Automated Peritoneal Dialysis Versus Intermittent Hemodialysis in Acute Kidney Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-24

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a multi-center randomized clinical trial study. The purpose of this study is to examine safety, feasibility and efficacy of automated peritoneal dialysis as compared with intermittent hemodialysis for AKI patients with indications for dialysis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Study of Efficacy and Safety of Automated PD in Urgent Start Dialysis

NCT03754361

ESRD

TERMINATED NA

Comparison of the Impact of Dialysis Treatment Type on Patient Survival

NCT00510549

End Stage Renal Disease

COMPLETED PHASE4

Intensive Versus Regular Dosage For PD In AKI.

NCT03438877

Peritoneal Dialysis Acute Kidney Injury

TERMINATED NA

Urgent-start Peritoneal Dialysis in ESRD Patients：A Multi-center Study

NCT02946528

End-Stage Renal Disease

COMPLETED NA

A Study of Domestic Automated Peritoneal Dialysis Machine

NCT02388945

Disorders Associated With Peritoneal Dialysis

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The incidence of acute kidney injury (AKI) is rapidly increasing worldwide. This is a common and devastating disorder, especially in critical illnesses, affecting 5-8% of all hospitalized patients and up to 30% of those in intensive care units, with high mortality. About 50-80% critical patients with AKI needed dialysis treatment. Intermittent hemodialysis (IHD) might be the most-commonly modalities applied in AKI patients requiring dialysis. However, no data of randomized study concerning renal recovery and treatment efficiency of AKI patients treated with APD is available in Chinese adult patients. This study is a 2-armed randomized controlled non-blind non-inferior trial to explore the feasibility, efficacy, and safety of APD in AKI patients as compared with intermittent hemodialysis. Base on the sample size estimation, 100 subjects (n=50 in each arm) should be enrolled in this study. The primary outcome is the rate of renal recovery (independence of dialysis) in the first 21days after initiation of renal replacement.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Kidney Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects eligible for this study will be randomized into APD group and IHD group. In APD group, subjects will receive PD catheter placement and subsequent APD treatment. In IHD group, subjects will receive un-tunneled hemodialysis catheter placement and subsequent hemodialysis.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

APD group

Subjects will receive PD catheter placement and subsequent automated peritoneal dialysis treatment.

Group Type EXPERIMENTAL

Automated peritoneal dialysis

Intervention Type OTHER

The prescription of automated peritoneal dialysis:

* The first 48-72 hours dose: 0.8-2.0 liter exchange with 1-2 hour-cycle (8-36 liters per day); After initial 48-72 hours, 1.0-2.5L exchange with 2-6 hour-cycle (at least 8 liters per day), if the acidosis, hyperkalemia and pulmonary edema are corrected.
* The minimal target weekly Kt/V is 2.1-3.5/W.

IHD group

Subjects will receive un-tunneled hemodialysis catheter placement and subsequent intermittent hemodialysis.

Group Type ACTIVE_COMPARATOR

Intermittent hemodialysis

* Age under 18 years, or older than 80 years
* Urinary tract obstruction; acute interstitial nephritis or rapidly progressive glomerulonephritis needed immunoinhibitory therapy
* Previously received renal replacement therapy(RRT) of any type/presence of dialysis access during the current illness.
* Pre-existing severe chronic kidney disease (baseline serum creatinine\>4mg/dl) more than 10 days prior to initiation of first RRT.
* Absolute contraindication of peritoneal dialysis such as recent abdominal surgery (\<1month), multiple abdominal surgeries.
* Absolute contraindication for hemodialysis such as hemodynamic instability (systolic blood pressure \<80mmHg).
* Pregnant.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No