Automated Peritoneal Dialysis Versus Intermittent Hemodialysis in Acute Kidney Injury (SAFE-APD)

Limeng Chen

Status: Unknown

Conditions: Acute Kidney Injury

Treatments: Other: Intermittent hemodialysis; Other: Automated peritoneal dialysis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03598387

APD-AKI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

APD group

Experimental group

Description:

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

Treatment:

Other: Automated peritoneal dialysis

IHD group

Active Comparator group

Description:

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

Treatment:

Other: Intermittent hemodialysis