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Intensive Versus Regular Dosage For PD In AKI.

Primary Purpose

Peritoneal Dialysis, Acute Kidney Injury

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intensive dosage of PD
Regular dosage of PD
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritoneal Dialysis focused on measuring acute kidney injury, peritoneal dialysis, dosage

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age older than 14 years;
  • Be diagnosed as AKI according to KDIGO recommendation;
  • Having indications for renal replacement therapy.

Exclusion Criteria:

  • Having contraindications to peritoneal dialysis;
  • Functional azotemia;
  • Hypercatabolic status;
  • Previous CKD history (baseline eGFR<60ml/min/1.73m2 or proteinuria);
  • Psychological disorder or communication barrier;
  • Pregnancy;
  • Refusing to receive dialysis therapy.
  • receiving mechanical ventilation.

Sites / Locations

  • Renal Division and Institute of Nephrology, Peking University First Hospital
  • Cangzhou central hospital
  • Nanyang City Center Hospital
  • Pingdingshan People's Hospital No.1
  • Minda Hospital of Hubei Minzu University
  • Yichang Central People's Hospital
  • The People's Hospital of Chuxiong Yi Autonomous Prefecture

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

Intervention group is intensive dosage of PD.

Control group is regular dosage of PD.

Outcomes

Primary Outcome Measures

Recruitment rate of the trial
Recruitment rate of patients screened for the trial measured by percentage.
Retention rate of the trial
Retention rate of included patients in the trial measured by percentage.
Adherence rate of the trial
Percentage of participants adherent to the dosing regimen of PDDOSE study.
Incidence of adverse events
Incidence of adverse events measured by number of events per patient-month

Secondary Outcome Measures

all cause mortality
mortality due to all causes
The rate of renal recovery
We defined renal recovery as full recovery with serum creatinine decreased to below threshold or to the baseline after dialysis withdrawal . We defined partial recovery as serum creatinine decreased by 25% or more from peak concentration but remaining higher than the threshold or baseline after dialysis withdrawal. We defined failure to recover as patient still dependent on dialysis.
length of hospital stay
total days for hospital stay
Days for dialysis treatment
Days for dialysis treatment, including PD and HD
Incidence of dialysis transferring
Incidence of dialysis transferring from PD to HD
Incidence of comorbidities
Incidence of comorbidities, including patient's new onset comorbidities and PD-associated technique comorbidities
in-hospital cost
in-hospital cost, including expenses of examinations, treatments and manpower cost.

Full Information

First Posted
February 8, 2018
Last Updated
November 24, 2021
Sponsor
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03438877
Brief Title
Intensive Versus Regular Dosage For PD In AKI.
Official Title
Intensive Versus Regular Dosage For Peritoneal Dialysis In Non-Hypercatabolic Acute Kidney Injury, A Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
Patients recruited difficult.
Study Start Date
September 29, 2018 (Actual)
Primary Completion Date
December 26, 2019 (Actual)
Study Completion Date
December 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multicenter, pilot RCT study, aiming to compare intensive dosage and regular dosage of PD for AKI patients with indications for dialysis. Aims of the study are to: Examine the feasibility of the study, which aims to determine the efficacy and safety of intensive PD dose for AKI patients as compared to regular PD dose. Establish the appropriate workflow for PD treatment for AKI patients.
Detailed Description
The incidence of acute kidney injury (AKI) is rapidly increasing worldwide, which partly due to greater recognition of AKI, more exposure to various nephrotoxins and an ageing population with increased burden of non-infectious chronic disease. Intermittent hemodialysis (IHD) or continuous renal replacement therapy (CRRT) (i.e. venous-venous HD or hemofiltration) are the most-commonly modalities applied for acute kidney injury (AKI) patients in both developed and developing countries. By contrast, the use of peritoneal dialysis (PD) has been rare. There are no consensus on the ideal dosage and target of adequacy for PD in AKI. Therefore, we are to perform a multicenter, pilot RCT study, aiming to compare intensive dosage and regular dosage of PD for AKI patients with indications for dialysis. If successful, this strategy is expected to enhance the remedy rate of AKF patients, especially in developing regions/countries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Dialysis, Acute Kidney Injury
Keywords
acute kidney injury, peritoneal dialysis, dosage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Intervention group is intensive dosage of PD.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Control group is regular dosage of PD.
Intervention Type
Procedure
Intervention Name(s)
Intensive dosage of PD
Other Intervention Name(s)
intensive PD
Intervention Description
Within the first month since PD initiates, PD prescription will be adjusted to achieve the minimum target of 3.5. It's anticipated to prescribe the dosage with automatic PD (APD) or manual PD as 24-36L/day of dialysate, 1.5-2L/exchange, and 16 cycles. Anyway, it depends on the characteristics of the patients, including residual renal function, peritoneal memberane properties. The Kt/V goal will be compromised by clinical assessment for the patient, which means PD will not induce additional treatment, such as fluid infusion.
Intervention Type
Procedure
Intervention Name(s)
Regular dosage of PD
Other Intervention Name(s)
regular PD
Intervention Description
Within the first month since PD initiates, PD prescription will be adjusted to achieve the minimum target of 2.1. It's anticipated to prescribe the dosage with automatic PD (APD) or manual PD as 9-12L/day of dialysate, 1.5-2L/exchange, and 6 cycles. Anyway, it depends on the characteristics of the patients, including residual renal function, peritoneal memberane properties. The Kt/V goal will be compromised by clinical assessment for the patient, which means PD will not induce additional treatment, such as fluid infusion.
Primary Outcome Measure Information:
Title
Recruitment rate of the trial
Description
Recruitment rate of patients screened for the trial measured by percentage.
Time Frame
From date of randomization until the randomization of last participant.
Title
Retention rate of the trial
Description
Retention rate of included patients in the trial measured by percentage.
Time Frame
From date of randomization until 90 days after the randomization of last participant
Title
Adherence rate of the trial
Description
Percentage of participants adherent to the dosing regimen of PDDOSE study.
Time Frame
From date of randomization until 90 days after the randomization of last participant.
Title
Incidence of adverse events
Description
Incidence of adverse events measured by number of events per patient-month
Time Frame
From date of randomization until 90 days after the randomization of last participant.
Secondary Outcome Measure Information:
Title
all cause mortality
Description
mortality due to all causes
Time Frame
30-day, 60-day, 90-day after the patient enrolls in the study.
Title
The rate of renal recovery
Description
We defined renal recovery as full recovery with serum creatinine decreased to below threshold or to the baseline after dialysis withdrawal . We defined partial recovery as serum creatinine decreased by 25% or more from peak concentration but remaining higher than the threshold or baseline after dialysis withdrawal. We defined failure to recover as patient still dependent on dialysis.
Time Frame
30-day, 60-day, 90-day after the patient enrolls in the study.
Title
length of hospital stay
Description
total days for hospital stay
Time Frame
90 days of the study since the patient enrolls in the study
Title
Days for dialysis treatment
Description
Days for dialysis treatment, including PD and HD
Time Frame
From date when a patient begins peritoneal dialysis until the date of dialysis withdrawal, assessed up to 90 days.
Title
Incidence of dialysis transferring
Description
Incidence of dialysis transferring from PD to HD
Time Frame
At 90 days after patient enrolls in the study
Title
Incidence of comorbidities
Description
Incidence of comorbidities, including patient's new onset comorbidities and PD-associated technique comorbidities
Time Frame
At 90 days after patient enrolls in the study
Title
in-hospital cost
Description
in-hospital cost, including expenses of examinations, treatments and manpower cost.
Time Frame
At 90 days after patient enrolls in the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age older than 14 years; Be diagnosed as AKI according to KDIGO recommendation; Having indications for renal replacement therapy. Exclusion Criteria: Having contraindications to peritoneal dialysis; Functional azotemia; Hypercatabolic status; Previous CKD history (baseline eGFR<60ml/min/1.73m2 or proteinuria); Psychological disorder or communication barrier; Pregnancy; Refusing to receive dialysis therapy. receiving mechanical ventilation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Dong, PhD
Organizational Affiliation
Peking Universiy First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renal Division and Institute of Nephrology, Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Cangzhou central hospital
City
Cangzhou
State/Province
Hebei
Country
China
Facility Name
Nanyang City Center Hospital
City
Nanyang
State/Province
Henan
Country
China
Facility Name
Pingdingshan People's Hospital No.1
City
Pingdingshan
State/Province
Henan
Country
China
Facility Name
Minda Hospital of Hubei Minzu University
City
Enshi
State/Province
Hubei
Country
China
Facility Name
Yichang Central People's Hospital
City
Yichang
State/Province
Hubei
Country
China
Facility Name
The People's Hospital of Chuxiong Yi Autonomous Prefecture
City
Chuxiong
State/Province
Yunnan
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25074995
Citation
Cullis B, Abdelraheem M, Abrahams G, Balbi A, Cruz DN, Frishberg Y, Koch V, McCulloch M, Numanoglu A, Nourse P, Pecoits-Filho R, Ponce D, Warady B, Yeates K, Finkelstein FO. Peritoneal dialysis for acute kidney injury. Perit Dial Int. 2014 Jul-Aug;34(5):494-517. doi: 10.3747/pdi.2013.00222. No abstract available.
Results Reference
result

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Intensive Versus Regular Dosage For PD In AKI.

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