Chronic Kidney DiseaseNCT02881892
Iplasma IL6, Procalcitonin and VEGF and Dialysate Level in CAPD Patients
An observational study of Chronic Kidney Disease, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Measure plasma and dialysate level of IL-6, procalcitonin and VEGF
- How many people
- 26 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2012to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CAPD patients age more than 18 years
Who may be able to join
- Stable CAPD patients without previous history of peritonitis
Who cannot join
- HIV
- Other infections, tuberculosis or on immunosuppressive drugs,
- Autoimmune disease,
- Cancer
- Diagnosis of permanent ultrafiltration failure .
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Renal Unit, BMA Medical College and Vajira Hospital
Bangkok, 10300
About this study
Official title: Interleukin-6, Procalcitonin and Vascular Endothelial Growth Factor in Plasma and Dialysate Correlate With Peritoneal Solute Transport and Dialysis Adequacy in CAPD Patients
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.
Read the detailed 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Measure plasma and dialysate level of IL-6, procalcitonin and VEGF
- Keywords
- CAPD, Peritoneal solute transport rate, Dialysis adequacy
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma level of VEGF, IL-6 and procalcitonin with the PSTR and dialysis adequacy in CAPD patients
measure in pg/ml
Measured: 2 years
Secondary outcomes (1)
Cytokines in diabetic and non-diabetic group
All cytokines in plasma and blood
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startMar 2012
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital
- Investigators
- Thananda Trakarnvniach, M.D., Principal investigator, Department of Medicine,Vajira Hospital,Navamindradhiraj University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881892
- Sponsor's protocol ID
- 041/57
- Status last verified
- Aug 2016
- First submitted
- 18 Aug 2016
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 20061317Alscher 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.
PubMed 16178476Herget-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.
PubMed 15683455Guz 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.
PubMed 16623432Pecoits-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.
PubMed 12147798
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interleukin-6, Procalcitonin and Vascular Endothelial Growth Factor in Plasma and Dialysate Correlate With Peritoneal Solute Transport and Dialysis Adequacy in CAPD Patients
- ClinicalTrials.gov ID
- NCT02881892
- Acronym / sponsor ID
- 041/57
- Conditions
- Chronic Kidney Disease
- Keywords
- CAPD, Peritoneal solute transport rate, Dialysis adequacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira HospitalOther government
- Study start
- Mar 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CAPD patients age more than 18 years
Key inclusion criteria (1 listed)
- Stable CAPD patients without previous history of peritonitis
Key exclusion criteria (5 listed)
- HIV
- Other infections, tuberculosis or on immunosuppressive drugs,
- Autoimmune disease,
- Cancer
- Diagnosis of permanent ultrafiltration failure .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measure plasma and dialysate level of IL-6, procalcitonin and VEGFcorrelation between plasma levels, dialysate appearance rate of VEGF, inflammatory cytokines (IL- 6, procalcitonin) and PSTR, dialysis adequacy in CAPD patients. | Other | – |
Primary outcome
plasma level of VEGF, IL-6 and procalcitonin with the PSTR and dialysis adequacy in CAPD patients
Time frame: 2 years
measure in pg/ml
1 secondary outcome
Cytokines in diabetic and non-diabetic group
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
- Background: PubMed 20061317Oh 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.
- Background: PubMed 16178476Alscher 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.
- Background: PubMed 15683455Herget-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.
- Background: PubMed 16623432Guz 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.
- Results publication: PubMed 12147798Pecoits-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thananda Trakarnvniach, M.D. principal investigator
Department of Medicine,Vajira Hospital,Navamindradhiraj University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma level of VEGF, IL-6 and procalcitonin with the PSTR and dialysis adequacy in CAPD patients (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02881892, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2016.