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Noninferiority Randomized, Multi-center, Open-label Controlled Trial Comparing Peritonitis Rate between One Cuffed Versus Two Cuffed Peritoneal Dialysis Catheter Insertion in patients with Acute Kidney Injury Requiring Acute Peritoneal Dialysis treatment

Noninferiority Randomized,Multi-center,Open-label Controlled Trial Comparing Peritonitis Rate between One Versus Two-Cuffed Peritoneal Dialysis Catheter Insertion in patients with Acute Kidney Injury Requiring Acute Peritoneal Dialysis treatment

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200421003
Enrollment
160
Registered
2020-04-21
Start date
2020-03-18
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute kidney injury requiring acute peritoneal dialysis treatment. acute kidney injury peritoneal dialysis catheter one cuff technique peritonitis acute peritoneal dialysis

Interventions

The internal cuff placed in/on the rectus muscle. The external cuff is left outside the body. ,The internal cuff is placed in/on the rectus muscle. The external cuff is buried in the subcutaneous laye
Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery
one cuff,Two cuff

Sponsors

awaiting approval from Thai Kidney foundation
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with acute kidney injury (KDIGO staging) requiring acute peritoneal dialysis treatment 2. Age >18 3. No contraindications for peritoneal dialysis treatment 4. Body weight below 100 kilograms 5. Participant is willing and able to give informed consent for participation in the study

Exclusion criteria

Exclusion criteria: 1. Patient with severe hypercatabolic stage or expect to pass away within 24 hours 2. Patients with known underlying advanced chronic kidney disease stage 5 (per KDIGO guideline) prior to hospital admission 3. Patients with recent abdominal surgery withing 3 months prior to hospital admission 4. Patients with chronic skin infection or disorders 5. Patient who has kidney transplantation 6. Patients with midline surgical scar 7. Patients with intr-aabdominal infection 8. Patients with human immunodeficiency virus (HIV) infection 9. Patients who denies to participate, unable to give informed consent, or withdraw from the current study

Design outcomes

Primary

MeasureTime frame
peritonitis rate from randomization to the end of treatment peritonitis rate during acute peritoneal dialysis treatment

Secondary

MeasureTime frame
Mechanical complication from randomization to the end of treatment incidence of hernia,Mechanical complication from randomization to the end of treatment incidence of leak,exit site infection from randomization to the end of treatment incidence of exit site infection,Technique survival from randomization to the end of treatment time before catheter removal; excluding recovery of renal function,30-day mortality rate 30 day after randomization percent,microbiological pattern of acute PD peritonitis from randomization to the end of treatment microbiological pattern,peritonitis free day from randomization to event day

Countries

Thailand

Contacts

Public ContactSarinya Boongird

Ramathibodi Hosptial

sarinya.bon@mahidol.ac.th022011400

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026