Acute Kidney Injury in patients randomised to the ARISE FLUIDS Randomised Controlled Trial

Not Applicable

• Conditions: Acute Kidney Injury; Sepsis; Renal and Urogenital - Kidney disease; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12622000988752
• Lead Sponsor: The George Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-13
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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
10.Inability to follow patient up to day-90 e.g. unstable accommodation, overseas visitor
11.Previously enrolled in ARISE FLUIDS

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be the most severe KDIGO AKI Stage recorded within 72 hours of enrolment by treatment group. This will be calculated by analysis of urine output and renal function tests (serum creatinine) collected and recorded as part of standard care in the existing healthcare record. [72 hours from enrolment into ARISE FLUIDS trial]