Intensive Versus Regular Dosage For PD In AKI.

Not Applicable

Terminated

• Conditions: Acute Kidney Injury; Peritoneal Dialysis
• Interventions: Procedure: Intensive dosage of PD; Procedure: Regular dosage of PD

• Registration Number: NCT03438877
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-17
• Study First Posted: 2018-02-20
• Study Start: 2018-09-29
• Primary Completion: 2019-12-26
• Study Completion: 2019-12-26
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-24
• Last Update Posted: 2021-12-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Intensive dosage of PD	Intervention group is intensive dosage of PD.
Control group	Regular dosage of PD	Control group is regular dosage of PD.

Primary Outcome Measures

Name	Time	Method
Recruitment rate of the trial	From date of randomization until the randomization of last participant.	Recruitment rate of patients screened for the trial measured by percentage.
Retention rate of the trial	From date of randomization until 90 days after the randomization of last participant	Retention rate of included patients in the trial measured by percentage.
Incidence of adverse events	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
Adherence rate of the trial	From date of randomization until 90 days after the randomization of last participant.	Percentage of participants adherent to the dosing regimen of PDDOSE study.

Secondary Outcome Measures

Name	Time	Method
all cause mortality	30-day, 60-day, 90-day after the patient enrolls in the study.	mortality due to all causes
length of hospital stay	90 days of the study since the patient enrolls in the study	total days for hospital stay
The rate of renal recovery	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.
Days for dialysis treatment	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
Incidence of dialysis transferring	At 90 days after patient enrolls in the study	Incidence of dialysis transferring from PD to HD
Incidence of comorbidities	At 90 days after patient enrolls in the study	Incidence of comorbidities, including patient's new onset comorbidities and PD-associated technique comorbidities
in-hospital cost	At 90 days after patient enrolls in the study	in-hospital cost, including expenses of examinations, treatments and manpower cost.

Trial Locations

Locations (7)

Renal Division and Institute of Nephrology, Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

Nanyang City Center Hospital; 🇨🇳 Nanyang, Henan, China

Cangzhou central hospital; 🇨🇳 Cangzhou, Hebei, China

Pingdingshan People's Hospital No.1; 🇨🇳 Pingdingshan, Henan, China

Minda Hospital of Hubei Minzu University; 🇨🇳 Enshi, Hubei, China

The People's Hospital of Chuxiong Yi Autonomous Prefecture; 🇨🇳 Chuxiong, Yunnan, China

Yichang Central People's Hospital; 🇨🇳 Yichang, Hubei, China