None listed
Conditions
Brief summary
Synthetic colloid fluids are frequently used for blood volume expansion in critically ill patients. Starch-based synthetic colloid fluids have been associated with increased risk of acute kidney injury. There is some evidence that gelatine-based colloid fluids may also pose a similar risk. This randomised open-label controlled pilot trial will assess the effects of 4% succinylated gelatine fluid on urinary biomarkers of acute kidney injury in Intensive Care Unit (ICU) patients. This study will also assess clinical outcomes, as secondary endpoints, including change in AKI stage, need for renal replacement therapy (RRT), ICU length of stay and mortality.
Interventions
Intravenous 4% succinylated gelatine fluid at a dose of at least 500mL, to be delivered over less than 60 minutes, Exact dose will be determined by treating physician. The study fluid will also be used for any further fluid boluses required within the next 24-hour period, up to a maximum of 50mL/kg or 3000mL. Any fluid required for blood volume expansion beyond 24 hours is open-label; however, the use of gelatine will be not allowed for 7 days post-enrolment. Other crystalloid fluids or blood pr
Intravenous 4% succinylated gelatine fluid at a dose of at least 500mL, to be delivered over less than 60 minutes, Exact dose will be determined by treating physician. The study fluid will also be used for any further fluid boluses required within the next 24-hour period, up to a maximum of 50mL/kg or 3000mL. Any fluid required for blood volume expansion beyond 24 hours is open-label; however, the use of gelatine will be not allowed for 7 days post-enrolment. Other crystalloid fluids or blood products may be used for purposes other than blood volume expansion, such as maintenance requirements or transfusion. Use of albumin solution is also permitted, if specifically indicated. Volume and type of all fluids delivered with 7 days of enrolment, or until ICU discharge, will be recorded.
Sponsors
Royal Perth Hospital Medical Research Foundation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient within 96 hours of ICU admission 2. Treating physician has made a clinical decision to administer a fluid bolus at a dose of at least 500mL delivered over <60 minutes 3. Presence of a urinary collection system 4. Treating physician believes there is an equipoise in using either GELO or CSL for intravascular volume expansion.
Exclusion criteria
1. When an intravenous fluid bolus is not intended or planned on a clinical ground 2. Age <18 years old 3. Imminent death and/or limitation of care order 4. Severe chronic renal failure (creatinine >265µmol/L prior to acute illness, or end-stage renal failure receiving chronic dialysis) 5. Urine output <10mL/hr over the previous 4 hours 6. Currently receiving RRT, or planned RRT within the next 24 hours 7. Known allergy to GELO 8. Has received GELO in the previous 48 hours 9. Patient has been admitted to ICU for longer than 96 hours 10. Previous enrolment in the study 11. Treating clinician perceives that participation in the study is not in the patient’s best interests
Outcome results
None listed