Aim:  Study of Uric Acid as an early marker in predicting mortality and morbidity in patients with Sepsis

Objectives:

1.To estimate serum uric acid levels in patients of sepsis admitted in the critical care unit.

2.To correlate serum uric acid levels with duration of ICU stay, ventilatory management, multi organ dysfunction and mortality in critically ill patients in ICU.

Introduction: Sepsis is a critical medical condition characterized by a dysregulated host response to infection, often resulting in acute organ dysfunction. Early diagnosis and timely intervention are essential for improving outcomes in sepsis patients. This study protocol outlines a cross-sectional investigation into the potential prognostic value of serum uric acid levels in sepsis cases, aiming to contribute to the early identification and management of this life-threatening condition.

Methods: The study will be conducted at the Acharya Vinoba Bhave Rural Hospital, a tertiary care teaching hospital in Wardha District. Patients aged 18 years and above, diagnosed with sepsis or septic shock according to the Third International Consensus definition, will be included. Detailed clinical data will be collected, including comorbidities, vital signs, and organ dysfunction scores. Serum uric acid levels will be measured upon admission and at recovery from sepsis or seven days of non-recovery.

Method

Study Setting

This research will be conducted within the Acharya Vinoba Bhave Rural Hospital (AVBRH) Department of Medicine. AVBRH is a tertiary care teaching hospital in the rural Wardha District region. The commencement of the study will be contingent upon receiving approval from the Institute’s ethical committee, for which an application has been submitted.

Definition of the Case

Sepsis is characterized by a life-threatening dysfunction of vital organs resulting from an imbalanced host response to infection, as defined by the Third International Consensus [1]. The criteria for the development or onset of sepsis will adhere to established guidelines, precisely the ’Sepsis-3’ guidelines. Organ dysfunction in sepsis is identified by an acute alteration in the total Sequential Organ Failure Assessment (SOFA) score, consisting of 2 points or more, attributed to the effects of infections. A baseline SOFA score of zero can be assumed in patients without a known history of preexisting organ dysfunction. Notably, a SOFA score of 2 points or higher signifies an overall mortality risk of approximately 10% among individuals in a general hospital population suspected of having an infection. Even patients with relatively mild dysfunction can experience further deterioration, underscoring the gravity of this condition and the imperative for timely and suitable interventions, if not already initiated [1].

Inclusion Criteria

The study will encompass individuals aged 18 years and above who have received a sepsis or septic shock diagnosis per the defined criteria. These patients will be admitted under the Medicine Department at Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi.

Data Collection

History Taking: During the data collection process, comprehensive patient information will be obtained. This will include details such as age, gender, weight, the presence of co-morbidities (such as Diabetes Mellitus, Hypertension, Cardiovascular disease, Heart Failure, Chronic Obstructive Pulmonary Disease, renal failure, liver cell failure, and malignancy), and the likely etiology of the patient’s condition.

Thorough Clinical Examination: A rigorous clinical examination will be conducted to assess various aspects of the patient’s health. This examination will involve the evaluation of vital signs, including temperature, heart rate, respiratory rate, and mean arterial pressure (MAP) [12]. Additionally, the Glasgow Coma Scale (GCS) [13] will be employed to assess neurological status and a Quick Sequential Organ Failure Assessment (qSOFA) score, based on three parameters, will be calculated [14].

Laboratory Investigations: As part of the data collection process, peripheral venous blood specimens will be collected upon admission. These specimens will measure various parameters, including a Complete Blood Count (CBC), differential leucocytic count, and serum uric acid levels. The measurement of serum uric acid will be performed on both day 0 and day 7 of the patient’s hospitalization. This measurement will be carried out using an enzymatic colorimetric method facilitated by equipment from ROBONIK, a company certified under ISO 9001:2002 and ISO 13485:2003 standards. Specifically, the Automatic Biochemistry Analyzer with the model’s name Prietest ECO and serial number AC0090608RBK will be employed.

Sample Handling: To ensure the integrity of collected specimens, adequate venous blood samples will be withdrawn from patients. These samples will then be promptly subjected to centrifugation. Subsequently, serum specimens will be obtained and preserved under strict aseptic conditions. These specimens will be stored at a temperature of -20°C.

Normal Values: Establishing the normal reference values for serum uric acid levels in venous samples is essential. For males, the normal range is 3.4-7.2 mg/dL, while for females, it is 2.4-6.1 mg/dL.

Serum Uric Acid Levels: The study will measure serum uric acid levels at two distinct time points. The initial measurement will occur upon admission. Subsequently, a follow-up measurement will be conducted either at the point of recovery from sepsis or, in cases of non-recovery, after seven days from the onset of sepsis. These measurements will provide valuable data for the research objectives of the study.

Statistical Analysis

The statistical analysis will be conducted using a combination of descriptive and inferential statistics. Key statistical tests include the chi-square test and the student’s unpaired t-test. The software tools selected for data analysis are SPSS version 24.0 and GraphPad Prism version 7.0. Significance will be established at a p-value of less than 0.05, denoting the threshold for statistical significance. This rigorous statistical analysis will facilitate the extraction of meaningful insights from the collected data and contribute to the validity of the study’s findings.

Data availability

No data are associated with this article.

Competing interests

No competing interests were disclosed

Grant information

The authors declare that no grants were involved in supporting this work.

Expected outcomes: The primary outcome is assessing whether serum uric acid levels can be an early marker for sepsis diagnosis and prognosis. Secondary outcomes include evaluating the correlation between uric acid levels and mortality rates, organ dysfunction severity, inflammatory response, treatment response, and hospital length of stay. Additionally, the prognostic value of serum uric acid will be compared with established biomarkers for sepsis.