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Patients recruited difficult.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Intervention group is intensive dosage of PD. |
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| Control group | Active Comparator | Control group is regular dosage of PD. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive dosage of PD | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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 |
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| all cause mortality | mortality due to all causes | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jie Dong, PhD | Peking Universiy First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renal Division and Institute of Nephrology, Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25074995 | Result | 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. |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Regular dosage of PD | Procedure | 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. |
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| 30-day, 60-day, 90-day after the patient enrolls in the study. |
| length of hospital stay | total days for hospital stay | 90 days of the study since the patient enrolls in the study |
| 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. |
| Incidence of dialysis transferring | Incidence of dialysis transferring from PD to HD | 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 | At 90 days after patient enrolls in the study |
| in-hospital cost | in-hospital cost, including expenses of examinations, treatments and manpower cost. | At 90 days after patient enrolls in the study |
| Cangzhou central hospital |
| Cangzhou |
| Hebei |
| China |
| Nanyang City Center Hospital | Nanyang | Henan | China |
| Pingdingshan People's Hospital No.1 | Pingdingshan | Henan | China |
| 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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |