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Urgent-start Peritoneal Dialysis in ESRD Patients:Safety and Efficacy

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ClinicalTrials.gov Identifier: NCT02946528
Recruitment Status : Not yet recruiting
First Posted : October 27, 2016
Last Update Posted : October 27, 2016
Sponsor:
Collaborators:
Changhai Hospital
Longhua Hospital
Shanghai Songjiang District Central Hospital
Information provided by (Responsible Party):
RenJi Hospital

Brief Summary:
Within the last decade, urgent-start peritoneal dialysis(PD) has gained considerable interest amongst nephrologists. Several publications have provided assurances that urgent-start PD is indeed feasible and can serve patients well; however, most of the studies have small sample sizes, retrospective design, and the impact of the urgent-start dialysis modality on outcome, especially on short-term complications, has not been directly evaluated. Therefore, we started this multi-centered, prospective, interventional study compared the dialysis-related complications and survival rate directly between urgent-start PD and HD groups with a large sample to determine the feasibility and safety of urgent-start PD as an alternate initial modality of dialysis for patients who require urgent initiation of dialysis therapy.

Condition or disease Intervention/treatment Phase
End-Stage Renal Disease Device: urgent-start peritoneal dialysis catheter Device: central venous catheter Not Applicable

Detailed Description:
The prevalence of chronic kidney disease (CKD) and end-stage renal disease (ESRD) is on the rise worldwide. Moreover, many patients who progress to ESRD, even with regular nephrology follow-up, do not have a distinct plan at the time of initiating dialysis therapy, resulting in an urgent need for dialysis. Urgent-start dialysis refers to urgent initiation of dialysis for ESRD patients with no pre-established functional vascular access or peritoneal dialysis (PD) catheter. Hemodialysis (HD) is preferred in most centers with a high rate of central venous catheter (CVC) use at the time of initiating dialysis among HD patients. There is a significantly increased risk of infectious complications, thrombosis, and other complications associated with CVC use which negatively affects patient prognosis. Within the last decade, urgent-start PD has gained considerable interest amongst nephrologists. Several publications have provided assurances that urgent-start PD is indeed feasible and can serve patients well; however, most of the studies have small sample sizes, and the impact of the urgent-start dialysis modality on outcome, especially on short-term complications, has not been directly evaluated. Therefore, we conducted this multicenter, prospective, randomized clinical trial to compare the dialysis-related complications and survival rate directly between urgent-start PD and HD groups with a large sample to determine the feasibility and safety of urgent-start PD as an alternate initial modality of dialysis for patients who require urgent initiation of dialysis therapy.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center Clinical Tial of Safety and Efficacy of Urgent-start Peritoneal Dialysis in ESRD Patients
Study Start Date : October 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Arm Intervention/treatment
Experimental: urgent-start peritoneal dialysis
All patients in urgent-start peritoneal dialysis arm initiate peritoneal dialysis as urgent-start dialysis modality.
Device: urgent-start peritoneal dialysis catheter
Patients initiated peritoneal dialysis as urgent-start dialysis modality with a peritoneal dialysis catheter.

Active Comparator: urgent-start hemodialysis
All patients in urgent-start hemodialysis arm initiate hemodialysis as urgent-start dialysis modality.
Device: central venous catheter
Patients initiated hemodialysis as urgent-start dialysis modality with a central venous catheter.




Primary Outcome Measures :
  1. number of participants with dialysis-related complications [ Time Frame: 12 months ]
    number of participants with dialysis-related complications including infectious complications(peritonitis and catheter-related infection) and noninfectious complications(thrombosis, bleeding, malposition and blockage)


Secondary Outcome Measures :
  1. number of participants with cardiac vascular diseases [ Time Frame: 12 months ]
    number of participants with cardiac vascular diseases (including angina, myocardial infarction, severe heartfailure and arrhythmia)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ESRD patients who need urgent-start dialysis(Urgent-start dialysis is defined as ESRD patients who required initiation of dialysis in 2 weeks without pre-established functional vascular access or a PD catheter.)
  • patients who signs a informed consent form

Exclusion Criteria:

  • patients with severe pulmonary edema
  • patients with severe respiratory insufficiency
  • patients with severe hypertension(diastolic blood pressure >120mmHg)
  • patients with hyperkalemia (>6.5 mmol/L)
  • patients with a history of abdominal operation within 6 months
  • patients with abdominal skin cellulitis,celiac-pleural leakage and peritonitis
  • patients with malignancy
  • patients with mental disorder
  • patients with pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946528


Contacts
Contact: Zhaohui Ni, Doctor +8613917735313 profnizh@126.com
Contact: Shan Mou, Doctor +8613918221242 shan_mou@126.com

Sponsors and Collaborators
RenJi Hospital
Changhai Hospital
Longhua Hospital
Shanghai Songjiang District Central Hospital
Investigators
Study Chair: Zhaohui Ni, Doctor Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Study Director: Shan Mou, Doctor Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Principal Investigator: Zhiyong Guo, Doctor Changhai Hospital
Principal Investigator: Yueyi Deng, Doctor Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Principal Investigator: Xiujuan Zang, Doctor Shanghai Songjiang District Central Hospital
Principal Investigator: Biyun Qian, Doctor School of Medicine,Shanghai Jiao Tong University
Principal Investigator: Qin Wang, Doctor Renji Hospital,School of Medicine,Shanghai Jiao Tong University
Principal Investigator: Haijiao Jin, Doctor Renji Hospital,School of Medicine,Shanghai Jiao Tong University

Publications:

Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT02946528     History of Changes
Other Study ID Numbers: RJ20161021USPD
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases