Relevant concomitant care permitted or prohibited during the trial {11d}
nephrotoxic
HYPOTONIC
We will permit the concomitant administration of all medications, supplements, complementary and alternative therapies, treatments, and/or procedures as deemed necessary by the responsible treating physicians. The study will not supply or recommend any specific rescue medication. As part of the overall site education strategies, we will discourage the use of antibiotics, opioids, antimotility agents, and nephrotoxic agents such as non-steroidal anti-inflammatory drugs. We will discourage the use of hypotonic intravenous fluids and will recommend balanced solutions instead of 0.9% saline. However, as this is a pragmatic embedded clinical trial, the treating clinicians, with input from patients and guardians will be responsible to make all treatment decisions.All relevant data will be extracted daily during chart reviews to enable clarification and confirmation in real-time, if required, and will include concomitant medications administered during the patient’s current illness and any antibiotics taken in the past 14 days. By collecting this information and incorporating it into study analyses, we will be able to identify the independent effects of administered concomitant medications and study interventions.