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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
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.
Renal Division and Institute of Nephrology, Peking University First Hospital
Beijing, Beijing Municipality, China
Cangzhou central hospital
Cangzhou, Hebei, China
Nanyang City Center Hospital
Nanyang, Henan, China
Pingdingshan People's Hospital No.1
Pingdingshan, Henan, China
Recruitment rate of the trial
Recruitment rate of patients screened for the trial measured by percentage.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: From date of randomization until 90 days after the randomization of last participant.
all cause mortality
mortality due to all causes
Time frame: 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.
Time frame: 30-day, 60-day, 90-day after the patient enrolls in the study.
length of hospital stay
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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
total days for hospital stay
Time frame: 90 days of the study since the patient enrolls in the study
Days for dialysis treatment
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.
Incidence of dialysis transferring
Incidence of dialysis transferring from PD to HD
Time frame: 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
Time frame: At 90 days after patient enrolls in the study
in-hospital cost
in-hospital cost, including expenses of examinations, treatments and manpower cost.
Time frame: At 90 days after patient enrolls in the study