NCT02881892

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
Last Updated

August 29, 2016

Status Verified

August 1, 2016

Enrollment Period

2.2 years

First QC Date

August 18, 2016

Last Update Submit

August 26, 2016

Conditions

Chronic Kidney Disease

Keywords

CAPDPeritoneal solute transport rateDialysis adequacy

Outcome Measures

Primary Outcomes (1)

  • plasma level of VEGF, IL-6 and procalcitonin with the PSTR and dialysis adequacy in CAPD patients

    measure in pg/ml

    2 years

Secondary Outcomes (1)

  • Cytokines in diabetic and non-diabetic group

    2 years

Interventions

Measure plasma and dialysate level of IL-6, procalcitonin and VEGFOTHER

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CAPD patients age more than 18 years

You may qualify if:

  • Stable CAPD patients without previous history of peritonitis

You may not qualify if:

  • HIV
  • Other infections, tuberculosis or on immunosuppressive drugs,
  • Autoimmune disease,
  • Cancer
  • Diagnosis of permanent ultrafiltration failure .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renal Unit, BMA Medical College and Vajira Hospital

Bangkok, 10300, Thailand

Location

Related Publications (5)

  • 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.

    PMID: 20061317BACKGROUND

  • Alscher DM, Mettang T. Procalcitonin in peritoneal dialysis--a useful marker of inflammation? Perit Dial Int. 2005 Sep-Oct;25(5):441-4. No abstract available.

    PMID: 16178476BACKGROUND

  • 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. doi: 10.1111/j.0300-9475.2005.01545.x.

    PMID: 15683455BACKGROUND

  • 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.

    PMID: 16623432BACKGROUND

  • Pecoits-Filho R, Araujo MR, Lindholm B, Stenvinkel P, Abensur H, Romao 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. 2002 Aug;17(8):1480-6. doi: 10.1093/ndt/17.8.1480.

    PMID: 12147798RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

ProcalcitoninVascular Endothelial Growth Factor A

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CalcitoninPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsProtein PrecursorsProteinsVascular Endothelial Growth FactorsAngiogenic ProteinsIntercellular Signaling Peptides and ProteinsBiological Factors

Study Officials

  • Thananda Trakarnvniach, M.D.

    Department of Medicine,Vajira Hospital,Navamindradhiraj University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 18, 2016

First Posted

August 29, 2016

Study Start

March 1, 2012

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

August 29, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)