Clinical evaluation of Hemocontrol in hypotension-prone hemodialysis patients
Completed
- Conditions
- Chronic kidney diseaseUrological and Genital DiseasesGlomerular diseases
- Registration Number
- ISRCTN96130697
- Lead Sponsor
- Gambro Korea Ltd. (Korea, South)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 71
Inclusion Criteria
1. Hypotension-prone patients, i.e. patients showing symptomatic hypotensive episodes in response to fluid removal by dialysis in 25% or more of treatments during 1 month preceding the study
2. Mostly showing an inter-dialytic weight gain of 1.5 kg or more
3. Age between 18 and 75 years
4. On dialysis for at least 3 months, on three dialysis per week schedule
Exclusion Criteria
1. A regular pre-dialysis mean arterial blood pressure in supine position of <90 mmHg
2. Regular blood flow rate for dialysis lower than 200 ml/min
3. Ppre-dialysis hemoglobin level regularly above 13 g/dl
4. Treatment by hemodiafiltration (HDF)
5. Expected need for blood transfusions
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Incidence rate of dialysis treatments affected by one or more symptomatic hypotensive episodes, comparing Hemocontrol HD to current best practice HD <br>2. Hypotensive episodes defined as a decrease in systolic BP >=20 mmHg or a decrease in mean arterial pressure (MAP) by >=10 mmHg that is associated with characteristic symptoms and requires nurse intervention by any type
- Secondary Outcome Measures
Name Time Method 1. Pre- and post-dialysis systolic and diastolic blood pressure (alternatively mean arterial blood pressure)<br>2. Post-dialysis body weight (dry weight)<br>3. Inter-dialytic weight gain<br>4. Symptoms during dialysis that appear without hypotension: muscular cramps, dizziness, nausea<br>5. Patients? subjective assessment of tiredness after dialysis <br>6. Dialysis dose delivered ? Urea Reduction Ratio (URR) <br>7. Blood biochemistry data for sodium, calcium, phosphorus, potassium, hemoglobin, and albumin<br>8. 48hrs blood pressure (BP) monitoring (describe BP medications during monitoring)