Clinical trial NCT03598387: Automated Peritoneal Dialysis Versus Intermittent Hemodialysis in Acute Kidney Injury
Official title: The Study of Safety, Feasibility and Efficacy of Automated Peritoneal Dialysis in Acute Kidney Injury as Compared With Intermittent Hemodialysis, a Multi-center Non-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Kidney Injury
Keywords: acute kidney injury
automated peritoneal dialysis
intermittent hemodialysis
renal recovery
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: First Hospital of China Medical University
name: First Affiliated Hospital Xi'an Jiaotong University
name: Beijing Anzhen Hospital
name: Xiangya Hospital of Central South University
name: Baxter Healthcare Corporation
First posted: 2018-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* AKI patients according to Acute Kidney Injury Network criteria
* Rapidly rising serum creatinine level (a sudden increase of at least 30%)
* Meeting the indications for dialysis

  * Uremia or azotemia (BUN\>80 mg/dl)
  * Fluid overload (after diuretics use)
  * Electrolyte imbalance (K\>5.5 mEq/L after clinical treatment)
  * Acid-base disturbance (pH\<7.2 and bicarbonate\<10mEq/L after clinical treatment)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The rate of renal function recovery (independence of dialysis)
timeFrame: At 21 days after the initiation of dialysis
Secondary outcomes:
measure: All-cause mortality within 21 days
timeFrame: At 21 days after the initiation of dialysis
measure: All-cause mortality within 90 days
timeFrame: At 90 days after the initiation of dialysis
measure: Access related complications within 21 days
timeFrame: At 21 days after the initiation of dialysis
measure: Access related complications within 90 days
timeFrame: At 90 days after the initiation of dialysis
measure: Dialysis related complications within 21 days
timeFrame: At 21 days after the initiation of dialysis
measure: The percentage of participants requiring termination of primary dialysis modality
timeFrame: At 90 days after the initiation of dialysis
measure: Length of stay in hospital
timeFrame: From the time of admission to the time of discharge, up to 90 days
measure: Herth Hope Index within 21 days
timeFrame: At 21 days after the initiation of dialysis
measure: Health Status Questionnaire (Short Form-36) score within 21 days
timeFrame: At 21 days after the initiation of dialysis
measure: Mini-Mental State Examination (MMSE) score within 21 days
timeFrame: At 21 days after the initiation of dialysis
measure: Simplified Nutritional Appetite Questionnaire (SNAQ) score within 21 days
timeFrame: At 21 days after the initiation of dialysis
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shannxi
Study officials:
affiliation: Division of Nephrology, Peking Union Medical College Hospital
name: Limeng Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gabriel DP, Nascimento GV, Caramori JT, Martim LC, Barretti P, Balbi AL. Peritoneal dialysis in acute renal failure. Ren Fail. 2006;28(6):451-6. doi: 10.1080/08860220600781245.
citation: Gabriel DP, Caramori JT, Martim LC, Barretti P, Balbi AL. High volume peritoneal dialysis vs daily hemodialysis: a randomized, controlled trial in patients with acute kidney injury. Kidney Int Suppl. 2008 Apr;(108):S87-93. doi: 10.1038/sj.ki.5002608.