Transcription of DETAILED STATISTICAL ANALYSIS PLAN (SAP)
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STATISTICAL ANALYSIS plan Simple Intensive Care Studies-I 1 DETAILED STATISTICAL ANALYSIS PLAN (SAP) 1. Administrative information Title, registration, versions and revisions Full study title A prospective observational study on the value of conventional hemodynamic parameters in estimating cardiac output and predicting mortality in critically ill patients Acronym Simple Intensive Care Studies-I (SICS-I) Local project number 201500144 number NCT02912624 Study protocol version (23 September 2016) SAP version (3 April 2018) SAP revision history None SAP revision justification - SAP revision timing Revision will be conducted after publishing the two main manuscripts.
This statistical analysis plan was added to the study protocol at clinicaltrials.gov, before closure of the database and before any analyses had been conducted. Independent study monitoring was conducted in adherence to the Good Clinical Practice guidelines (10).
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