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Fluid Removal Strategies for Acute Kidney Injury (RELIEVE-AKI Trial)
N/A
Recruiting
Led By Raghavan Murugan, MD, MS, FRCP
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stage 3 acute kidney injury according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Attending intensivist or nephrologist intending to remove net fluid using CKRT for at least 48 hours
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 21 months
Awards & highlights
RELIEVE-AKI Trial Summary
This trial will compare the effects of different rates of fluid removal in critically ill patients with acute kidney injury and fluid overload.
Who is the study for?
Adults over 18 with severe acute kidney injury needing fluid removal via dialysis can join. They must be planned for at least 48 hours of continuous kidney replacement therapy (CKRT) for volume management. Excluded are pregnant individuals, those on certain life support devices, patients not expected to survive a day, or already receiving chronic hemodialysis.Check my eligibility
What is being tested?
The trial is testing two strategies for removing excess fluid in critically ill patients with acute kidney injury: one uses a restrictive approach and the other a liberal approach to determine which is safer and more effective.See study design
What are the potential side effects?
Potential side effects may include additional stress on vital organs due to varying rates of fluid removal during dialysis, which could lead to complications or worsen the patient's condition.
RELIEVE-AKI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney injury is severe, as per KDIGO stage 3.
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My doctor plans to use a special kidney treatment on me for at least 2 days.
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I am starting or planning to start CKRT for fluid management.
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I am 18 years old or older.
RELIEVE-AKI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 21 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 21 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Delivered UFnet rates.
No. of participants with protocol deviation.
Participant recruitment rate over 21 months
Secondary outcome measures
Cumulative fluid balance
Daily fluid balance
Dependence on kidney replacement therapy
+6 moreOther outcome measures
No. of episodes of intradialytic cardiac arrhythmias
No. of episodes of stopping of CKRT system due to hemofilter clotting or clogging.
No. of intradialytic hypertension episodes
+18 moreRELIEVE-AKI Trial Design
2Treatment groups
Active Control
Group I: Liberal UFnet StrategyActive Control1 Intervention
Fluid removal will be titrated to keep net ultrafiltration rate between 2.0-5.0 mL/kg/h
Group II: Restrictive UFnet StrategyActive Control1 Intervention
Fluid removal will be titrated to keep net ultrafiltration rate between 0.5-1.5 mL/kg/h
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,722 Previous Clinical Trials
16,342,824 Total Patients Enrolled
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86,335 Patients Enrolled for Acute Kidney Injury
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
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Mayo ClinicOTHER
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5,741 Patients Enrolled for Acute Kidney Injury
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on long-term outpatient hemodialysis.I am receiving care focused on my comfort rather than curing my illness.My kidney injury is severe, as per KDIGO stage 3.You are very sick and not expected to live for more than 24 hours.You are pregnant.I am experiencing breathing difficulties due to fluid in my lungs and I am not on a breathing machine.I have been on fluid removal treatment for more than 48 hours.My doctor plans to use a special kidney treatment on me for at least 2 days.You are currently being treated with certain medical devices to help your heart or lungs.I am a brain dead organ donor.I am starting or planning to start CKRT for fluid management.I have had, or am currently in for, a kidney transplant.I have not received a large volume of fluids (more than 200 mL/h for over 6 hours).I am 18 years old or older.You do not plan to have excess fluid removed by a doctor who specializes in critical care or kidney health.I needed dialysis due to a drug overdose.I am not in a clinical trial that affects my body's fluid balance significantly.
Research Study Groups:
This trial has the following groups:- Group 1: Liberal UFnet Strategy
- Group 2: Restrictive UFnet Strategy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for individuals wanting to join the research program?
"Indeed, the research project is still accepting individuals. This endeavor was originally posted on July 5th 2022 and has had a recent alteration as of October 10th 2022."
Answered by AI
What is the principal objective of this research endeavor?
"This trial aims to assess participant recruitment over a period of 21 months. The primary outcome will be evaluated until the patient discontinues continuous kidney replacement therapy, or on day 28. Secondary outcomes include duration of mechanical ventilation, organ failure free days and cumulative fluid balance while receiving renal treatment in hospital."
Answered by AI
What is the current recruitment size for this trial?
"Affirmative. The public records on clinicaltrials.gov illustrate that this research programme is currently looking for test subjects, with the trial first posted on July 5th 2022 and last updated on October 10th 2022. A total of 144 individuals from 2 different sites need to be recruited."
Answered by AI
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