Secondary outcomes
supportHUS, Thrombocytopenia, myocardial ischemia, Anemia, depressed, Bacteremia, AKI, Hyperglycemia, Ascites, Pancreatitis, Thrombotic or hemorrhagic stroke, Acute cholecystitis, Coma, loss of kidney function, hypotension, Seizures, Arrhythmias, Peritonitis, Pleural effusions, Death, Cardiopulmonary arrest, Respiratory failure, Myocarditis
THROMBOCYTOPENIA, MYOCARDIAL ISCHEMIA, ANEMIA, HYPERGLYCEMIA, INTUSSUSCEPTION, ASCITES, PANCREATITIS, MYOCARDIAL DYSFUNCTION, ACUTE CHOLECYSTITIS, COMA, INFECTIOUS, COMPLICATIONS, MYOCARDIAL INFARCTION, DISEASE, ARRHYTHMIAS, MYOCARDIAL INFARCTION, PERITONITIS, PLEURAL EFFUSIONS, CARDIOPULMONARY ARREST, RESPIRATORY FAILURE, MYOCARDITIS
These will focus on quantifying other measures of efficacy and safety. They have been selected to provide supportive information about the effect of volume expansion on the primary outcome and the natural history of disease (see Table OutcomesMAKE30 is defined as:1) Death due to any cause censored at 30 days after enrollment OR2) Provision of RRT, any modality, within 30 days of trial enrollment OR3) Sustained loss of kidney function (100% increase of serum creatinine from baseline at 30 ± 7 days)Baseline serum creatinine: eGFR (120 ml/min/1.73m30-day serum creatinine: these will only be required for participants with an elevated value at the time of fluid pathway termination who do not receive RRTa. Neurologici. Seizures requiring anticonvulsant therapyii. Coma: depressed mental state requiring mechanical ventilation for airway protection and/or ventilatory supportiii. Thrombotic or hemorrhagic stroke confirmed by neuroimagingb. Cardiaci. Myocardial infarction: elevated troponin and electrocardiographic features of myocardial ischemia with cardiologist assignment of myocardial infarctionii. Myocarditis: elevated troponin along with cardiologist assigned diagnosis of myocarditisiii. Myocardial dysfunction: reduced ejection fraction requiring inotropic agentsiv. Cardiopulmonary arrest requiring cardiopulmonary resuscitation and/or extracorporeal membrane oxygenationv. Arrhythmias requiring electrical or chemical cardioversion or pharmacological anti-arrhythmic therapyc. Respiratoryi. Respiratory failure requiring invasive mechanical ventilation (i.e., via an endotracheal tube)ii. Pleural effusions requiring thoracostomy or thoracentesisd. Gastrointestinali. Hyperglycemia requiring insulin therapy at time of hospital dischargeii. Bowel obstruction/perforation requiring surgical repairiii. Intussusception requiring reductioniv. Acute cholecystitis requiring decompressionv. Pancreatitis with lipase > 3.0 × upper limit of normal (ULN) for agevi. Hepatitis/liver failure when any one of the following biochemical criteria are met: bilirubin (when other liver functions are in the normal range) > 3.0 × ULN; bilirubin (when accompanied by any increase in other liver function test) > 1.75 × ULN; AST, ALT, and GGT > 8 × ULNvii. Ascites requiring paracentesisa. Infectious complicationsi. Bacteremia with or without hypotension requiring inotropic supportii. Peritonitis with or without hypotension requiring inotropic supportHUS is defined as [1) Anemia (hematocrit level < 30%) AND2) Thrombocytopenia (platelet count < 150 × 103) AKI (serum creatinine concentration > upper limit of reference range for age)