Plans to promote participant retention and complete follow-up {18b}
SECONDARY
Baseline symptom data will be collected from participants; testing, treatment, and outcome data will be extracted from the medical record. A 30-day (± 7 days) evaluation of renal function is required in the small subset of participants who have an elevated creatinine at the time of pathway termination in children who do not require RRT, to determine the MAKE30 primary outcome. This laboratory evaluation is considered standard of care and thus, no specific research follow-up is required.A participant will be considered lost to follow-up if a 30-day follow-up serum creatinine value is required to assign MAKE30 status, and none is performed as part of clinical care, or the result cannot be obtained. To minimize lost to follow-up, the following actions will be taken by the clinical care team if a participant fails to return to the clinic for the required follow-up:The clinic will attempt to contact the participant. If contact is made, the clinical care team will counsel the participant on the importance of serum creatinine monitoring. If the participant is unable or unwilling to attend the study site phlebotomy laboratory as directed, the site will provide an alternate, more convenient location for serum creatinine testing.If step 1 is unsuccessful, the research team will make every effort to regain contact with the participant, employing, where possible, up to 3 telephone calls and, if necessary, a certified letter to the participant’s last known mailing address or local equivalent methods. This contact will serve to reinforce the importance of clinical follow-up and we will re-connect the participant with the clinical care team.Non-adherence with the allocated fluid administration protocol by the clinical care team will not impact research data collection and study procedures; we will collect all primary and secondary outcomes data as well as AEs, SAEs, and unanticipated problems (UP) regardless of adherence status. Participants are free to withdraw from the study at any time thereby terminating further data collection. The reason for participant discontinuation or withdrawal will be recorded.