The study used a cluster cross over design to provide high quality data in a rapid time frame. Participating ICUs were randomly assigned to use either 0.9% saline or Plasma Lyte® 148 as the primary crystalloid fluid therapy in a blinded fashion in alternating 7 week blocks. Blinded study fluid was used for fluid therapy in situations where the two study fluids were regarded as clinically equivalent. All ICU Specialists in the study ICUs were consulted and agreed that on the basis of current evidence, 0.9% saline and Plasma Lyte® 148 are equally acceptable fluids for routine use.
Rather than randomising individual patients ICUs were randomised to use different routine intravenous fluids. Individual patients were not recruited into the study. Instead, any ICU patient who required crystalloid fluid therapy was included in the study by default. The method was … [loop 4 times – begin]Each of the 4 participating ICU’s was randomised to one arm of the study, at the end of 7 weeks each ICU switched to using the other arm fluids. [End loop]
Co-ordinated by the Medical Research Institute of New Zealand, in collaboration with the Australian and New Zealand Clinical Trials Group, the results of the trial was published in October 2015 in The Journal of the American Medical Association.
We used our standard eCRF modified to match the data points needed for this trial, then converted our randomisation module to a simpler “add a patient” module. Challenges met in this project were:
- patients receiving one treatment arm needed to remain on that treatment for the study even after the participating ICU switched to using the other arm. Recording and reporting on patients that received both treatments in error was incorporated
- patients transferring to other participating ICUs were tracked in Spinnaker and continued to receive the fluid arm they initially received
To hear more about how Spinnaker helped with the SPLIT Trial, get in touch.
More on the SPLIT trial …