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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03598387
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : February 8, 2022
Sponsor:
Collaborators:
First Hospital of China Medical University
First Affiliated Hospital Xi'an Jiaotong University
Beijing Anzhen Hospital
Xiangya Hospital of Central South University
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Limeng Chen, Peking Union Medical College Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Other: Automated peritoneal dialysis Other: Intermittent hemodialysis Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 24, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arms and Interventions
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Arm Intervention/treatment
Experimental: APD group
Subjects will receive PD catheter placement and subsequent automated peritoneal dialysis treatment.
 Other: Automated peritoneal dialysis

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.
Active Comparator: IHD group
Subjects will receive un-tunneled hemodialysis catheter placement and subsequent intermittent hemodialysis.
 Other: Intermittent hemodialysis
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.


Outcome Measures
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Primary Outcome Measures :
  1. The rate of renal function recovery (independence of dialysis) [ Time Frame: At 21 days after the initiation of dialysis ]
    Patients do not require dialysis, urine output>1000ml/d and progressive drop in serum creatinine(<4mg/dl) and BUN(<50mg/dl).


Secondary Outcome Measures :
  1. All-cause mortality within 21 days [ Time Frame: At 21 days after the initiation of dialysis ]
    The rate of all-cause of deaths at 21 days after the initiation of dialysis

  2. All-cause mortality within 90 days [ Time Frame: At 90 days after the initiation of dialysis ]
    The rate of all-cause of deaths at 90 days after the initiation of dialysis

  3. Access related complications within 21 days [ Time Frame: At 21 days after the initiation of dialysis ]
    • Infections: peritonitis (APD), catheter-related infections (IHD)
    • Mechanical complications: catheter leakage and migration (APD), catheter obstruction (IHD)
    • Exit site bleeding, pneumothorax, hernia

  4. Access related complications within 90 days [ Time Frame: At 90 days after the initiation of dialysis ]
    • Infections: peritonitis (APD), catheter-related infections (IHD)
    • Mechanical complications: catheter leakage and migration (APD), catheter obstruction (IHD)
    • Exit site bleeding, pneumothorax, hernia

  5. Dialysis related complications within 21 days [ Time Frame: At 21 days after the initiation of dialysis ]
    Hypotension, hypoglycemia, bleeding, reactions to dialyzers, etc

  6. The percentage of participants requiring termination of primary dialysis modality [ Time Frame: At 90 days after the initiation of dialysis ]
    Condtions leading to termination of primary dialysis modality, including bleeding, thromboebolism events, infections, access related complications and inadequate dialysis

  7. Length of stay in hospital [ Time Frame: From the time of admission to the time of discharge, up to 90 days ]
    The time length of stay as an inpatient

  8. Herth Hope Index within 21 days [ Time Frame: At 21 days after the initiation of dialysis ]
    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.

  9. Health Status Questionnaire (Short Form-36) score within 21 days [ Time Frame: At 21 days after the initiation of dialysis ]
    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.

  10. Mini-Mental State Examination (MMSE) score within 21 days [ Time Frame: At 21 days after the initiation of dialysis ]
    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.

  11. Simplified Nutritional Appetite Questionnaire (SNAQ) score within 21 days [ Time Frame: At 21 days after the initiation of dialysis ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598387


Contacts
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Contact: Peng Xia, MD +86-13811684903 7-xp@163.com
Contact: Ying Wang, MD, PhD +86-18600930725 pumchwy@163.com

Locations
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China, Beijing
Beijing Anzhen Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100029
Contact: Guoqin Wang, MD, PhD    +86-13911282575    wangguoqin1@163.com   
Contact: Yumeng Zhang, BN    +86-13911992835    791751665@qq.com   
Principal Investigator: Hong Cheng, MD, PhD         
Sub-Investigator: Guoqin Wang, MD, PhD         
Sub-Investigator: Zhirui Zhao, MD         
Sub-Investigator: Yu Wang, BN         
Sub-Investigator: Yumeng Zhang, BN         
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Peng Xia, MD    +86-13811684903    7-xp@163.com   
Contact: Ying Wang, MD, PhD    +86-18600930725    pumchwy@163.com   
Principal Investigator: Limeng Chen, MD, PhD         
Principal Investigator: Xuemei Li, MD, PhD         
Sub-Investigator: Peng Xia, MD         
Sub-Investigator: Ying Wang, MD, PhD         
Sub-Investigator: Haiyun Wang, MD, PhD         
Sub-Investigator: Bingyan Liu, MD, PhD         
Sub-Investigator: Zijuan Zhou, BN         
China, Hunan
Xiangya Hospital, Central South University Recruiting
Changsha, Hunan, China, 410008
Contact: Wei Wang, MD, PhD    +86-13755030597    viviwang66@163.com   
Contact: Xiang Ao, MD, PhD    +86-13975806025    2403980692@qq.com   
Principal Investigator: Xiang Ao, MD, PhD         
Sub-Investigator: Xiangcheng Xiao, MD, PhD         
Sub-Investigator: Wei Wang, MD, PhD         
Sub-Investigator: Wannian Nie, MD, MM         
Sub-Investigator: Jing Li, MD, MM         
Sub-Investigator: Zhu Wang, MD         
Sub-Investigator: Fangfang Ye, MD         
Sub-Investigator: Min Zhang, MD         
China, Liaoning
The First Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110001
Contact: Li Yao, MD, PhD    +86-13904035673    liyao_cmu@163.com   
Contact: Xinwang Zhu, MD, PhD    +86-13804056472    zhuxinwang_cmu@126.com   
Principal Investigator: Li Yao, MD, PhD         
Sub-Investigator: Xinwang Zhu, MD, PhD         
Sub-Investigator: Da Sun, MD, MM         
Sub-Investigator: Wei Wu, BN         
Sub-Investigator: Xiaoming Zhao, BN         
Sub-Investigator: Yanan Sun, BN         
China, Shannxi
The First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shannxi, China, 710000
Contact: Jing Lv, MD, PhD    +86-13096938232    drlvjing@163.com   
Contact: Xiaopei Wang, MD, MM    +86-18729306972    1036654642@qq.com   
Principal Investigator: Jing Lv, MD, PhD         
Sub-Investigator: Yingzhou Geng, MD, MM         
Sub-Investigator: Xiaopei Wang, MD, MM         
Sponsors and Collaborators
Limeng Chen
First Hospital of China Medical University
First Affiliated Hospital Xi'an Jiaotong University
Beijing Anzhen Hospital
Xiangya Hospital of Central South University
Baxter Healthcare Corporation
Investigators
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Principal Investigator: Limeng Chen, MD, PhD Division of Nephrology, Peking Union Medical College Hospital
More Information
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Publications:

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Responsible Party: Limeng Chen, Professor of Medicine, Associate Chief of Nephrology Division, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03598387    
Other Study ID Numbers: APD-AKI
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: To comply with laws in China, local regulations and hospital policy, IPD sharing might be restricted

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Limeng Chen, Peking Union Medical College Hospital:
acute kidney injury
automated peritoneal dialysis
intermittent hemodialysis
renal recovery
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases