An interventional study of Automated peritoneal dialysis and Intermittent hemodialysis in Acute Kidney Injury, sponsored by Limeng Chen. Status unknown at 5 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-08.
Sponsored by Limeng Chen · Not applicable, Interventional, and Treatment
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.
1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 786 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Limeng Chen is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Meeting the indications for dialysis
Exclusion Criteria:
Subjects will receive PD catheter placement and subsequent automated peritoneal dialysis treatment.
Other: Automated peritoneal dialysis
Subjects will receive un-tunneled hemodialysis catheter placement and subsequent intermittent hemodialysis.
Other: Intermittent hemodialysis
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.
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
Condtions 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
Plan to share: No — To comply with laws in China, local regulations and hospital policy, IPD sharing might be restricted
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Limeng Chen