The objective of the study is to develop a non-invasive method to detect the early signs of oncoming hypotension during haemodialysis in order to prevent these from occurring
ID
Source
Brief title
Condition
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study parameters are ISTI, delta-ISTI (respiratory variation in ISTI),
RR-interval, delta-RR (respiratory variation in RR-interval), ISTI/RR,
delta-ISTI/RR (respiratory variation in ISTI) systolic, diastolic and mean
bloodpressure, haematocrit value and calf impedance. Also the occurrence of
hypotensive periods will be recorded.
Secondary outcome
Relative blood volume (RBV), total bodywater, extracellular water and calf
extracellular resistance in order to compare parameters derived from ISTI with
more traditional markers of haemodynamic status during haemodialyis . These
markers will be combined in order to establish the most predictive model for
the occurrence of intradialytic hypotension. Also descriptive and
anthropometric data will be collected.
Background summary
In the treatment of kidney failure by haemodialysis the normal function of the
kidneys is replaced by intermittent dialysis sessions. Although this artificial
process mimics the physiological process by the kidneys, the intermittent
character of the treatment creates unphysiological differences in
concentrations and in fluid shifts across the compartments. As a consequence,
sudden drops in blood pressure may occur during the dialysis sessions. A
diagnostic method that predicts the occurrence of these drops in blood pressure
will facilitate measures for the prevention of this occurrence and will
therefore serve the well-being of the patients and the adequacy and efficiency
of the treatment.
Study objective
The objective of the study is to develop a non-invasive method to detect the
early signs of oncoming hypotension during haemodialysis in order to prevent
these from occurring
Study design
The study concerns the evaluation of a method of measurement by comparison with
other methods and with the occurrence of hypotensive periods. Fourty-five
patients who are treated at the haemodialysis unit of the VU University
medical center will be measured twice during standard dialysis treatments in
order to establish the reproducibility of the observations. The course of the
initial systolic time interval (ISTI) and the respiratory change (delta-ISTI)
will be recorded throughout the dialysis session These measures will be
compared with standard clinical parameters: the simultaneous non-invasively
recorded haematocrit value and manual blood pressure readings every 15 minutes,
and with calf-impedance and hydration status before haemodialysis.
Study burden and risks
An additional number of four electrodes, similar to ECG-electrodes, will be
attached to the patient in order to measure the ISTI parameters. (In another
measurement unit an additional number of two electrodes are applied to measure
the ECG separately from the other electrodes). A small electrical current of
0.3 mA rms will be transmitted through the thorax applied by the two outer
electrodes, having a frequency of 64 kHz. The frequency of this current is well
above the range of biological excitation and the amplitude is well below the
range of biological excitation or sensing. The method is safe to be used on the
haemodialysis unit. The method is non-invasive. Participating in the study
contains no burden and no risk for the subjects. The nature or duration of the
dialysis treatment will not change.
For comparison with the ISTI parameters, extracellular water and total body
water are measured before haemodialysis via four electrodes placed on the wrist
and ankle, using the commercially available Body Composition Monitor (BCM,
Fresenius Medical Care). Also for comparison with the ISTI parameters, calf
extracellular resistance is continuously measured throughout the haemodialysis
session using four electrodes, placed on the lateral aspect of the calf. Also
this equipment is commercially available (Hydra 4200, Xitron Technologies, San
Diego, CA, USA). Also these measurements contain no burden and no risk for the
subjects. The nature or duration of the dialysis treatment will not change. The
BCM-measurement before haemodialysis will take only a couple of minutes.
de Boelelaan 1117
Amsterdam 1081 HV
NL
de Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
All patients who are treated with chronic intermittent haemodialysis at the dialysis unit of the VU University medical center.
Exclusion criteria
Younger than 18 years of age; medical, ethical and practical drawbacks or objections to participate. Patients with a pacemaker or implantable cardioverter-defibrillator (ICD) will be excluded.
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 | NL41201.029.12 |