- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03598387
Automated Peritoneal Dialysis Versus Intermittent Hemodialysis in Acute Kidney Injury (SAFE-APD)
February 5, 2022 updated by: Limeng Chen
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ying Wang, MD, PhD
- Phone Number: +86-18600930725
- Email: pumchwy@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Recruiting
- Peking Union Medical College Hospital
-
Principal Investigator:
- Xuemei Li, MD, PhD
-
Sub-Investigator:
- Ying Wang, MD, PhD
-
Sub-Investigator:
- Haiyun Wang, MD, PhD
-
Sub-Investigator:
- Bingyan Liu, MD, PhD
-
Sub-Investigator:
- Zijuan Zhou, BN
-
Contact:
- Ying Wang, MD, PhD
- Phone Number: +86-18600930725
- Email: pumchwy@163.com
-
Beijing, Beijing, China, 100029
- Recruiting
- Beijing Anzhen Hospital, Capital Medical University
-
Contact:
- Guoqin Wang, MD, PhD
- Phone Number: +86-13911282575
- Email: wangguoqin1@163.com
-
Contact:
- Yumeng Zhang, BN
- Phone Number: +86-13911992835
- Email: 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
-
-
Hunan
-
Changsha, Hunan, China, 410008
- Recruiting
- Xiangya Hospital, Central South University
-
Contact:
- Wei Wang, MD, PhD
- Phone Number: +86-13755030597
- Email: viviwang66@163.com
-
Contact:
- Xiang Ao, MD, PhD
- Phone Number: +86-13975806025
- Email: 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
-
-
Liaoning
-
Shenyang, Liaoning, China, 110001
- Recruiting
- The First Hospital of China Medical University
-
Contact:
- Li Yao, MD, PhD
- Phone Number: +86-13904035673
- Email: liyao_cmu@163.com
-
Sub-Investigator:
- Da Sun, MD, MM
-
Sub-Investigator:
- Wei Wu, BN
-
Sub-Investigator:
- Xiaoming Zhao, BN
-
Sub-Investigator:
- Yanan Sun, BN
-
-
Shannxi
-
Xi'an, Shannxi, China, 710000
- Recruiting
- The First Affiliated Hospital of Xi'an Jiaotong University
-
Contact:
- Jing Lv, MD, PhD
- Phone Number: +86-13096938232
- Email: drlvjing@163.com
-
Contact:
- Xiaopei Wang, MD, MM
- Phone Number: +86-18729306972
- Email: 1036654642@qq.com
-
Principal Investigator:
- Jing Lv, MD, PhD
-
Sub-Investigator:
- Yingzhou Geng, MD, MM
-
Sub-Investigator:
- Xiaopei Wang, MD, MM
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: APD group
Subjects will receive PD catheter placement and subsequent automated peritoneal dialysis treatment.
|
The prescription of automated peritoneal dialysis:
|
ACTIVE_COMPARATOR: IHD group
Subjects will receive un-tunneled hemodialysis catheter placement and subsequent 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
At 21 days after the initiation of dialysis
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At 21 days after the initiation of dialysis
|
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
|
At 90 days after the initiation of dialysis
|
Access related complications within 21 days
Time Frame: At 21 days after the initiation of dialysis
|
|
At 21 days after the initiation of dialysis
|
Access related complications within 90 days
Time Frame: At 90 days after the initiation of dialysis
|
|
At 90 days after the initiation of dialysis
|
Dialysis related complications within 21 days
Time Frame: At 21 days after the initiation of dialysis
|
Hypotension, hypoglycemia, bleeding, reactions to dialyzers, etc
|
At 21 days after the initiation of dialysis
|
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
|
At 90 days after the initiation of dialysis
|
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
|
From the time of admission to the time of discharge, up to 90 days
|
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.
|
At 21 days after the initiation of dialysis
|
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.
|
At 21 days after the initiation of dialysis
|
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.
|
At 21 days after the initiation of dialysis
|
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.
|
At 21 days after the initiation of dialysis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 24, 2018
Primary Completion (ANTICIPATED)
December 31, 2022
Study Completion (ANTICIPATED)
December 31, 2022
Study Registration Dates
First Submitted
June 10, 2018
First Submitted That Met QC Criteria
July 15, 2018
First Posted (ACTUAL)
July 26, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2022
Last Update Submitted That Met QC Criteria
February 5, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APD-AKI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
To comply with laws in China, local regulations and hospital policy, IPD sharing might be restricted
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Kidney Injury
-
Instituto Nacional de Cardiologia Ignacio ChavezInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUnknownKidney Injury, Acute | Acute Renal Injury | Acute Kidney Injuries | Kidney Injuries, Acute | Acute Renal InjuriesMexico
-
Yonsei UniversityCompletedAcute Kidney Injury(Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery)Korea, Republic of
-
University Hospital, GhentWithdrawn
-
Beni-Suef UniversityCairo UniversityRecruitingAKI - Acute Kidney InjuryEgypt
-
University Hospital MuensterBaxter Healthcare CorporationCompletedAcute Kidney Injury (AKI)Spain, France, United States, Turkey, Germany, Egypt, Italy, Libyan Arab Jamahiriya, Malta, North Macedonia, Palestinian Territory, occupied, Russian Federation, Saudi Arabia, Slovenia
-
Chinese PLA General HospitalBeijing Tsinghua Changgeng HospitalCompletedPostoperative Acute Kidney InjuryChina
-
Chinese PLA General HospitalCompletedPostoperative Acute Kidney InjuryChina
-
Ain Shams UniversityRecruiting
-
Astellas Pharma IncCompleted
-
South Egypt Cancer InstituteCompletedAcute Kidney Injury (AKI)Egypt
Clinical Trials on Automated peritoneal dialysis
-
Peking Union Medical College HospitalBeijing Anzhen Hospital; First Hospital of China Medical University; The Luhe... and other collaboratorsRecruiting
-
Fresenius Medical Care Deutschland GmbHCompletedChronic Renal FailureSpain, Sweden, Finland, Czechia, Denmark, Malaysia
-
Lund UniversityBaxter Healthcare Corporation; Universidad de CórdobaCompletedEnd Stage Kidney Disease | Chronic Kidney Disease Requiring Chronic DialysisArgentina
-
Chinese PLA General HospitalCompletedKidney Failure,ChronicChina
-
University of AlbertaWomen and Children's Health Research Institute, CanadaCompletedHypoplastic Left Heart SyndromeCanada
-
Universitaire Ziekenhuizen KU LeuvenCompletedChronic Kidney DiseaseBelgium
-
Baxter Healthcare CorporationCompletedEnd Stage Renal DiseaseChina
-
Chinese University of Hong KongCompletedRenal Failure | End-stage Renal DiseaseHong Kong
-
Princess Alexandra Hospital, Brisbane, AustraliaBaxter Healthcare CorporationCompletedKidney Failure, Chronic
-
Baxter Healthcare CorporationTerminatedEnd Stage Renal DiseaseChina