Conservative Dialysis Approach for Acute Kidney Injury
(LIBERATE-D Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of California, San Francisco
Disqualifiers: Liver disease, Nephrectomy, Heart failure, others
No Placebo Group
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?The goal of the LIBERATE-D clinical trial is to improve outcomes for patients recovering from dialysis-requiring acute kidney injury (AKI-D). The impact of a conservative dialysis strategy compared to standard clinical practice of thrice-weekly dialysis will be examined to help generate knowledge for how to guide delivery of dialysis to facilitate renal recovery.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment for Conservative Dialysis Approach for Acute Kidney Injury?
Research shows that automated peritoneal dialysis (APD) is at least as effective as continuous ambulatory peritoneal dialysis (CAPD) for patients with end-stage kidney disease, with similar survival rates and no major differences in overall mortality. APD has been found to improve certain clinical outcomes like ultrafiltration and urea clearance compared to CAPD.
12345Is conservative dialysis generally safe for humans?
Continuous ambulatory peritoneal dialysis (CAPD) has been used for many years and is considered a safe treatment for kidney failure, with a relatively low mortality rate and manageable complications like peritonitis (infection of the abdominal lining). Automated peritoneal dialysis (APD) has also shown no major safety concerns in studies, with no fluid overload or significant abdominal discomfort reported.
56789How does the Conservative Dialysis Approach for Acute Kidney Injury differ from other treatments?
The Conservative Dialysis Approach for Acute Kidney Injury is unique because it combines peritoneal dialysis (PD) and hemodialysis (HD) to address the limitations of PD alone, especially after the loss of residual renal function. This combination allows for better control of the uremic state and more effective solute removal, providing a more comprehensive treatment compared to using PD or HD alone.
1011121314Eligibility Criteria
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.Inclusion Criteria
I don't need drugs to maintain my blood pressure and I am scheduled for occasional dialysis.
Your kidney function, as measured by eGFR, is at least 15 mL/min/1.73 m2.
I am 18 years old or older.
+1 more
Exclusion Criteria
Pregnant
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.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomized to either a conservative dialysis strategy or conventional thrice-weekly dialysis
Up to 28 days
Thrice-weekly visits for dialysis in the conventional arm
Follow-up
Participants are monitored for renal recovery and other outcomes after treatment
Up to 90 days
Long-term follow-up
Participants are monitored for all-cause mortality and other long-term outcomes
Up to 12 months
Participant Groups
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.
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
Dialysis is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Dialysis for:
- Acute kidney injury
- Chronic kidney disease
- End-stage renal disease
🇺🇸 Approved in United States as Dialysis for:
- Acute kidney injury
- Chronic kidney disease
- End-stage renal disease
🇨🇦 Approved in Canada as Dialysis for:
- Acute kidney injury
- Chronic kidney disease
- End-stage renal disease
🇯🇵 Approved in Japan as Dialysis for:
- Acute kidney injury
- Chronic kidney disease
- End-stage renal disease
🇨🇳 Approved in China as Dialysis for:
- Acute kidney injury
- Chronic kidney disease
- End-stage renal disease
🇨🇭 Approved in Switzerland as Dialysis for:
- Acute kidney injury
- Chronic kidney disease
- End-stage renal disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Washington University in St Louis/Barnes-Jewish HospitalSaint Louis, MO
Intermountain Medical CenterMurray, UT
University of Califonia, San FranciscoSan Francisco, CA
Vanderbilt University Medical CenterNashville, TN
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
Vanderbilt University Medical CenterCollaborator
National Institutes of Health (NIH)Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Chronic peritoneal dialysis: seven-year experience in a large Hispanic program. [2020]To analyze the clinical results of our patient population on continuous ambulatory peritoneal dialysis (CAPD) and continuous cycling peritoneal dialysis (CCPD) in relation to treatment modality systems, compliance, rehabilitation characteristics, complications, and survivals.
Automated peritoneal dialysis in Hong Kong: there are two distinct groups of patients. [2013]To compare the clinical outcome between continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD) in specific subgroups of patients.
Automated Peritoneal Dialysis: Patient Perspectives and Outcomes. [2021]A steadily increasing number of end stage kidney disease (ESKD) patients are maintained on automated peritoneal dialysis (APD) worldwide, in long-standing as well as in more recently established peritoneal dialysis (PD) programs. A better understanding of the technique, paralleled by progress in involved technology, sustained this growth to the point that APD has become the prevalent mode of PD delivery in most high-income countries. While APD is now regarded to be at least as efficient as continuous ambulatory peritoneal dialysis (CAPD) with regard to major biomedical outcomes, its impact on patient-reported outcomes has been less investigated. This paper reviews the main outcomes of APD from a clinical point of view and from the person on dialysis perspective.
Similar survival on automated peritoneal dialysis and continuous ambulatory peritoneal dialysis in a large prospective cohort. [2021]Automated peritoneal dialysis (APD) is increasingly used in comparison with continuous ambulatory peritoneal dialysis (CAPD). Although APD is expected to improve survival, convincing evidence of major advantages is lacking. The objective was to investigate whether overall mortality and technique failure of incident dialysis patients treated with APD are different from those treated with CAPD.
[Clinical experience of automated peritoneal dialysis]. [2016]For uremic patients on continuous ambulatory peritoneal dialysis who are complicated with peritonitis, hernia or burn out of meticulous procedure, automated peritoneal dialysis (APD) is a new alternative therapy. We started our APD program by continuous cyclic peritoneal dialysis (CCPD) method from October, 1991 and this study included 3 CAPD patients. Our studies showed high dose CCPD was better than CAPD in ultrafiltration and urea clearance with similar weekly creatinine clearance and weekly KT/V urea. During the one year treatment course, there was no signs of fluid overload. We performed once to twice day time exchange by low volume dialysate (1500-1600ml) There was no events of abdomen discomfort due to increase intraabdominal pressure or recurrent hernia in susceptible patient. The decrease in day time exchange frequency obviously reduced patients'loading. One patient changed to high dose CCPD due to underdialysis after stand CCPD therapy. Two patients returned to hemodialysis due to severe peritonitis and technique method, but careful assessment of dialysis adequacy with PET test and KT/V evaluation is mandatory.
Improving outcome of CAPD: twenty-five years' experience in a single Korean center. [2020]Continuous ambulatory peritoneal dialysis (CAPD) is an established treatment for end-stage renal disease (ESRD). We investigated the outcome of CAPD over a period of 25 years at our institution.
[Non-infectious complications during treatment with continuous peritoneal dialysis (CAPD)]. [2006]Continuous ambulatory peritoneal dialysis (CAPD) is an established effective method of maintenance in patients with end-stage failure. Because of the increasing number of patients treated by this method it is essential to study complications of long-term CAPD, treatment which are connected with high intraabdominal pressure, peritoneal membrane response to non-physiological solutions and systemic metabolic changes.
[Results of treatment with continuous ambulatory peritoneal dialysis. One year observation]. [2006]Results of one-year dialysis adequacy monitoring in 20 patients treated with continuous ambulatory peritoneal dialysis with Baxter dialysis systems were presented. Relatively low mortality rate (10%), stable, within accepted range, peritonitis rate (1 episode per 16.4 patient-months), and high percentage of patients dialysed adequately (75%), let us to conclude, that CAPD may be a safe renal replacement therapy modality, which may be, in selected cases, an alternative method to hemodialysis.
Continuous ambulatory peritoneal dialysis peritonitis: Microbiology and outcomes. [2023]Continuous ambulatory peritoneal dialysis (CAPD) is now a preferred mode of the treatment in patients with end-stage renal disease, but peritonitis remains to be a shortcoming of CAPD. High-culture negativity, emerging drug resistance and peritoneal dialysis (PD)-related morbidity and mortality have been a challenge to tackle.
Long-term successful nocturnal intermittent peritoneal dialysis: a ten-year case study. [2004]We report a case of polycystic kidney disease, successfully dialyzed using nocturnal intermittent peritoneal dialysis (NIPD) for ten years. Other forms of renal replacement therapy, which included hemodialysis, continuous ambulatory peritoneal dialysis (CAPD), intermittent peritoneal dialysis (IPD), and renal transplantation, were unsuitable for the patient. A peritoneal equilibration test revealed a 4-h D/P creatinine (Cr) ratio of 0.54. In January 1984, the patient began NIPD for 12 h, using a dialysis solution dose of 14 L/day, and 2 L/exchange. In January 1986, because of clinical under-dialysis, the dialysis solution dose was increased to 20 L/day, with an exchange volume of 1.57 L. The prescribed outflow time was 20 min. Dialysis was still inadequate with a weekly corrected Cr clearance (CoCrCl/w) of 33.6 L. In August 1986, the outflow time was reduced to 14 min and the total dialysis time to 11 h. Despite the latter, the efficiency of dialysis was greater because of longer full contact between dialysate and peritoneum. The last change resulted in marked clinical improvement and CoCrCl/w increased to 39.9 L. Over the years, the patient's peritoneal transport changed to high average (4-h D/P Cr = 0.74) and NIPD provided even better clearances (CoCrCl/w = 59.96 L in 1994). The report emphasizes that NIPD, if properly tailored, can provide clinically adequate long-term dialysis.
Peritoneal dialysis as a valuable tool for blood purification. [2017]Peritoneal dialysis (PD) is used to a limited extent in most developed countries for haemodialysis (HD). However, the survival using PD does not differ from that using HD and may even to some extent favour the use of PD. In patients who are expected to stay for many years in a chronic renal replacement therapy programme an important reason for starting with PD is to save the vascular access for later use. Other favourable issues are also discussed. This paper will also cover various aspects of how to reduce the risk of problems in a PD programme. In addition the concept of early start or acute start of peritoneal dialysis will be covered.
Intraperitoneal administration of drugs in peritoneal dialysis patients: a review of compatibility and guidance for clinical use. [2022]Peritoneal dialysis (PD) is an effective home-based therapy for end-stage renal failure. Intraperitoneal administration of drugs to PD patients is particularly important for the treatment of peritonitis. Clinicians need to know that the administered drug is compatible with both the PD solution and its container. A detailed literature search on drug compatibility and stability was performed and results of all published stability studies are presented for all drugs, PD solutions, and containers studied. These data will aid clinicians managing PD patients and provide a resource to demonstrate which drugs have been shown to be stable in various PD solutions and solution containers. This is important information to assist clinicians in applying effective treatments, in particular, for peritonitis.
Complementary dialysis for daily dialysis. [2007]The greatest benefit of PD ist the continuous maintenance of a stable electrolyte and acid-base balance, as well as a continuous solute, sodium and water removal. Moreover, PD is effective in preserving residual renal function (RRF). However, when RRF declines, complications will occur if not compensated for by an increase in both the dialysis dose and ultrafiltration. Combination therapy PD and HD has been implemented to address the weakness of PD. The weak points of PD are declining UF volume and solute removal over time. The most important weak point of HD is the intermittent nature of the treatment. Based on this, the following concept was developed. At the start of dialysis, PD should be initiated in order to maintain RRF. In this stage, the function of PD is a complement to the RRF. When RRF declines, combination PD and HD should be considered. Subsequently, to achieve sufficient solute removal and ultrafiltration, the number of HD sessions should increase and PD prescription may decrease, resulting in three HD sessions per week and low-volume PD on non-HD days. Thus, PD complements HD in the end. If this integration can become a reality, we can accomplish 'real' daily dialysis.
Evaluation of dialysis dose during combination therapy with peritoneal dialysis and hemodialysis. [2013]Peritoneal dialysis (PD) is effective way to preserve residual renal function (RRF) and should be the first-line dialysis option. However, after the loss of RRF, there are limitations to how well PD alone can control the uremic state. Combination therapy with PD and hemodialysis (PD+HD) is the simplest way to deal with these limitations. The general prescription for PD+HD should be 5-6 days of PD and 1 HD session weekly. To determine the adequacy of PD+HD, we adopted the equivalent renal clearance (EKR), first transforming the weekly PD adequacy index (Kt/V), and then evaluating total clearance from both modalities. However the EKR may overestimate the dialysis dose. To accurately track dialysis dose, we use the total effluent (PD, RRF and HD) sampling method to yield Kt/Vef and creatinine clearance (CCref). In comparing PD+HD with 7 days of PD alone, we found that weekly Kt/Vef increased to 2.27 +/- 0.43 from 1.55 +/- 0.4, and weekly CCref increased to 60.3 +/- 9.2 L/1.73 m2 from 42.0 +/- 7.7 L/1.73 m2 (p