Sepsis resuscitation and acute kidney injury: a prospective nested cohort study of acute kidney injury in the ARISE FLUIDS Randomised Controlled Trial.

The George Institute for Global Health0 sites100 target enrollmentJuly 13, 2022

Overview

No summary available.

Registry

who.int

Start Date

July 13, 2022

End Date

TBD

Last Updated

3 years ago

Study Type

Observational

Sex

All

Sponsor

•Eligible for the ARISE FLUIDS RCT. This study's inclusion criteria are as follows:
•1\.Clinically suspected infection
•2\.Systolic blood pressure (SBP) \<90 mm Hg or mean arterial pressure (MAP) \<65 mm Hg, despite a 1000 mLs cumulative total bolus of IV fluid administered over a maximum of 60 minutes; including pre\-hospital boluses
•3\.Arterial or venous blood lactate \>2\.0 mmol/L
•4\.At least one dose of an intravenous antimicrobial has been commenced

•Ineligible for the ARISE FLUIDS RCT. This study's exclusion criteria are as follows:
•1\.Age \< 18 years
•2\.Confirmed or suspected pregnancy
•3\.Transferred from another acute care facility
•4\.\>2L total IV fluid administered (including prehospital fluids but excluding drugs and flushes)
•5\.Hypotension suspected to be due to a non\-sepsis cause
•6\.More than 6 hours has elapsed since presentation to the ED or more than 2 hours has elapsed since last Inclusion criterion has been met
•7\.Treating clinician considers that one or both of the treatment regimens are not suitable for the patient or the study protocol cannot be delivered e.g. limitation of care, requirement for immediate surgery
•8\.Death is considered imminent or inevitable
•9\.Underlying disease that makes survival to 90 days is unlikely