Trial treatment details, and adherence
No formal statistical testing will be performed.
Crossover Any participant who receives the intervention from the arm they were not allocated to within 24 hours of randomisation will be defined as a crossover and does not need to be recorded as a deviation.
Non-adherence This will be defined as to have occurred in any participant who has not received their allocated fluid prescription for resuscitation within 6 hours of the randomisation and does not need to be recorded as a deviation.
Table: Per treatment group, who received their allocated fluid for resuscitation within hours, a table showing the following:
a) Yes, within 75% of that allocated and did not cross over within 0 to 6 hours
b) Yes, within 75% of that allocated and did cross over within 0 to 6 hours
c) Yes, at least 200mls administered, regardless of whether crossover occurred
d) Some received but between 6 hours and less than 12 hours, regardless of whether crossover occurred
e) Some received but between 12 and less than 24 hours, regardless of whether crossover occurred
f) None received or unknown.
Graph: The cumulative distribution function for each of volume and % of allocated resuscitation fluid received, by treatment group, will be plotted separately for each of the time windows 0-6 hours; 0-12 hours; 0-24 hours; 6-24 hours.
Graph: Kaplan-Meier curves will be plotted, by treatment group, for time to crossover.
Further, adherence per treatment group will summarised descriptively using the following measures:
1) Time to start of IMP (randomisation to treatment)
2) Proportion of patients who received their allocated intervention for fluid resuscitation
3) Proportion of patients who received their allocated intervention for maintenance
4) Proportion of patients who received crossover fluid in to 6 hours and volume of crossover fluid received
5) Proportion of patients who received crossover fluid in to 24 hours and volume of crossover fluid received
6) Completion rates for initial bolus administration (within first 6 hours)
7) Proportion of patients who receive any other fluid apart from intervention or control during first 6 hours.