NL-OMON55297
Completed
Phase 3
The evaluation of the influence of the use of total blood volume measurement during dialysis on the incidence of intradialytic hypotension associated events - Total blood volume measurement in hemodialysis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- HagaZiekenhuis
- Enrollment
- 59
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •hemodialysis patients of three dialysis locations of the Haga Hospital
- •(Zoetermeer, The Hague Leyweg and The Hague Sportlaan).
- •\- Chronic hemodialysis patients in whom initiation of treatment predates
- •inclusion in the study by \>\= 3 months.
- •\- Hemodialysis scheme three times weekly for four hours (Monday \- Wednesday \-
- •Friday or Tuesday \- Thursday \- Saturday)
- •\- Age \>18 years.
- •\- Signed informed consent must be obtained prior to any study specific
- •procedures.
Exclusion Criteria
- •Clinically relevant fistula dysfunction resulting in spKtV \<1,2
- •Severe volume overload with a contraindication to bolus fluid infusion during
- •dialysis according to the treating physician.
- •Severe cardiac dysfunction responsible for \>1x intradialytic hypotension
- •associated adverse event /week according to treating physician
- •Severe liver failure with or without presence of ascites
- •More than three hemodialysis sessions per week
- •Single needle treatment
- •Central venous access
- •Residual diuresis
Outcomes
Primary Outcomes
Not specified
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