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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02881892
Other study ID # 041/57
Secondary ID
Status Completed
Phase N/A
First received August 18, 2016
Last updated August 26, 2016
Start date March 2012
Est. completion date June 2014

Study information

Verified date August 2016
Source Bangkok Metropolitan Administration Medical College and Vajira Hospital
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Observational

Clinical Trial Summary

The aim of study was to evaluated the correlation between plasma levels, dialysate appearance rate of VEGF, inflammatory cytokines (IL- 6, procalcitonin) and PSTR, dialysis adequacy in CAPD patients.


Description:

This cross -sectional study measured IL-6, procalcitonin and VEGF level in plasma and overnight effluent. PSTR of small solutes was evaluated by standard peritoneal equilibration test (standard PET). Weekly Kt/V and creatinine clearance (CCr ) were evaluated in all patients.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date June 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Stable CAPD patients without previous history of peritonitis

Exclusion Criteria:

- HIV

- Other infections, tuberculosis or on immunosuppressive drugs,

- Autoimmune disease,

- Cancer

- Diagnosis of permanent ultrafiltration failure .

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Intervention

Other:
Measure plasma and dialysate level of IL-6, procalcitonin and VEGF
correlation between plasma levels, dialysate appearance rate of VEGF, inflammatory cytokines (IL- 6, procalcitonin) and PSTR, dialysis adequacy in CAPD patients.

Locations

Country Name City State
Thailand Renal Unit, BMA Medical College and Vajira Hospital Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Bangkok Metropolitan Administration Medical College and Vajira Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

Alscher DM, Mettang T. Procalcitonin in peritoneal dialysis--a useful marker of inflammation? Perit Dial Int. 2005 Sep-Oct;25(5):441-4. — View Citation

Guz G, Colak B, Hizel K, Reis KA, Erten Y, Bali M, Sindel S. Procalcitonin and conventional markers of inflammation in peritoneal dialysis patients and peritonitis. Perit Dial Int. 2006 Mar-Apr;26(2):240-8. — View Citation

Herget-Rosenthal S, Klein T, Marggraf G, Hirsch T, Jakob HG, Philipp T, Kribben A. Modulation and source of procalcitonin in reduced renal function and renal replacement therapy. Scand J Immunol. 2005 Feb;61(2):180-6. — View Citation

Oh KH, Jung JY, Yoon MO, Song A, Lee H, Ro H, Hwang YH, Kim DK, Margetts P, Ahn C. Intra-peritoneal interleukin-6 system is a potent determinant of the baseline peritoneal solute transport in incident peritoneal dialysis patients. Nephrol Dial Transplant. 2010 May;25(5):1639-46. doi: 10.1093/ndt/gfp670. Epub 2010 Jan 8. — View Citation

Pecoits-Filho R, Araújo MR, Lindholm B, Stenvinkel P, Abensur H, Romão JE Jr, Marcondes M, De Oliveira AH, Noronha IL. Plasma and dialysate IL-6 and VEGF concentrations are associated with high peritoneal solute transport rate. Nephrol Dial Transplant. 20 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary plasma level of VEGF, IL-6 and procalcitonin with the PSTR and dialysis adequacy in CAPD patients measure in pg/ml 2 years Yes
Secondary Cytokines in diabetic and non-diabetic group All cytokines in plasma and blood 2 years Yes
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