Intensive Versus Regular Dosage For PD In AKI.

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03438877
• Other study ID #: PDDOSE study
• Status: Terminated
• Phase: N/A
• Start date: September 29, 2018
• Est. completion date: December 26, 2019

Study information

• Verified date: November 2021
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 26, 2019
• Est. primary completion date: December 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Peritoneal Dialysis

Intervention

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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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):4 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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.
Primary	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	all cause mortality	mortality due to all causes	30-day, 60-day, 90-day after the patient enrolls in the study.
Secondary	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.
Secondary	length of hospital stay	total days for hospital stay	90 days of the study since the patient enrolls in the study
Secondary	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.
Secondary	Incidence of dialysis transferring	Incidence of dialysis transferring from PD to HD	At 90 days after patient enrolls in the study
Secondary	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
Secondary	in-hospital cost	in-hospital cost, including expenses of examinations, treatments and manpower cost.	At 90 days after patient enrolls in the study