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Intensive Versus Regular Dosage For PD In AKI.

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ClinicalTrials.gov Identifier: NCT03438877
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Dong Jie, Peking University First Hospital

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.


Condition or disease Intervention/treatment Phase
Peritoneal Dialysis Acute Kidney Injury Procedure: Intensive dosage of PD Procedure: Regular dosage of PD Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensive Versus Regular Dosage For Peritoneal Dialysis In Non-Hypercatabolic Acute Kidney Injury, A Multicenter Randomized Controlled Trial
Actual Study Start Date : September 29, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Intervention group
Intervention group is intensive dosage of PD.
Procedure: Intensive dosage of PD
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.
Other Name: intensive PD

Active Comparator: Control group
Control group is regular dosage of PD.
Procedure: Regular dosage of PD
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.
Other Name: regular PD




Primary Outcome Measures :
  1. Recruitment rate of the trial [ Time Frame: From date of randomization until the randomization of last participant. ]
    Recruitment rate of patients screened for the trial measured by percentage.

  2. Retention rate of the trial [ Time Frame: From date of randomization until 90 days after the randomization of last participant ]
    Retention rate of included patients in the trial measured by percentage.

  3. Adherence rate of the trial [ Time Frame: From date of randomization until 90 days after the randomization of last participant. ]
    Percentage of participants adherent to the dosing regimen of PDDOSE study.

  4. Incidence of adverse events [ Time Frame: From date of randomization until 90 days after the randomization of last participant. ]
    Incidence of adverse events measured by number of events per patient-month


Secondary Outcome Measures :
  1. all cause mortality [ Time Frame: 30-day, 60-day, 90-day after the patient enrolls in the study. ]
    mortality due to all causes

  2. The rate of renal recovery [ Time Frame: 30-day, 60-day, 90-day after the patient enrolls in the study. ]
    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.

  3. length of hospital stay [ Time Frame: 90 days of the study since the patient enrolls in the study ]
    total days for hospital stay

  4. Days for dialysis treatment [ Time Frame: From date when a patient begins peritoneal dialysis until the date of dialysis withdrawal, assessed up to 90 days. ]
    Days for dialysis treatment, including PD and HD

  5. Incidence of dialysis transferring [ Time Frame: At 90 days after patient enrolls in the study ]
    Incidence of dialysis transferring from PD to HD

  6. Incidence of comorbidities [ Time Frame: At 90 days after patient enrolls in the study ]
    Incidence of comorbidities, including patient's new onset comorbidities and PD-associated technique comorbidities

  7. in-hospital cost [ Time Frame: At 90 days after patient enrolls in the study ]
    in-hospital cost, including expenses of examinations, treatments and manpower cost.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438877


Contacts
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Contact: Jie Dong, PhD +8601083572532 jie.dong@bjmu.edu.cn

Locations
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China, Beijing
Renal Division and Institute of Nephrology, Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Jie Dong, MD    086-010-83572388    dongjie@bjmu.edu.cn   
Sub-Investigator: Zhikai Yang, MD         
Principal Investigator: Jie Dong, MD         
China, Hebei
Cangzhou central hospital Recruiting
Cangzhou, Hebei, China
Contact: Nan Zhao, MD         
China, Henan
Nanyang City Center Hospital Recruiting
Nanyang, Henan, China
Contact: Dongsheng Ren, MD         
Pingdingshan People's Hospital No.1 Recruiting
Pingdingshan, Henan, China
Contact: Xianzhao Zhang, MD         
China, Hubei
Minda Hospital of Hubei Minzu University Active, not recruiting
Enshi, Hubei, China
Yichang Central People's Hospital Active, not recruiting
Yichang, Hubei, China
China, Yunnan
The People's Hospital of Chuxiong Yi Autonomous Prefecture Recruiting
Chuxiong, Yunnan, China
Contact: Wenxi Zhao, MD         
Sponsors and Collaborators
Peking University First Hospital
Investigators
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Principal Investigator: Jie Dong, PhD Peking Universiy First Hospital
Publications of Results:
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Responsible Party: Dong Jie, Director of PD center, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03438877    
Other Study ID Numbers: PDDOSE study
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dong Jie, Peking University First Hospital:
acute kidney injury
peritoneal dialysis
dosage
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases