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Table 4 Parameters recorded in the study case report form

From: SaMpling Antibiotics in Renal Replacement Therapy (SMARRT): an observational pharmacokinetic study in critically ill patients

Admission details

• Patient characteristics (identification number, age, sex)

• Inclusion and exclusion criteria

• Consent details

• Co-enrolment

• Date of hospital admission

• Patient’s height and weight

• Admission diagnosis

• Date of ICU admission

• APACHE II score on ICU admission

Clinical details

• Site of infection

• Identification of pathogen(s) and susceptibility to study antibiotic

• SOFA score (ICU admission, and sampling occasions 1 and 2)

• Cumulative fluid balance

• Medication details (antibiotic(s), dose administered, dosing intervals)

• Clinical response

Renal Replacement Therapy

• Modality

• Filter membrane size

• Filter membrane material

• Transmembrane pressure

• Replacement fluid flow rate (pre/post dilution)

• Dialysate fluid flow rate

• Targeted hourly fluid removal rate

Laboratory Investigations

• Blood sampling time

• Measured effluent volume at pre-defined collection time

• Effluent sampling time

• Residual measured urinary creatinine clearance

• Residual urine sampling time

• Haematocrit

• Liver function tests

Completion and outcome details

• Reason for discontinuation/withdrawal

• Reason for protocol deviation/violation

• Adverse events

• Vital status at ICU and hospital discharge

• 28 day survival

 
  1. Abbreviations: ICU Intensive care unit, APACHE Acute Physiology and Chronic Health Evaluation, SOFA Sequential Organ Failure Assessment Score