Renal Insufficiency, Chronic
Conditions
Keywords
End-Stage Kidney Disease, Hypothermic hemodialysis, Cardiovascular events, Troponin T, Brain natriuretic peptide
Brief summary
Hemodialysis (HD) triggers recurrent and cumulative ischemic insults to the brain and the heart. Cooled dialysate may have a protective effect on major organs and improve hemodynamic tolerability of dialysis. The aim of the study was to compare HD with cooled dialysate with routine dialysis in terms of hemodynamic stability and levels of high sensitivity Troponin I (hs-TnI) and N-terminal pro b-type natriuretic peptide (NTproBNP) post dialysis
Interventions
PROCEDUREHypothermic dialysis followed with routine dialysis
Hypothermic dialysis (35.5 degrees Celsius dialysate) followed with routine dialysis (36.5 degrees Celsius dialysate)
PROCEDURERoutine dialysis followed with hypothermic dialysis
Routine dialysis (36.5 degrees Celsius dialysate) followed with hypothermic dialysis (35.5 degrees Celsius dialysate)
Sponsors
Ziv Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients with renal insufficiency treated with dialysis for a period of at least three months.
Exclusion criteria
* Patients who experienced myocardial infarction during the three months prior to the start of the study * Patients who underwent vascular surgery during the last month * Patients who experienced chest pain at rest during the last week before the start of the trial - Patients who had to discontinue dialysis prematurely due to hemodynamic instability.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of hypothermic dialysis with routine dialysis in terms of hemodynamic stability | one year | For each patient, four blood pressure measurements including systolic blood pressure, diastolic blood pressure and mean arterial pressure were performed at the beginning, after 2 hours, after 3 hours after 4 hours (end of hemodialysis). |
| Assessments of the levels of high sensitivite Troponin I (hs-TnI) and N-terminal pro b-type natriuretic peptide (NTproBNP) post dialysis | 6 months | Blood samples were collected at the beginning of the dialysis session, and a second sample was taken in the last 5 minutes of hemodialysis in order to evaluate the relationship between hemodialysis with cooled dialysate (hypothermic dialysis) and the myocardial markers hs-TnI and NTproBNP and to monitor hypothermic hemodiaysis treatment response. |
Countries
Israel
Outcome results
None listed