Post-Approval Safety Study of Updated ACCUSOL 35: ACCUPASS
Research type
Research Study
Full title
A Multicenter, Non-interventional, Observational, Post-Approval Safety Study of Updated ACCUSOL 35 Solutions in Continuous Renal Replacement Therapy (ACCUPASS)
IRAS ID
163233
Contact name
Kiran Salaunkey
Contact email
Sponsor organisation
Baxter Healthcare Corporation
Clinicaltrials.gov Identifier
ENCEPP/SDPP/6800, EU PAS register number
Duration of Study in the UK
1 years, 8 months, 20 days
Research summary
Updated ACCUSOL 35 formulations were developed to prevent calcium carbonate precipitate formation during continuous renal replacement therapy (CRRT) administration. The objective of this study is to confirm the prevention of calcium carbonate precipitate formation during CRRT by the use of the updated ACCUSOL 35 solutions under normal clinical use conditions.
This is a multicenter, non-interventional, single-arm, observational, post-approval safety study in adult patients undergoing CRRT using any ACCUSOL 35 solution(s). CRRT therapy will be administered in accordance with the intensive care unit’s usual clinical practice. The CRRT lines will be inspected every 30 minutes for the duration of the therapy, as described in the labelling for ACCUSOL 35 solutions.
Study staff will record the study data during administration of CRRT with ACCUSOL 35 solution. The planned maximum study observation period is 32 hours: from 40 hours after CRRT with the current circuit was started until 72 hours of treatment has been administered using that same circuit.
The study will include approximately 240 adult patients enrolled at approximately 20 to 25 hospitals, with medical or surgical ICUs that regularly treat CRRT patients using ACCUSOL 35 solutions.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
14/EE/1276
Date of REC Opinion
3 Feb 2015
REC opinion
Further Information Favourable Opinion