NCT03598387

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 8, 2022

Status Verified

February 1, 2022

Enrollment Period

4.7 years

First QC Date

June 10, 2018

Last Update Submit

February 5, 2022

Conditions

Acute Kidney Injury

Keywords

acute kidney injuryautomated peritoneal dialysisintermittent hemodialysisrenal recovery

Outcome Measures

Primary Outcomes (1)

  • 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).

    At 21 days after the initiation of dialysis

Secondary Outcomes (11)

  • All-cause mortality within 21 days

    At 21 days after the initiation of dialysis

  • All-cause mortality within 90 days

    At 90 days after the initiation of dialysis

  • Access related complications within 21 days

    At 21 days after the initiation of dialysis

  • Access related complications within 90 days

    At 90 days after the initiation of dialysis

  • Dialysis related complications within 21 days

    At 21 days after the initiation of dialysis

  • +6 more secondary outcomes

Study Arms (2)

APD group

EXPERIMENTAL

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

Other: Automated peritoneal dialysis

IHD group

ACTIVE COMPARATOR

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

Other: Intermittent hemodialysis

Interventions

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.

APD group
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.

IHD group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shannxi, 710000, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 16928612BACKGROUND

  • 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.

    PMID: 18379555BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Limeng Chen, MD, PhD

    Division of Nephrology, Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Xia, MD

CONTACT

+86-138116849037-xp@163.com

Ying Wang, MD, PhD

CONTACT

+86-18600930725pumchwy@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine, Associate Chief of Nephrology Division

Study Record Dates

First Submitted

June 10, 2018

First Posted

July 26, 2018

Study Start

April 24, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 8, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

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

Locations

CN(5)