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Conservative Dialysis Approach for Acute Kidney Injury (LIBERATE-D Trial)
N/A
Recruiting
Led By Kathleen Liu, MD, PhD, MAS
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hemodynamic stability: not requiring vasopressor support and with planned intermittent dialysis
≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to date of death from any cause, assessed up to 12 months
Awards & highlights
LIBERATE-D Trial Summary
This trial is testing whether a more conservative approach to dialysis improves outcomes for patients with acute kidney injury who require dialysis.
Who is the study for?
This trial is for adults over 18 with acute kidney injury needing dialysis, who are stable without vasopressor support and have a history of good kidney function. It's not for pregnant individuals, prisoners, those unable to consent or lacking a decision-maker, patients with certain other health conditions or treatments, or if they've been on dialysis for more than 3 months.Check my eligibility
What is being tested?
The LIBERATE-D study is testing whether less frequent dialysis (a conservative strategy) can be as effective as the standard three times weekly sessions in helping patients recover from acute kidney injury that required initial dialysis treatment.See study design
What are the potential side effects?
Potential side effects may include complications related to reduced frequency of dialysis such as fluid overload, increased levels of waste products in the blood like urea and creatinine, electrolyte imbalances, and potential delays in recovery of kidney function.
LIBERATE-D Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I don't need drugs to maintain my blood pressure and I am scheduled for occasional dialysis.
Select...
I am 18 years old or older.
Select...
I am hospitalized with acute kidney injury requiring dialysis, as diagnosed by my kidney doctor.
LIBERATE-D Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to date of death from any cause, assessed up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to date of death from any cause, assessed up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients with renal recovery at hospital discharge
Secondary outcome measures
Dialysis-free days to study day 28
Number of dialysis sessions/week
Other outcome measures
All-cause day 28 mortality
All-cause day 90 mortality
All-cause in-hospital mortality
+5 moreSide effects data
From 2013 Phase 4 trial • 86 Patients • NCT0115636333%
Hypertension
28%
Cough
27%
Upper respiratory tract infection
19%
Constipation
16%
Abdominal pain upper
16%
Headache
16%
Pruritus
15%
Hyperphosphataemia
15%
Hyperkalaemia
14%
Procedural hypotension
14%
Oedema peripheral
14%
Insomnia
13%
Diarrhoea
13%
Muscle spasms
13%
Rhinorrhoea
12%
Dizziness
10%
Oropharyngeal pain
10%
Nasopharyngitis
10%
Productive cough
9%
Hyperparathyroidism
8%
Haemodialysis complication
8%
Urinary tract infection
7%
Regurgitation
7%
Hypotension
6%
Contusion
6%
Procedural hypertension
6%
Wound
6%
Pyrexia
6%
Abdominal distension
6%
Dermatitis
1%
Acute pulmonary oedema
1%
Pulmonary haemorrhage
1%
Chronic hepatitis
1%
Acute respiratory failure
1%
Acute myocardial infarction
1%
Arteriovenous fistula operation
1%
Alcoholic liver disease
1%
Abdominal infection
1%
Fracture
1%
Hepatic encephalopathy
1%
Haemoptysis
1%
Pleural effusion
1%
Bladder cancer recurrent
1%
Gastric ulcer
1%
Septic embolus
1%
Muscular weakness
1%
Respiratory tract infection
1%
Labile blood pressure
1%
Cardiac failure congestive
1%
Pharyngitis
1%
Septic shock
1%
Diabetes mellitus inadequate control
1%
Bronchopneumonia
1%
Urinary incontinence
1%
Bacteraemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mircera
LIBERATE-D Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ConservativeExperimental Treatment1 Intervention
Conservative dialysis strategy--dialysis prescribed only when specific metabolic or clinical indications are met. These indications are: blood urea nitrogen >112 mg/dL (40 mmol/L; blood potassium concentration >6 mmol/L; blood potassium concentration >5.5 mmol/L despite medical treatment; arterial blood gas pH <7.15, or in the absence of an available blood gas, serum bicarbonate <12 mmol/L, acute pulmonary edema due to fluid overload, responsible for hypoxemia requiring oxygen flow rate >5 L/min or equivalent via face mask/tracheostomy mask to maintain SpO2 >95% or requiring FiO2 >50% in patients with tracheostomy already on invasive or non-invasive mechanical ventilation and despite diuretic therapy; clinician judgement
Group II: ConventionalActive Control1 Intervention
Thrice-weekly intermittent dialysis until pre-specified criteria for recovery are met
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dialysis
2008
Completed Phase 4
~160
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,335 Total Patients Enrolled
7 Trials studying Acute Kidney Injury
3,303 Patients Enrolled for Acute Kidney Injury
Vanderbilt University Medical CenterOTHER
857 Previous Clinical Trials
671,973 Total Patients Enrolled
3 Trials studying Acute Kidney Injury
12,781 Patients Enrolled for Acute Kidney Injury
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,656 Total Patients Enrolled
5 Trials studying Acute Kidney Injury
241 Patients Enrolled for Acute Kidney Injury
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need a device or continuous medication to support my heart's pumping.I need dialysis for reasons other than kidney failure, like liver disease.I don't need drugs to maintain my blood pressure and I am scheduled for occasional dialysis.My kidney was removed and it caused acute kidney injury.I need a lot of oxygen support to keep my oxygen levels above 95%.I received a kidney transplant during my current hospital stay.I cannot give consent and have no one to make decisions for me.Your kidney function, as measured by eGFR, is at least 15 mL/min/1.73 m2.I have been on dialysis for more than 3 months.I am on a breathing machine through a tube in my windpipe.I am 18 years old or older.I am hospitalized with acute kidney injury requiring dialysis, as diagnosed by my kidney doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Conservative
- Group 2: Conventional
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.
Is this experiment currently seeking participants?
"Affirmative. Data presented on clinicaltrials.gov affirms that this investigation, which was initially posted in January of 2020, is recruiting individuals for participation. The study necessitates the recruitment of 220 patients from two distinct locations."
Answered by AI
How many participants is this experiment recruiting?
"Affirmative, clinicaltrials.gov has information that this medical research is in the process of enrolling patients. Originally posted on January 23rd 2020 and revised as recently as October 31st 2022, 220 participants are sought from 2 locations."
Answered by AI
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