Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06348589 |
| Other study ID # |
2023-05959-01 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 2024 |
| Est. completion date |
September 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Vrinnevi Hospital |
| Contact |
Magnus O Wijkman, MD, PhD |
| Phone |
00461040000 |
| Email |
magnus.wijkman[@]liu.se |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
High blood pressure is a risk factor for end-stage renal disease and is common in patients
undergoing maintenance hemodialysis. Intradialytic hypotension is associated with an adverse
prognosis. More knowledge is needed to identify patients at high risk for intradialytic
hypotension and dialysis-associated hypotensive episodes. The aim of this observational
single-center pilot study is to evaluate whether point-of-care ultrasound measurements may
predict intradialytic hypotension and orthostatic blood pressure falls, in patients with
chronic kidney disease who undergo maintenance hemodialysis.
Description:
Background: Hypertension is an independent risk factor for development of end-stage renal
disease and is the leading risk factor for cardiorenal death. It is estimated that more than
80% of patients with end-stage renal disease who undergo maintenance hemodialysis have
hypertension. Intensified blood pressure control has been associated with reduced risk of
death in patients with hypertension and chronic kidney disease but may increase the risk for
intra-dialytic blood pressure falls in patients who undergo hemodialysis.
Hemodialysis-associated hypotension has been associated with increased risks for
cardiovascular disease and mortality.
Aim: The aim of this observational pilot study is to evaluate whether point-of-care
ultrasound measurements may predict intradialytic hypotension and orthostatic blood pressure
falls, in patients with chronic kidney disease who undergo maintenance hemodialysis.
Ethics: The study has been approved by the Swedish Ethical Review Authority (2023-05959-01).
Study participants: All patients (n=70) with chronic kidney disease who undergo maintenance
hemodialysis at Vrinnevi Hospital in Norrköping, Sweden, will be invited to voluntarily
participate in the study. Information about the study will be given orally and in written
form. Those who opt to participate will be asked to sign a written informed consent.
Background data collection: For descriptive purposes, information will be collected regarding
current and prior medical diagnoses, current medical treatment, anthropometric data, and
self-perceived quality of lite (using the validated questionnaire KDQOL-SF). Blood samples
will be tested for routine hematological variables, as well as for sodium, potassium,
calcium, creatinine, urea and HbA1c.
Ultra-sound measurements: Before initiation of dialysis, point-of-care ultrasound
measurements will be performed with the patient resting in a supine position at a 30 degrees
angle, using a Sonosite SII ultrasound machine with a curvilinear probe. Measurements of the
diameter of the inferior vena cava will be performed at a level approximately 2 cm from the
right atrium, and breathing variability of its diameter will be assessed.
Blood pressure measurements: Systolic and diastolic blood pressure measurements will be
performed after the patient has been resting for 5 minutes in the supine position, with a
cuff size that is appropriate for each patient, with the arm resting at heart level, in the
arm where the patient does not have a dialysis fistula, using an automated blood pressure
measurement device (Fresenius 6008 CARE System) which is connected to the dialysis equipment.
Two measurements (with one minute apart) will be performed 30 minutes before the dialysis
session begins, three measurements will be performed after half of the planned dialysis
session, and two measurements will be performed 15 minutes after the dialysis session has
ended. An orthostatic test, which includes systolic and diastolic blood pressure measurements
taken immediately after standing up and 1 and 3 minutes after standing up, will also be
performed 30 minutes before the dialysis session begins and 15 minutes after the dialysis
session has ended.
Statistics: Background information (demographics, anthropometrics, medical history,
medication, biochemical evaluation) will be presented for the entire study population as
means with standard deviations, medians with inter-quartile ranges, or as counts with
percentages, as appropriate. These variables will also be presented in patients with and
without intradialytic blood pressure falls (defined as an intradialytic reduction of systolic
blood pressure ≥ 20 mmHg or of diastolic blood pressure ≥10 mmHg), and in patients with and
without orthostatic blood pressure falls (defined as an orthostatic reduction of systolic
blood pressure ≥ 20 mmHg or of diastolic blood pressure ≥10 mmHg), respectively.
Between-group differences will be tested for statistical significance using Student´s t-test,
Mann-Whitney U-test, Chi-square test or Fisher´s exact test, as appropriate.
Temporal changes in supine systolic and diastolic blood pressures (assessed prior to
dialysis, during dialysis and after dialysis) will be visualized with regression slopes, and
mixed models will be used to assess their associations with ultrasound measurements of the
inferior vena cava. Associations between ultrasound measurements of the inferior vena cava
and the blood pressure changes during the orthostatic blood pressure tests will be visualized
with scatter plots and tested for statistical significance with correlation analysis.
The predictive ability of ultrasound measurements of the inferior vena cava and the
occurrence of intra-dialytic blood pressure falls and of orthostatic blood pressure falls,
respectively, will be assessed with logistic regression.
