Intensive Versus Regular Dosage For PD In AKI.

Intensive Versus Regular Dosage For Peritoneal Dialysis In Non-Hypercatabolic Acute Kidney Injury, A Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Peritoneal Dialysis; Acute Kidney Injury
• Intervention / Treatment: Procedure: Intensive dosage of PD; Procedure: Regular dosage of PD

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Renal Division and Institute of Nephrology, Peking University First Hospital
  • Hebei
    • Cangzhou, Hebei, China
      • Cangzhou Central Hospital
  • Henan
    • Nanyang, Henan, China
      • Nanyang City Center Hospital
    • Pingdingshan, Henan, China
      • Pingdingshan People's Hospital No.1
  • Hubei
    • Enshi, Hubei, China
      • Minda Hospital of Hubei Minzu University
    • Yichang, Hubei, China
      • Yichang Central People's Hospital
  • Yunnan
    • Chuxiong, Yunnan, China
      • The People's Hospital of Chuxiong Yi Autonomous Prefecture

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: regular PD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
all cause mortality	mortality due to all causes	30-day, 60-day, 90-day after the patient enrolls in the study.
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.	30-day, 60-day, 90-day after the patient enrolls in the study.
length of hospital stay	total days for hospital stay	90 days of the study since the patient enrolls in the study
Days for dialysis treatment	Days for dialysis treatment, including PD and HD	From date when a patient begins peritoneal dialysis until the date of dialysis withdrawal, assessed up to 90 days.
Incidence of dialysis transferring	Incidence of dialysis transferring from PD to HD	At 90 days after patient enrolls in the study
Incidence of comorbidities	Incidence of comorbidities, including patient's new onset comorbidities and PD-associated technique comorbidities	At 90 days after patient enrolls in the study
in-hospital cost	in-hospital cost, including expenses of examinations, treatments and manpower cost.	At 90 days after patient enrolls in the study

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Investigators: Principal Investigator: Jie Dong, PhD, Peking Universiy First Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2018
• Primary Completion (Actual): December 26, 2019
• Study Completion (Actual): December 26, 2019

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 17, 2018
• First Posted (Actual): February 20, 2018

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: acute kidney injury; peritoneal dialysis; dosage
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: PDDOSE study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No