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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ying Wang, MD, PhD
  • Phone Number: +86-18600930725
  • Email: pumchwy@163.com

Study Locations

  • China
    • 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:
      • Beijing, Beijing, China, 100029
        • Recruiting
        • Beijing AnZhen Hospital, Capital Medical University
        • Contact:
        • Contact:
        • 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:
        • Contact:
        • 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:
        • 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:
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
  • Infections: peritonitis (APD), catheter-related infections (IHD)
  • Mechanical complications: catheter leakage and migration (APD), catheter obstruction (IHD)
  • Exit site bleeding, pneumothorax, hernia
At 21 days after the initiation of dialysis
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
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Limeng Chen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Xiangya Hospital of Central South University
Baxter Healthcare Corporation
First Affiliated Hospital Xi'an Jiaotong University
Beijing Anzhen Hospital
First Hospital of China Medical University

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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