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Completed

NCT Number: NCT01637792

Randomized Controlled Trial Comparing Residual Kidney Function in Patients Undergoing Three or Four Exchanges CAPD

The purpose of this study was to explore the impacts of different continuous ambulatory peritoneal dialysis (CAPD) dosage (three 2-Liter exchanges CAPD vs. four 2-Liter exchanges CAPD) on residual kidney function, technique survival, patient survival, and peritonitis in incident Chinese peritoneal dialysis patients.

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Key information

Conditions

End Stage Renal Disease Anuria Chronic Disease Digestive System Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Intraabdominal Infections Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Peritonitis Renal Insufficiency Renal Insufficiency, Chronic Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Renji Hospital, Shanghai Jiao Tong University school of medicine

Shanghai, Shanghai Municipality, 200127, China

About this study

  • The primary end point for this study was changes in residual kidney function including GFR, daily urine volume (Uvol), and anuria-free survival. GFR and Uvol were evaluated within 1 week before CAPD initiation (the baseline), and then at month 1, 6, 12, 18 and 24. At the same time, body weight, blood pressure, daily net ultrafiltration, dialysis adequacy, peritoneal solute transport rate, and biochemical parameters etc. were assessed. Once an episode of peritonitis or other serious reversible intercurrent illness occurred, all the assessments were delayed one month after being cured. Anuria was termed by daily Uvol permanently less than 100 ml.
  • The secondary end points included technique survival, patient survival and peritonitis. Technique failure was defined as switching to maintenance hemodialysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • incident CAPD patients aged 18 to 80 years
  • GFR ≥ 2 ml/min and Uvol ≥ 500 ml/day

Exclusion criteria

  • have a history of maintenance hemodialysis or renal transplantation
  • anticipated life expectancy less than 6 months
  • with active malignancy, acute infection, significant heart failure or in other severe conditions
  • unable to give informed consent

Treatment and study plan

Three 2-liter exchanges daily CAPD

Other

CAPD regimen of three 2-liter daily exchanges

Other names: small volume CAPD

Four 2-liter exchanges daily CAPD

Other

CAPD regimen of four 2-liter daily exchagnes

Other names: standard volume CAPD

Primary outcomes

  1. Residual kidney function including glomerular filtration rate (GFR), daily urine voume (Uvol), and anuria-free survival.

    Time frame: Up to 24 months after CAPD initiation

    GFR was calculated by the mean of renal clearance of urea and creatinine from a 24-h urine collection. Anuria was termed as consistently Uvol < 100 ml/day for more than a month.

Secondary outcomes

  1. Number of participants having technique failure refering to switching to maintenance hemodialyisis

    Time frame: Up to 24 months after CAPD initiation.

  2. Number of participants died

    Time frame: Up to 24 months after CAPD initiation

  3. Episodes of peritonitis

    Time frame: Up to 24 months after CAPD initiation

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Jul 11, 2012
Registry last updated
Jul 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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