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Thanks to all Participating Centers and collaborators for engaging in this research program!

Thanks to the CCCTG for endorsing this research project.

Pilot Study


Study Design:
A multi-center, prospective, parallel group, randomized study of 120 patients.

Setting:
Approximately 12 ICUs in Canada and the United States.

Study Population:
Male and female critically ill adult patients in shock and receiving vasopressors after the early phase of resuscitation.

Study Intervention:
Patients will be randomly allocated to receive vasopressors titrated to a MAP of 75-80mmHg or 60-65mmHg.

Outcomes:
The primary outcome will be the difference in the means of mean arterial pressures while on vasopressors and we define acceptable adherence (the threshold for feasibility) by a difference of at least 5 mmHg while on vasopressors.  As secondary feasibility outcomes, we will also capture the number of protocol violations.  Tertiary outcomes will explore clinical endpoints such as tissue perfusion, organ dysfunction, complications of vasopressor use, overall resource use in each arm and mortality (28-day, 60-day, 90-day).

Enrollment Target Reached!

Enrollment into the pilot trial was so rapid we finished more than 1 year ahead of schedule. The pilot enabled us to develop and test implement measures to optimize protocol adherence for the current proposal. Having completed the trial early allowed us to continue to enroll during the transition period to the larger study. We extended our sample size by 40 (total 120) and allowing centers that were slower to receive ethics approval to participate and prepare for the larger trial. We have established an efficient infrastructure for both Canadian and international participation in the study. Combining the pilot and transition phases, 12 participating sites from Alberta, Ontario, Québec, Nova Scotia and the United States (St Louis) contributed data that we will incorporate into the larger trial. We have demonstrated that the proposed international trial is feasible!