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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
Intermittent hemodialysis will be performed 3-4h of each session and 2-5 times per week. The prescription will be adjusted based on patients' conditions to ensure spKT/V≥1.3.
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGXiangya Hospital, Central South University
Changsha, Hunan, China
The rate of renal function recovery (independence of dialysis)
Patients do not require dialysis, urine output\>1000ml/d and progressive drop in serum creatinine(\<4mg/dl) and BUN(\<50mg/dl).
Time frame: At 21 days after the initiation of dialysis
All-cause mortality within 21 days
The rate of all-cause of deaths at 21 days after the initiation of dialysis
Time frame: At 21 days after the initiation of dialysis
All-cause mortality within 90 days
The rate of all-cause of deaths at 90 days after the initiation of dialysis
Time frame: At 90 days after the initiation of dialysis
Access related complications within 21 days
* Infections: peritonitis (APD), catheter-related infections (IHD) * Mechanical complications: catheter leakage and migration (APD), catheter obstruction (IHD) * Exit site bleeding, pneumothorax, hernia
Time frame: At 21 days after the initiation of dialysis
Access related complications within 90 days
* Infections: peritonitis (APD), catheter-related infections (IHD) * Mechanical complications: catheter leakage and migration (APD), catheter obstruction (IHD) * Exit site bleeding, pneumothorax, hernia
Time frame: At 90 days after the initiation of dialysis
Dialysis related complications within 21 days
Hypotension, hypoglycemia, bleeding, reactions to dialyzers, etc
Time frame: At 21 days after the initiation of dialysis
The percentage of participants requiring termination of primary dialysis modality
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The First Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGThe First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shannxi, China
RECRUITINGCondtions leading to termination of primary dialysis modality, including bleeding, thromboebolism events, infections, access related complications and inadequate dialysis
Time frame: At 90 days after the initiation of dialysis
Length of stay in hospital
The time length of stay as an inpatient
Time frame: From the time of admission to the time of discharge, up to 90 days
Herth Hope Index within 21 days
Measure hope of patients using Herth Hope Index. Total possible points on the total scale is 48 points. The higher the score the higher the level of hope. To each question, strongly agree=4, agree=3, disagree=2, strongly disagree=1. Note: the scoring items need to be reversed scored in question 3 and 6.
Time frame: At 21 days after the initiation of dialysis
Health Status Questionnaire (Short Form-36) score within 21 days
Health Status Questionnaire (Short Form-36) is one of the most widely used generic measures of health-related quality of life and has been shown to discriminate between subjects with different chronic conditions and between subjects with different severity levels of the same disease.It generates 8 subscales and two summary scores. The 8 subscales are: physical functioning (Range 0-100), role limitations due to physical problems (Range 0-100), bodily pain (Range 0-100), general health perceptions (Range 0-100), vitality (Range 0-90), social functioning (Range 12.5-100), role-limitations due to emotional problems (Range 0-100), and mental health (Range 0-100). The two summary scores are the physical component summary (Range 13.6-61.9) and the mental component summary (Range 15.6-70.0). The higher the score is, the better quality of life of the patient is.
Time frame: At 21 days after the initiation of dialysis
Mini-Mental State Examination (MMSE) score within 21 days
The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used to measure cognitive impairment. The maximum score is 30. The following three cut-off levels should be employed to classify the severity of cognitive impairment: no cognitive impairment=24-30; mild cognitive impairment=18-23; severe cognitive impairment=0-17.
Time frame: At 21 days after the initiation of dialysis
Simplified Nutritional Appetite Questionnaire (SNAQ) score within 21 days
Simplified Nutritional Appetite Questionnaire (SNAQ) ask the subject to complete answer 4 questions about the appetite. Tally the results based upon the following numerical scale: a=1, b=2, c=3, d=4, e=5. The sum of the scores for the individual items constitutes the SNAQ score. The maximum SNAQ score is 20. SNAQ score \< 14 indicates significant risk of at least 5% weight loss within six months.
Time frame: At 21 days after the initiation of dialysis