Study Stopped
Patients recruited difficult.
Intensive Versus Regular Dosage For PD In AKI.
1 other identifier
interventional
6
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2018
CompletedFirst Posted
Study publicly available on registry
February 20, 2018
CompletedStudy Start
First participant enrolled
September 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 26, 2019
CompletedDecember 8, 2021
November 1, 2021
1.2 years
February 8, 2018
November 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Recruitment rate of the trial
Recruitment rate of patients screened for the trial measured by percentage.
From date of randomization until the randomization of last participant.
Retention rate of the trial
Retention rate of included patients in the trial measured by percentage.
From date of randomization until 90 days after the randomization of last participant
Adherence rate of the trial
Percentage of participants adherent to the dosing regimen of PDDOSE study.
From date of randomization until 90 days after the randomization of last participant.
Incidence of adverse events
Incidence of adverse events measured by number of events per patient-month
From date of randomization until 90 days after the randomization of last participant.
Secondary Outcomes (7)
all cause mortality
30-day, 60-day, 90-day after the patient enrolls in the study.
The rate of renal recovery
30-day, 60-day, 90-day after the patient enrolls in the study.
length of hospital stay
90 days of the study since the patient enrolls in the study
Days for dialysis treatment
From date when a patient begins peritoneal dialysis until the date of dialysis withdrawal, assessed up to 90 days.
Incidence of dialysis transferring
At 90 days after patient enrolls in the study
- +2 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALIntervention group is intensive dosage of PD.
Control group
ACTIVE COMPARATORControl group is regular dosage of PD.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age older than 14 years;
- Be diagnosed as AKI according to KDIGO recommendation;
- Having indications for renal replacement therapy.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Renal Division and Institute of Nephrology, Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Cangzhou central hospital
Cangzhou, Hebei, China
Nanyang City Center Hospital
Nanyang, Henan, China
Pingdingshan People's Hospital No.1
Pingdingshan, Henan, China
Minda Hospital of Hubei Minzu University
Enshi, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
The People's Hospital of Chuxiong Yi Autonomous Prefecture
Chuxiong, Yunnan, China
Related Publications (1)
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.
PMID: 25074995RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jie Dong, PhD
Peking Universiy First Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of PD center
Study Record Dates
First Submitted
February 8, 2018
First Posted
February 20, 2018
Study Start
September 29, 2018
Primary Completion
December 26, 2019
Study Completion
December 26, 2019
Last Updated
December 8, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share