27 Jul CLEVER-AP Database Lock Statement

Database Lock Statement

The CLEVER-AP clinical trial database evaluating the impact of normal saline or balanced crystalloid on plasma chloride concentration and acute kidney injury in patients with predicted severe acute pancreatitis has been locked after collecting and verifying patient data from 11 clinical sites participating in the study.

With the database now locked, we are arranging for the independent statisticians to have access to the raw data from the Trial. Neither the participating clinical sites other than the investigators will have access to any raw data at this stage.

The statisticians will proceed as quickly as possible with analyses of the raw data and prepare summaries of the Trial results for review by the Principal Investigator, the Steering Committee of the Trial, who will analyze the data with the statisticians in preparation for public announcement and scientific publication.

The Trial Management Committee Of CLEVER-AP

Augusr, 27, 2022