Clinical evaluation of Hemocontrol in hypotension-prone hemodialysis patients

Clinical evaluation of Hemocontrol in hypotension-prone hemodialysis patients: a multicenter prospective cross-over study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN96130697

Enrollment

Registered

2011-11-21

Start date

2011-07-18

Completion date

Unknown

Last updated

2017-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease Urological and Genital Diseases Glomerular diseases

Interventions

Comparing A) current best practice HD (baseline) with B) Hemocontrol HD, in an AB cross-over design. Study period A (baseline): Current best practice HD ? 8 weeks evaluation 1. Regular treatment setu

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Incidence rate of dialysis treatments affected by one or more symptomatic hypotensive episodes, comparing Hemocontrol HD to current best practice HD 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

Measure	Time frame
1. Pre- and post-dialysis systolic and diastolic blood pressure (alternatively mean arterial blood pressure) 2. Post-dialysis body weight (dry weight) 3. Inter-dialytic weight gain 4. Symptoms during dialysis that appear without hypotension: muscular cramps, dizziness, nausea 5. Patients? subjective assessment of tiredness after dialysis 6. Dialysis dose delivered ? Urea Reduction Ratio (URR) 7. Blood biochemistry data for sodium, calcium, phosphorus, potassium, hemoglobin, and albumin 8. 48hrs blood pressure (BP) monitoring (describe BP medications during monitoring)	—

Measure

Time frame

1. Pre- and post-dialysis systolic and diastolic blood pressure (alternatively mean arterial blood pressure) 2. Post-dialysis body weight (dry weight) 3. Inter-dialytic weight gain 4. Symptoms during dialysis that appear without hypotension: muscular cramps, dizziness, nausea 5. Patients? subjective assessment of tiredness after dialysis 6. Dialysis dose delivered ? Urea Reduction Ratio (URR) 7. Blood biochemistry data for sodium, calcium, phosphorus, potassium, hemoglobin, and albumin 8. 48hrs blood pressure (BP) monitoring (describe BP medications during monitoring)

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Countries

Korea, South

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026