Here is the design of a clinical trial:

Official Title: Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis

Included conditions:
- Shock
- Septic

Study Armgroups:
- {'label': 'Balanced fluids (BF)', 'type': 'EXPERIMENTAL', 'description': "Balanced fluids (BF), including Lactated Ringer's and Plasma-Lyte (PL), will be administered to patients randomized to the experimental arm. BF will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calendar day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.", 'interventionNames': ['Drug: Lactated Ringer', 'Drug: Plasma-lyte']}
- {'label': '0.9% "Normal" Saline Fluid (NS)', 'type': 'ACTIVE_COMPARATOR', 'description': '0.9% "normal" saline (NS) fluid will be administered to patients randomized to the active comparator (control) arm. NS will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calendar day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.', 'interventionNames': ['Drug: Normal Saline']}

Interventions:
- {'type': 'DRUG', 'name': 'Lactated Ringer', 'description': 'LR is a sterile, nonpyrogenic "balanced" solution used for fluid and electrolyte replenishment via intravenous or intraosseous administration. Each 100 mL of LR contains 600 mg sodium chloride (NaCl), 310 mg of sodium lactate (C3H5NaO3), 30 mg of potassium chloride (KCl), and 20 mg of calcium chloride (CaCl2 · 2H20) with an approximate potential of hydrogen (pH) of 6.5 (6.0 to 7.5).', 'armGroupLabels': ['Balanced fluids (BF)'], 'otherNames': ['LR']}
- {'type': 'DRUG', 'name': 'Normal Saline', 'description': 'Normal saline solution is an "unbalanced" crystalloid solution containing 154 mEq/L of sodium and 154 milliequivalent (mEq/L) of chloride.', 'armGroupLabels': ['0.9% "Normal" Saline Fluid (NS)'], 'otherNames': ['0.9% Saline', 'NS']}
- {'type': 'DRUG', 'name': 'Plasma-lyte', 'description': 'PL is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration. Each 100 mL contains 526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C6H11NaO7); 368 mg of Sodium Acetate Trihydrate, USP (C2H3NaO2•3H2O); 37 mg of Potassium Chloride, USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl2•6H2O). It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide. The pH is 7.4 (6.5 to 8.0).', 'armGroupLabels': ['Balanced fluids (BF)'], 'otherNames': ['PL']}

Primary Outcomes:
- {'measure': 'Proportion of participants with Major Adverse Kidney Events within 30 days (MAKE30)', 'description': 'A composite of death, initiation of new inpatient renal replacement therapy (RRT), or persistent kidney dysfunction, at 30 days following study enrollment or hospital discharge, whichever comes first.', 'timeFrame': 'Between randomization and 30 days post enrollment, discharge or death, whichever comes first.'}

Please estimate the sample size based on the assumption: 
The study assumes a significance level (type I error) of 0.05, a power of 95% for the primary endpoint, and an 84% power to detect a decrease in mortality from 3% to 2%. It also assumes >99% power to detect a 1-day reduction in hospital-free days.
Sample size
        A baseline incidence of MAKE30 in children with septic shock predominantly resuscitated with 0.9% saline was determined based on a prior pediatric study (9.6% MAKE30) [39], the proportion of patients aged 18â21âyears enrolled in the SMART trial (9.7% MAKE30) [17], and institutional registry data from two US study sites (5.0% and 7.8% MAKE30). We anticipate a conservative MAKE30 incidence of 6% among children treated in an ED for suspected septic shock largely resuscitated with 0.9% saline. Enrollment of 8800 total participants will provide 95% power to detect an absolute risk reduction (ARR) in MAKE30 from 6.0% for children treated with 0.9% saline to 4.3% for balanced/buffered fluids with a standard type I error of 0.05. This ARR corresponds to the 28% relative risk reduction in MAKE30 observed in the youngest subset of patients (18â21âyears) enrolled in SMART. Due to the small anticipated ARR with potential for type II error, we purposely selected a high power of 95% for the primary endpoint. This sample size will also provide 84% power to detect a decrease in mortality from 3% with saline to 2% with balanced/buffered fluids and >â99% power to detect a 1-day reduction in hospital-free days.
        Recruitment of this large sample size requires collaboration across >â40 sites from three research networks. Based on the enrollment of 85% of eligible patients in our pilot study [25], sites are anticipated to enroll >â80% of eligible patients. Recruitment will be monitored, with targeted support provided to sites that consistently fall below this target. Targeted support will include local investigators meeting with the lead investigators from their respective networks to review the process for screening, determination of eligibility criteria, education of local emergency clinicians who assess for eligibility, location of enrollment materials relative to patient care in the emergency department, and tracking of reasons for missed enrollments. If enrollment fails to demonstrate improvement toward or above the >â80% target despite these efforts, the site will be considered for removal from study participation and a replacement site will be identified.