Intensive Versus Regular Dosage For PD In AKI.

Peking University

Status: Terminated

Conditions: Acute Kidney Injury; Peritoneal Dialysis

Treatments: Procedure: Regular dosage of PD; Procedure: Intensive dosage of PD

Study type: Interventional

Funder types: Other

Identifiers

NCT03438877

PDDOSE study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Intervention group

Experimental group

Description:

Intervention group is intensive dosage of PD.

Treatment:

Procedure: Intensive dosage of PD

Control group

Active Comparator group

Description:

Control group is regular dosage of PD.

Treatment:

Procedure: Regular dosage of PD