Peritoneal DialysisNCT03438877
Intensive Versus Regular Dosage For PD In AKI.
A study testing Intensive dosage of PD and Regular dosage of PD in people with Peritoneal Dialysis and Acute Kidney Injury, run by Peking University First Hospital at 7 sites in China.
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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Peritoneal Dialysis, Acute Kidney Injury
- What is being tested?
- Intensive dosage of PD and Regular dosage of PD
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 7 sitesChina
- Study dates
- 29 Sep 2018to 26 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age older than 14 years;
- Be diagnosed as AKI according to KDIGO recommendation;
- Having indications for renal replacement therapy.
Who cannot join
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Renal Division and Institute of Nephrology, Peking University First Hospital
Beijing, Beijing Municipality, 100034
Cangzhou central hospital
Cangzhou, Hebei
The People's Hospital of Chuxiong Yi Autonomous Prefecture
Chuxiong, Yunnan
Minda Hospital of Hubei Minzu University
Enshi, Hubei
Nanyang City Center Hospital
Nanyang, Henan
Pingdingshan People's Hospital No.1
Pingdingshan, Henan
Yichang Central People's Hospital
Yichang, Hubei
About this study
Official title: Intensive Versus Regular Dosage For Peritoneal Dialysis In Non-Hypercatabolic Acute Kidney Injury, A Multicenter Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Peritoneal Dialysis, Acute Kidney Injury
- Being tested
- Intensive dosage of PD, Regular dosage of PD
- Keywords
- acute kidney injury, peritoneal dialysis, dosage
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive dosage of PDProcedure or surgery
Also called intensive 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 PDProcedure or surgery
Also called regular 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group is intensive dosage of PD. Receives: Procedure: Intensive dosage of PD |
| Control group | Active comparator | Control group is regular dosage of PD. Receives: Procedure: Regular dosage of PD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate of the trial
Recruitment rate of patients screened for the trial measured by percentage.
Measured: 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.
Measured: 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.
Measured: 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
Measured: From date of randomization until 90 days after the randomization of last participant.
Secondary outcomes (7)
all cause mortality
mortality due to all causes
Measured: 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.
Measured: 30-day, 60-day, 90-day after the patient enrolls in the study.
length of hospital stay
total days for hospital stay
Measured: 90 days of the study since the patient enrolls in the study
Days for dialysis treatment
Days for dialysis treatment, including PD and HD
Measured: 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
Measured: 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
Measured: At 90 days after patient enrolls in the study
in-hospital cost
in-hospital cost, including expenses of examinations, treatments and manpower cost.
Measured: At 90 days after patient enrolls in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start29 Sep 2018
- Primary completion26 Dec 2019
- Study completion26 Dec 2019
Why it stopped: Patients recruited difficult.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Jie, Peking University First Hospital
- Investigators
- Jie Dong, PhD, Principal investigator, Peking Universiy First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438877
- Sponsor's protocol ID
- PDDOSE study
- Status last verified
- Nov 2021
- First submitted
- 8 Feb 2018
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25074995
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Versus Regular Dosage For Peritoneal Dialysis In Non-Hypercatabolic Acute Kidney Injury, A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03438877
- Acronym / sponsor ID
- PDDOSE study
- Conditions
- Peritoneal Dialysis, Acute Kidney Injury
- Keywords
- acute kidney injury, peritoneal dialysis, dosage
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patients recruited difficult.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 29 Sep 2018 (actual)
- Primary completion
- 26 Dec 2019 (actual)
- Study completion
- 26 Dec 2019 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Intensive dosage of PDIntervention group is intensive dosage of PD. |
| Control group | Active comparator | Procedure: Regular dosage of PDControl group is regular dosage of PD. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age older than 14 years;
- Be diagnosed as AKI according to KDIGO recommendation;
- Having indications for renal replacement therapy.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive dosage of PDAlso: intensive PDWithin 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. | Procedure or surgery | Intervention group |
| Regular dosage of PDAlso: regular PDWithin 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. | Procedure or surgery | Control group |
Primary outcome
Recruitment rate of the trial
Time frame: 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
Time frame: From date of randomization until 90 days after the randomization of last participant
Retention rate of included patients in the trial measured by percentage.
Adherence rate of the trial
Time frame: From date of randomization until 90 days after the randomization of last participant.
Percentage of participants adherent to the dosing regimen of PDDOSE study.
Incidence of adverse events
Time frame: 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
7 secondary outcomes
all cause mortality
Time frame: 30-day, 60-day, 90-day after the patient enrolls in the study.
The rate of renal recovery
Time frame: 30-day, 60-day, 90-day after the patient enrolls in the study.
length of hospital stay
Time frame: 90 days of the study since the patient enrolls in the study
Days for dialysis treatment
Time frame: From date when a patient begins peritoneal dialysis until the date of dialysis withdrawal, assessed up to 90 days.
Incidence of dialysis transferring
Time frame: At 90 days after patient enrolls in the study
Incidence of comorbidities
Time frame: At 90 days after patient enrolls in the study
in-hospital cost
Time frame: At 90 days after patient enrolls in the study
Results and safety
The study was stopped early (reason given: Patients recruited difficult.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Results publication: PubMed 25074995Cullis 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.
- Individual participant dataSharing planned: No
Related trials for Peritoneal Dialysis
Not yet recruiting
Iodine Starch Test Use in Pleuroperitoneal Leak
Peritoneal Dialysis, Peritoneal Dialysis (PD)
RecruitingPhase 2
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
End Stage Renal Disease on Dialysis, Peritoneal Dialysis Complication
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
RecruitingObservational study
Continuous Glucose Monitoring in Patients With Diabetes on Peritoneal Dialysis
Kidney Disease, Chronic, Peritoneal Dialysis
Not yet recruiting
Acupuncture for Symptom Burden and Quality of Life in Patients With End-Stage Kidney Disease
End Stage Kidney Disease (ESKD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Dong, PhD principal investigator
Peking Universiy First Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive dosage of PD and Regular dosage of PD in people with Peritoneal Dialysis and Acute Kidney Injury, run by Peking University First Hospital at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Patients recruited difficult.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate of the trial (time frame: From date of randomization until the randomization of last participant.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03438877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.