Acute Kidney InjurySAFE-APDNCT03598387
Automated Peritoneal Dialysis Versus Intermittent Hemodialysis in Acute Kidney Injury
A study testing Automated peritoneal dialysis and Intermittent hemodialysis in people with Acute Kidney Injury, run by Limeng Chen at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Automated peritoneal dialysis and Intermittent hemodialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesChina
- Study dates
- 24 Apr 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Guoqin Wang, MD, PhD, +86-13911282575, wangguoqin1@163.com
Yumeng Zhang, BN, +86-13911992835, 791751665@qq.com
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Peng Xia, MD, +86-13811684903, 7-xp@163.com
Ying Wang, MD, PhD, +86-18600930725, pumchwy@163.com
- Recruiting
Xiangya Hospital, Central South University
Changsha, Hunan, 410008
Wei Wang, MD, PhD, +86-13755030597, viviwang66@163.com
Xiang Ao, MD, PhD, +86-13975806025, 2403980692@qq.com
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Li Yao, MD, PhD, +86-13904035673, liyao_cmu@163.com
Xinwang Zhu, MD, PhD, +86-13804056472, zhuxinwang_cmu@126.com
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shannxi, 710000
Jing Lv, MD, PhD, +86-13096938232, drlvjing@163.com
Xiaopei Wang, MD, MM, +86-18729306972, 1036654642@qq.com
About this study
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
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.
Read the 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.
- Conditions
- Acute Kidney Injury
- Being tested
- Automated peritoneal dialysis, Intermittent hemodialysis
- Keywords
- acute kidney injury, automated peritoneal dialysis, intermittent hemodialysis, renal recovery
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated peritoneal dialysisOther
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 hemodialysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| APD group | Experimental | Subjects will receive PD catheter placement and subsequent automated peritoneal dialysis treatment. Receives: Other: Automated peritoneal dialysis |
| IHD group | Active comparator | Subjects will receive un-tunneled hemodialysis catheter placement and subsequent intermittent hemodialysis. Receives: Other: Intermittent hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At 21 days after the initiation of dialysis
Secondary outcomes (11)
All-cause mortality within 21 days
The rate of all-cause of deaths at 21 days after the initiation of dialysis
Measured: 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
Measured: 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
Measured: 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
Measured: At 90 days after the initiation of dialysis
Dialysis related complications within 21 days
Hypotension, hypoglycemia, bleeding, reactions to dialyzers, etc
Measured: 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
Measured: At 90 days after the initiation of dialysis
Length of stay in hospital
The time length of stay as an inpatient
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 21 days after the initiation of dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start24 Apr 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Limeng Chen
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor-investigator, Limeng Chen, Peking Union Medical College Hospital
- Investigators
- Limeng Chen, MD, PhD, Principal investigator, Division of Nephrology, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598387
- Sponsor's protocol ID
- APD-AKI
- Acronym
- SAFE-APD
- Status last verified
- Feb 2022
- First submitted
- 10 Jun 2018
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To comply with laws in China, local regulations and hospital policy, IPD sharing might be restricted
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.
PubMed 16928612Gabriel 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.
PubMed 18379555
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03598387
- Acronym / sponsor ID
- SAFE-APD / APD-AKI
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, automated peritoneal dialysis, intermittent hemodialysis, renal recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Limeng ChenUniversity, hospital or other
- 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
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| APD group | Experimental | Other: Automated peritoneal dialysisSubjects will receive PD catheter placement and subsequent automated peritoneal dialysis treatment. |
| IHD group | Active comparator | Other: Intermittent hemodialysisSubjects will receive un-tunneled hemodialysis catheter placement and subsequent intermittent hemodialysis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated peritoneal dialysisThe 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. | Other | APD group |
| Intermittent hemodialysisIntermittent 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. | Other | IHD group |
Primary outcome
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).
11 secondary outcomes
All-cause mortality within 21 days
Time frame: At 21 days after the initiation of dialysis
All-cause mortality within 90 days
Time frame: At 90 days after the initiation of dialysis
Access related complications within 21 days
Time frame: At 21 days after the initiation of dialysis
Access related complications within 90 days
Time frame: At 90 days after the initiation of dialysis
Dialysis related complications within 21 days
Time frame: 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
Length of stay in hospital
Time frame: 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
Health Status Questionnaire (Short Form-36) score within 21 days
Time frame: 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
Simplified Nutritional Appetite Questionnaire (SNAQ) score within 21 days
Time frame: At 21 days after the initiation of dialysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Background: PubMed 16928612Gabriel 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.
- Background: PubMed 18379555Gabriel 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.
- Individual participant dataSharing planned: No. To comply with laws in China, local regulations and hospital policy, IPD sharing might be restricted
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Limeng Chen, MD, PhD principal investigator
Division of Nephrology, Peking Union Medical College Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated peritoneal dialysis and Intermittent hemodialysis in people with Acute Kidney Injury, run by Limeng Chen at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peng Xia, MD (+86-13811684903, 7-xp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of renal function recovery (independence of dialysis) (time frame: At 21 days after the initiation of dialysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03598387, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.