Back to results

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

Primary Purpose

Acute Kidney Injury

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Automated peritoneal dialysis

Intermittent hemodialysis

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring acute kidney injury, automated peritoneal dialysis, intermittent hemodialysis, renal recovery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Beijing Anzhen Hospital, Capital Medical UniversityRecruiting
Peking Union Medical College HospitalRecruiting
Xiangya Hospital, Central South UniversityRecruiting
The First Hospital of China Medical UniversityRecruiting
The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

APD group

IHD group

Arm Description

Subjects will receive PD catheter placement and subsequent automated peritoneal dialysis treatment.

Subjects will receive un-tunneled hemodialysis catheter placement and subsequent intermittent hemodialysis.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

All-cause mortality within 21 days

The rate of all-cause of deaths 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

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

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

Dialysis related complications within 21 days

Hypotension, hypoglycemia, bleeding, reactions to dialyzers, etc

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

Length of stay in hospital

The time length of stay as an inpatient

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.

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.

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.

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.

Full Information

NCT ID

NCT03598387

First Posted

June 10, 2018

Last Updated

February 5, 2022

Sponsor

Limeng Chen

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

1. Study Identification

Unique Protocol Identification Number

NCT03598387

Brief Title

Automated Peritoneal Dialysis Versus Intermittent Hemodialysis in Acute Kidney Injury

Acronym

SAFE-APD

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 24, 2018 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Limeng Chen

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Injury

Keywords

acute kidney injury, automated peritoneal dialysis, intermittent hemodialysis, renal recovery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

APD group

Arm Type

Experimental

Arm Description

Subjects will receive PD catheter placement and subsequent automated peritoneal dialysis treatment.

Arm Title

IHD group

Arm Type

Active Comparator

Arm Description

Subjects will receive un-tunneled hemodialysis catheter placement and subsequent intermittent hemodialysis.

Intervention Type

Other

Intervention Name(s)

Automated peritoneal dialysis

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Intermittent hemodialysis

Intervention Description

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.

Primary Outcome Measure Information:

Title

The rate of renal function recovery (independence of dialysis)

Description

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

Secondary Outcome Measure Information:

Title

All-cause mortality within 21 days

Description

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

Title

All-cause mortality within 90 days

Description

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

Title

Access related complications within 21 days

Description

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

Title

Access related complications within 90 days

Description

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

Title

Dialysis related complications within 21 days

Description

Hypotension, hypoglycemia, bleeding, reactions to dialyzers, etc

Time Frame

At 21 days after the initiation of dialysis

Title

The percentage of participants requiring termination of primary dialysis modality

Description

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

Title

Length of stay in hospital

Description

The time length of stay as an inpatient

Time Frame

From the time of admission to the time of discharge, up to 90 days

Title

Herth Hope Index within 21 days

Description

Time Frame

At 21 days after the initiation of dialysis

Title

Health Status Questionnaire (Short Form-36) score within 21 days

Description

Time Frame

At 21 days after the initiation of dialysis

Title

Mini-Mental State Examination (MMSE) score within 21 days

Description

Time Frame

At 21 days after the initiation of dialysis

Title

Simplified Nutritional Appetite Questionnaire (SNAQ) score within 21 days

Description

Time Frame

At 21 days after the initiation of dialysis

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Peng Xia, MD

Phone

+86-13811684903

7-xp@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ying Wang, MD, PhD

Phone

+86-18600930725

pumchwy@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Limeng Chen, MD, PhD

Organizational Affiliation

Division of Nephrology, Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Anzhen Hospital, Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100029

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guoqin Wang, MD, PhD

Phone

+86-13911282575

wangguoqin1@163.com

First Name & Middle Initial & Last Name & Degree

Yumeng Zhang, BN

Phone

+86-13911992835

791751665@qq.com

First Name & Middle Initial & Last Name & Degree

Hong Cheng, MD, PhD

First Name & Middle Initial & Last Name & Degree

Guoqin Wang, MD, PhD

First Name & Middle Initial & Last Name & Degree

Zhirui Zhao, MD

First Name & Middle Initial & Last Name & Degree

Yu Wang, BN

First Name & Middle Initial & Last Name & Degree

Yumeng Zhang, BN

Facility Name

Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peng Xia, MD

Phone

+86-13811684903

7-xp@163.com

First Name & Middle Initial & Last Name & Degree

Ying Wang, MD, PhD

Phone

+86-18600930725

pumchwy@163.com

First Name & Middle Initial & Last Name & Degree

Limeng Chen, MD, PhD

First Name & Middle Initial & Last Name & Degree

Xuemei Li, MD, PhD

First Name & Middle Initial & Last Name & Degree

Peng Xia, MD

First Name & Middle Initial & Last Name & Degree

Ying Wang, MD, PhD

First Name & Middle Initial & Last Name & Degree

Haiyun Wang, MD, PhD

First Name & Middle Initial & Last Name & Degree

Bingyan Liu, MD, PhD

First Name & Middle Initial & Last Name & Degree

Zijuan Zhou, BN

Facility Name

Xiangya Hospital, Central South University

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410008

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wei Wang, MD, PhD

Phone

+86-13755030597

viviwang66@163.com

First Name & Middle Initial & Last Name & Degree

Xiang Ao, MD, PhD

Phone

+86-13975806025

2403980692@qq.com

First Name & Middle Initial & Last Name & Degree

Xiang Ao, MD, PhD

First Name & Middle Initial & Last Name & Degree

Xiangcheng Xiao, MD, PhD

First Name & Middle Initial & Last Name & Degree

Wei Wang, MD, PhD

First Name & Middle Initial & Last Name & Degree

Wannian Nie, MD, MM

First Name & Middle Initial & Last Name & Degree

Jing Li, MD, MM

First Name & Middle Initial & Last Name & Degree

Zhu Wang, MD

First Name & Middle Initial & Last Name & Degree

Fangfang Ye, MD

First Name & Middle Initial & Last Name & Degree

Min Zhang, MD

Facility Name

The First Hospital of China Medical University

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110001

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Li Yao, MD, PhD

Phone

+86-13904035673

liyao_cmu@163.com

First Name & Middle Initial & Last Name & Degree

Xinwang Zhu, MD, PhD

Phone

+86-13804056472

zhuxinwang_cmu@126.com

First Name & Middle Initial & Last Name & Degree

Li Yao, MD, PhD

First Name & Middle Initial & Last Name & Degree

Xinwang Zhu, MD, PhD

First Name & Middle Initial & Last Name & Degree

Da Sun, MD, MM

First Name & Middle Initial & Last Name & Degree

Wei Wu, BN

First Name & Middle Initial & Last Name & Degree

Xiaoming Zhao, BN

First Name & Middle Initial & Last Name & Degree

Yanan Sun, BN

Facility Name

The First Affiliated Hospital of Xi'an Jiaotong University

City

Xi'an

State/Province

Shannxi

ZIP/Postal Code

710000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jing Lv, MD, PhD

Phone

+86-13096938232

drlvjing@163.com

First Name & Middle Initial & Last Name & Degree

Xiaopei Wang, MD, MM

Phone

+86-18729306972

1036654642@qq.com

First Name & Middle Initial & Last Name & Degree

Jing Lv, MD, PhD

First Name & Middle Initial & Last Name & Degree

Yingzhou Geng, MD, MM

First Name & Middle Initial & Last Name & Degree

Xiaopei Wang, MD, MM

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

To comply with laws in China, local regulations and hospital policy, IPD sharing might be restricted

Citations:

PubMed Identifier

16928612

Citation

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.

Results Reference

background

PubMed Identifier

18379555

Citation

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.

Results Reference

background

Learn more about this trial

Automated Peritoneal Dialysis Versus Intermittent Hemodialysis in Acute Kidney Injury

We'll reach out to this number within 24 hrs