitivity test:

In the study involving 115 sepsis patients, approximately 60% (69 patients) demonstrated culture sensitivity. This
indicates a substantial portion of the patient population that exhibited responsiveness to the tested antimicrobial
agents. Table 3.

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Antibiotics Used In Treatment:

Antibiotics are considered as first line treatment for sepsis which are administered to eradicate the bacteria causing
infection. The variety of prescribed antibiotics suggests a comprehensive approach, targeting different types of
bacteria and infections.

The high count of Meropenem may indicate its effectiveness against a wide range of pathogens, and its application
in complex or severe cases.

Combination antibiotics like Cefepime and Tazobactam, Cefoperazone

And sulbactam, and Piperacillin and Tazobactam are prescribed, indicating a strategy to cover a wide range of
potential pathogens.

The presence of antibiotics like Doxycycline, Azithromycin, and

Amoxicillin and Potassium Clavulanate suggests consideration for some types of infections, like those that affect
the skin, soft tissues, or the respiratory system.

Table 4:-

Discharge Medication:
Upon discharge, a tailored medication plan was instituted for the 115 sepsis patients, reflecting a personalized
approach to treatment. Approximately 60% of these individuals exhibited culture sensitivity, influencing the
prescription of targeted antimicrobial agents. The discharge medications encompassed specific antibiotics based on
the identified microbial responses, addressing the diverse microorganism profiles observed in the study. Table 5

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Paired T-test
Paired T-test For Blood Pressure:
The treatment appears to have a significant effect on reducing systolic blood pressure, but no significant effect on
diastolic blood pressure based on the given data.

Paired T-test For Esr:

The results suggest that there is a significant difference between ESR before and after treatment. The positive mean
difference and the 95% confidence interval being entirely above zero indicate that the treatment is associated with a
statistically significant decrease in ESR.

Paired T-Test forAbg:

The results suggest that there is a large difference between ABG levels before and after treatment. The p-value is
lower than the common significance level of 0.05, indicating that we pass to reject the null hypothesis.

Paired Samples Correlations

N Correlation Sig.
Pair 1 ABG before treatment & ABG after 115 .120 .201
treatment

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Paired T-Test For Total Leukocytes:

The results suggest that there is a significant difference between total leukocyte counts before and after treatment.
The positive mean difference and the 95% confidence interval being entirely above zero indicate that the treatment
is associated with a statistically significant increase in total leukocyte counts.

Discussion:-
In our discussion, our prospective study provided valuable direct insights into the effectiveness of sepsis treatment,
offering real-world context and practical implications for clinicians through active observation and measurement of
treatment outcomes. In contrast, the referenced topic review by Gregory A Schmidt and Jess Mandel presented a
broader perspective on sepsis management, establishing general principles, approaches, and overarching strategies.
The review, aligning with the 2021 Surviving Sepsis Campaign guidelines, emphasized the critical role of early
blood cultures, a sentiment reinforced by a multicenter randomized trial highlighting the sensitivity of post-
antimicrobial blood cultures. This synthesis of direct observation and established principles contributes to a more
holistic understanding of effective sepsis management.

Conclusion:-
In summary, the evaluation of sepsis treatments through prospective studies offers a nuanced understanding of their
real-world effectiveness, considering diverse patient demographics and uncontrolled variables. This practical
approach, despite potential biases, serves as a crucial link between controlled experiments and the complexities of
everyday clinical practice. The knowledge gained from these investigations contributes to evidence-based and
patient-centered treatment strategies, recognizing the intricacies of sepsis management. While emphasizing the need
for rigorous statistical methodologies, the integration of observational and experimental data enriches our
comprehension, guiding healthcare professionals toward holistic and adaptable approaches in addressing the
complexities of sepsis treatment.

Bibliography:-
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https://www.who.int/news-room/fact-sheets/detail/sepsis
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