An observational prospective cross-sectional study on extravascular lung water by lung ultrasound as a guide to fluid resuscitation therapy in adult septic shock in tertiary care hospital in central India

Aim

This study aims to evaluate the utility of extravascular lung water (EVLW) estimation by lung ultrasound in guiding fluid resuscitation therapy in adult patients with septic shock admitted to a rural tertiary care teaching hospital.

Primary objective

Secondary objectives

Study design

This study will employ an observational prospective cross-sectional design to assess the utility of extravascular lung water (EVLW) estimation by lung ultrasound in guiding fluid resuscitation therapy in adult patients with septic shock.

Study population

The study population will consist of adult patients admitted to the intensive care unit (ICU) of Acharya Vinoba Bhave Rural Hospital (AVBRH) with a diagnosis of septic shock. Patients meeting the inclusion criteria and not meeting the exclusion criteria will be eligible for enrollment in the study.

Inclusion criteria

Exclusion criteria

Place of study

The study will be conducted at Acharya Vinoba Bhave Rural Hospital (AVBRH), a tertiary care teaching hospital in Wardha District. AVBRH serves as a major healthcare facility for rural residents in central India. The study will specifically take place within the ICU of AVBRH, where critically ill patients, including those with septic shock, receive specialized care and management.

Data collection process

The data collection process for this study will involve systematic and standardized procedures to ensure the accuracy and reliability of the collected data. Trained research personnel will be responsible for conducting the data collection activities under the supervision of the principal investigator. At the outset, eligible patients meeting the inclusion criteria will be identified upon admission to the intensive care unit (ICU) at Acharya Vinoba Bhave Rural Hospital (AVBRH). Patients who fulfill the study criteria will be approached for participation, and informed consent will be obtained from the patient or their legally authorized representative.

Once consent is obtained, baseline demographic information, including age, sex, BMI, and past medical history, will be recorded. Clinical parameters such as blood pressure, heart rate, respiratory rate, and temperature will also be documented. Additionally, relevant comorbidities and risk factors will be noted for each participant. The primary outcome measure, extravascular lung water (EVLW), will be assessed using lung ultrasound by counting the number of B-lines. Trained ultrasound operators will perform the lung ultrasound examinations according to standardized protocols. The presence and severity of pulmonary edema will be determined based on the number of B-lines observed between rib spaces.

Following the initial assessment, fluid resuscitation therapy (FRT) will be initiated based on the presence and severity of EVLW detected by lung ultrasound. The type and dose of fluid therapy will be recorded, along with any adverse events or complications associated with the intervention. Subsequent lung ultrasound examinations will be conducted at predetermined time points (6, 12, 24, and 48 hours post-FRT initiation) to monitor changes in EVLW and assess treatment response. Clinical parameters, laboratory values (including serum creatinine levels and urine output), and vital signs will also be recorded each time.

Data integrity and quality will be ensured throughout the study period through regular monitoring and validation checks. The research team will promptly address and resolve any discrepancies or missing data. Confidentiality of patient information will be maintained at all times, with data stored securely in compliance with regulatory guidelines.

Sample size

During the study period, approximately patients with septic shock are expected to participate. The sample size calculation was based on a previously reported prevalence of sepsis and septic shock, which was found to be 42.6%. This is an estimated sample size of approximately 44 participants. The study will include patients diagnosed with septic shock admitted to the Intensive Care Unit (ICU) at the research site, adhering to predefined inclusion criteria to ensure relevance to the research objectives and sample homogeneity.

Statistical analysis

This study’s statistical methods encompass descriptive and inferential techniques to comprehensively analyze the collected data about extravascular lung water (EVLW) estimation and fluid resuscitation therapy (FRT) in patients with septic shock. Descriptive statistics will be employed initially to summarize baseline characteristics of the study population, encompassing demographic variables, clinical parameters, and comorbidities. Continuous variables such as age, BMI, and laboratory values will be summarized using measures of central tendency (mean, median) and dispersion (standard deviation, interquartile range). In contrast, categorical variables like sex and comorbidities will be presented as frequencies and percentages. Inferential statistics will then be applied, including repeated measures analysis of variance (ANOVA) to assess changes in mean PaO₂/FiO₂ ratios and other continuous variables over multiple time points post-FRT initiation. Chi-square analysis will be utilized to compare categorical variables such as ICU mortality rates and requirements for renal replacement therapy between different patient groups based on EVLW levels. Additionally, correlation analysis will explore associations between EVLW measured by lung ultrasound and relevant variables like serum creatinine levels and urine output. In contrast, survival analysis techniques such as Kaplan-Meier curves and Cox proportional hazards models may evaluate the association between EVLW and long-term outcomes. Regression analysis will further investigate predictors of outcomes such as fluid overload or the need for renal replacement therapy. A significance level of p < 0.05 will be considered statistically significant for all analyses, and results will be interpreted alongside measures of effect size and confidence intervals to ensure robust conclusions. Analysis will be conducted using appropriate software packages such as R Studio to facilitate accurate and reliable interpretation of findings.

Ethical considerations

The Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (DU) has granted its approval to the study protocol (Reference number: DMIHER (DU)/IEC/2022/297. Date: 21-07-2022). Before commencing the study, we will obtain written informed consent from all participants, providing them with a comprehensive explanation of the study’s objectives.

Dissemination

After the completion of the study, we will publish it in an indexed journal or conference.

Study status

The study has not yet started. After the publication of the protocol, we will start recruiting for the study.