To determine the general usefulness of and a proper moment when blood should be taken for the in vitro IFN-γ assays in patients undergoing chronic haemodialysis.
ID
Source
Brief title
Condition
- Ancillary infectious topics
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To identify the possible differences (intrapersonal variability) in the
proliferative function of:
- T-lymphocytes generally (using the phytohemaglutinine tube)
- TB-specific lymphocytes (using the Quantiferon-GIT test)
- CMV-specific lymphocytes (using the Quantiferon-CMV test)
- HB-specific lymphocytes (using the Quantiferon-HB)
between the blood samples which were drawn before, during and after the same
hemodialysis.
Secondary outcome
1. differences in the proportion of patients with indeterminate test result in
the positive controle tube (phytohaemaglutinine) in the haemodialysis, PD,
non-haemodialysis renal failure and control groups
2. differences in the proportion of patients with positive Quantiferon-CMV test
in the hemodialysis, PD, non-HD renal failure and control groups
3. differences in the proportion of patients with positive Quantiferon-HB test
in the hemodialysis, PD, non-HD renal failure and control groups
4. differences in the proliferative capacity measured as the amount of produced
IFN-γ in the positive controle tube between the group of patients with
hemodialysis, PD, non-HD renal failure and control group
Background summary
In vitro interferon-gamma (IFN-γ) assays are able to quantitatively measure
the IFN-γ production by the sensitized T-lymphocytes (CD4 of CD8-positive) as
response to the specific antigen(s) they previously have been sensitized with
(as a result of natural infection or vaccination). Various antigens can be used
for the T-lymphocyte in vitro stimulation. The usefulness of the in vitro IFN-γ
assays has extensively been tested to diagnose latent tuberculosis. The
response to the other antigens such as cytomegalovirus (CMV) and hepatitis B
(HB) antigens can also be determined. To obtain the reliable results it is
necessary that the proliferatieve T-lymphocyte function is normal.
Haemodialysis patients are at increased risk for the infectious complications.
There are many clinical situations where in vitro IFN-γ assay could be implied
to determine the etiology of the infection, to start the pre-emptive therapy or
to assess the effectivity of the vaccination.
However, the important missing information is the influence of the hemodialysis
on the proliferative function of the T lymphocytes which could increase the
frequency of the indeterminate results if blood is not drawn at the proper
moment with regard to the dialysis session.
Study objective
To determine the general usefulness of and a proper moment when blood should be
taken for the in vitro IFN-γ assays in patients undergoing chronic
haemodialysis.
Study design
This study will be a cross-sectional study, with 4 groups of patients.
The following procedures will be performed:
I. Patients treated with haemodialysis (group A):
- intravenous blood will be collected before, 30 minutes after the start and at
the end of the same haemodialysis, 5 tubes will be filled at each time point,
each with 1 milliliter blood.
II. Patients treated with peritoneal dialysis, patients with renal
insufficiency but no renal replacement therapy and healthy controls (groups B,
C, D):
- intravenous blood will be collected once (cca 20 ml blood) between 8 and 12
a.m.
The five blood tubes will be used to perform the next tests:
- Quantiferon-GIT test tube (tuberculosis antigens),
- Quantiferon-CMV test tube (CMV antigens),
- Quantiferon-HB test tube (hepatitis B antigens),
- positive controle tube (phytohaemaglutinine as a mitogen),
- negative controle tube (no mitogen added).
After performing the QuantiFERON-GIT and Quantiferon-CMV and -HB tests the
tubes will be stored at -20o degrees Celsius for 5 years at the Laboratory of
Virology of the UMCU.
Study burden and risks
The burden associated with the participation is low (three venapunctures), the
risks of the participation are the same as the risk of the venapuncture
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
group A - renal failure, haemodialysis
group B - renal failure, peritoneal dialysis
group C - renal failure, no dialysis
Exclusion criteria
group D - renal failure and/or immunocompromising condition or immunosuppressive medication
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL18453.041.07 |