The evaluation of the influence of the use of total blood volume measurement during dialysis on the incidence of intradialytic hypotension associated events
- Conditions
- dry weighttarget weight in hemodialysis10038430
- Registration Number
- NL-OMON55297
- Lead Sponsor
- HagaZiekenhuis
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 59
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.
• 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
• Inability to provide informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to investigate the effectivity of total blood volume<br /><br>measurement and the identification of a critical threshold to predict and<br /><br>prevent intra-dialytic hypotension and/or associated symptoms (IHAAE).It will<br /><br>be investigated wheter adjustment of target weight, based on the critical<br /><br>threshold of total blood volume, results in a decline of IHAAE frequency.IHAAE<br /><br>is defined as a systolic blood pressure < 90 mmHg eiter symptomatic or<br /><br>asymptomatic, or solely symptoms associated to (impeding) hypotension like<br /><br>dizziness, lightheadedness, sweating, cramps or visuel disturbances.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. To investigate the incidence of asymptomatic hypotension in the intervention<br /><br>group compared the control group.<br /><br>2. To investigate the incidence hypotension-associated symptoms without<br /><br>hypotension in the intervention group compared to the control group.<br /><br>3. To explore the distribution of normalized total blood volume and relative<br /><br>blood volume in stable subjects and subjects with IHAAE.<br /><br>4. To calculate the sensitivity, specificity, positive predictive value and<br /><br>negative predictive value of the previously defined critical threshold for the<br /><br>normalized total blood volume of 65 ml/kg and the receiver operator<br /><br>characteristics for this threshold.<br /><br>5. To compare measured total blood volume with calculated blood volume using<br /><br>Nadler*s formula</p><br>