A prospective observational study of red cell distribution width (RDW) as an outcome marker in Critically ill children admitted to a Pediatric Intensive Care Unit in a tertiary care hospital in central India

1. To evaluate RDW as a predictor of morbidity in critically ill children.

2. To assess RDW as a predictor of mortality in critically ill children.

3. To compare the predictive value of RDW with Pediatric Sequential Organ Failure Assessment (pSOFA) and Pediatric Logistic Organ Dysfunction 2 (PELOD2) scores in predicting the outcome of patients in the PICU.

1. Critically ill children aged between 1 month to 18 years.

2. Admitted to the Pediatric Intensive Care Unit (PICU).

3. PICU stays more than 24 hours.

1. Refusal of consent from the patient or guardian.

2. Admission for scheduled procedures that are typically managed outside the PICU.

3. PICU stay of less than 24 hours.

4. Patients with pre-existing hematological disorders.

5. Patients who have received a blood transfusion within the past seven days.

1. Selection bias: There will be a potential for selection bias in the study, as only critically ill children admitted to the Pediatric Intensive Care Unit (PICU) will be included. This may not represent the entire spectrum of pediatric patients, leading to a bias toward more severe cases.

2. Sampling bias: The study will use consecutive sampling, which may introduce bias if certain patients are systematically excluded or underrepresented during specific periods.

3. Information bias: Information bias could occur due to variations in data collection methods and interpretations of laboratory results, especially when multiple individuals are involved in data collection and recording.

1. Eligibility criteria: Patients who satisfy the predefined inclusion criteria, which include critically ill children aged between 1 month to 18 years and having Pediatric Intensive Care Unit (PICU) stays exceeding 24 hours, are eligible for enrollment in the study. This criterion-based approach is fundamental for maintaining the study’s relevance and applicability to the target population.

2. Informed consent: Enrollment into the study occurs only after obtaining written informed consent from the patient (if of an appropriate age and capacity) or from their legal guardians. This practice is essential for ensuring the ethical conduct of the research, respecting patient autonomy, and upholding the principles of informed and voluntary participation in medical research.

3. Consecutive sampling: To minimize the potential for selection bias and enhance the representativeness of the study population, consecutive sampling is employed. This systematic approach ensures that eligible patients are enrolled in the study continuously and unbiasedly throughout the two-year study period.

4. Data collection: Each patient undergoes a comprehensive data collection process once enrolled. This involves gathering detailed information, including demographic data, vital signs, specific diagnoses, results of laboratory tests, and the calculation of scores such as Pediatric Logistic Organ Dysfunction 2 (PELOD-2) and Sequential Organ Failure Assessment (SOFA). The data collected for each patient forms the basis for the subsequent Red Cell Distribution Width (RDW) analysis and its association with various outcome variables.

1. Demographic data: Detailed demographic information, including age, gender, and weight, will be meticulously recorded for each enrolled patient. This information will be fundamental for characterizing the study population and analyzing how RDW may relate to patient profiles.

2. Clinical assessment: Vital signs, such as heart rate, blood pressure, respiratory rate, and temperature, will be carefully monitored and documented. This clinical assessment will aid in understanding the patients’ overall health status upon admission to the PICU.

3. Diagnosis: The specific diagnosis or reason for admission to the PICU will be noted. This information will help categorize and analyze patient populations with different underlying conditions, which may affect the study’s outcomes.

4. Laboratory investigations: A comprehensive set of laboratory tests will be conducted, including a complete blood count, Red Cell Distribution Width (RDW), Kidney Function Test (KFT), Liver Function Test (LFT), C-reactive protein (CRP), and blood culture. These tests will provide valuable insights into the patients’ hematological and organ function status, as well as the presence of any infectious agents.

5. Additional investigations: Supplementary investigations, such as serum lactate and 2D echocardiography, will be performed when necessary to collect further clinical data relevant to the patient’s condition.

6. Scoring systems: The Pediatric Logistic Organ Dysfunction 2 (PELOD-2)⁵ and Sequential Organ Failure Assessment (SOFA)⁶ scores will be calculated within 24 hours of PICU admission. These scoring systems will be instrumental in assessing organ dysfunction’s severity and disease progression.

7. Outcome variables: Crucial outcome variables, including the length of ICU stay, the number of days of mechanical ventilation, ionotrope usage, the development of Acute Kidney Injury (AKI), the need for renal replacement therapy, and the outcome (death or discharge), will be meticulously documented.

1. Morbidity: This refers to being diseased or unhealthy. In the context of the study, researchers are interested in understanding how RDW is related to the morbidity or disease severity of critically ill children in the Pediatric Intensive Care Unit (PICU).

2. Mortality: In this context, mortality refers to death among critically ill children during their PICU stay. Researchers aim to investigate whether RDW can serve as a predictor of mortality in this population.

3. Length of ICU stay: This outcome variable measures each patient’s duration in the Pediatric Intensive Care Unit. Researchers seek to determine whether RDW is associated with longer or shorter ICU stays.

4. Mechanical ventilation days: This outcome assesses the number of days a patient requires mechanical ventilation during their stay in the PICU. Researchers aim to examine whether RDW is linked to a greater need for mechanical ventilation.

5. Ionotrope usage: Ionotropes are medications that support the heart’s function. Researchers will explore the relationship between RDW and the usage of ionotropes in critically ill children.

6. Acute Kidney Injury (AKI): This outcome focuses on developing acute kidney injury during the PICU stay. Researchers intend to investigate whether RDW is associated with a higher likelihood of AKI.

7. Renal Replacement Therapy: Researchers will assess if RDW is linked to the need for renal replacement therapy, a medical procedure to support kidney function in cases of severe renal dysfunction.

8. Outcome (Death or Discharge): This outcome variable categorizes patients into two groups: those who either succumb to their illness and pass away during their PICU stay or those who recover and are discharged. The study aims to determine if RDW can predict these outcomes.