Clinical trial NCT03438877: Intensive Versus Regular Dosage For PD In AKI.
Official title: Intensive Versus Regular Dosage For Peritoneal Dialysis In Non-Hypercatabolic Acute Kidney Injury, A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peritoneal Dialysis
Acute Kidney Injury
Keywords: acute kidney injury
peritoneal dialysis
dosage
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 6
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Recruitment rate of the trial
timeFrame: From date of randomization until the randomization of last participant.
measure: Retention rate of the trial
timeFrame: From date of randomization until 90 days after the randomization of last participant
measure: Adherence rate of the trial
timeFrame: From date of randomization until 90 days after the randomization of last participant.
measure: Incidence of adverse events
timeFrame: From date of randomization until 90 days after the randomization of last participant.
Secondary outcomes:
measure: all cause mortality
timeFrame: 30-day, 60-day, 90-day after the patient enrolls in the study.
measure: The rate of renal recovery
timeFrame: 30-day, 60-day, 90-day after the patient enrolls in the study.
measure: length of hospital stay
timeFrame: 90 days of the study since the patient enrolls in the study
measure: Days for dialysis treatment
timeFrame: From date when a patient begins peritoneal dialysis until the date of dialysis withdrawal, assessed up to 90 days.
measure: Incidence of dialysis transferring
timeFrame: At 90 days after patient enrolls in the study
measure: Incidence of comorbidities
timeFrame: At 90 days after patient enrolls in the study
measure: in-hospital cost
timeFrame: At 90 days after patient enrolls in the study
Other outcomes:
Locations:
city: Beijing
country: China
facility: Renal Division and Institute of Nephrology, Peking University First Hospital
state: Beijing
city: Cangzhou
country: China
facility: Cangzhou central hospital
state: Hebei
city: Nanyang
country: China
facility: Nanyang City Center Hospital
state: Henan
city: Pingdingshan
country: China
facility: Pingdingshan People's Hospital No.1
state: Henan
city: Enshi
country: China
facility: Minda Hospital of Hubei Minzu University
state: Hubei
city: Yichang
country: China
facility: Yichang Central People's Hospital
state: Hubei
city: Chuxiong
country: China
facility: The People's Hospital of Chuxiong Yi Autonomous Prefecture
state: Yunnan
Study officials:
affiliation: Peking Universiy First Hospital
name: Jie Dong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.