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Clinical evaluation of Hemocontrol in hypotension-prone hemodialysis patients
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| ISRCTN | ISRCTN96130697 |
| ClinicalTrials.gov identifier | |
| Public title |
Clinical evaluation of Hemocontrol in hypotension-prone hemodialysis patients
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| Scientific title | Clinical evaluation of Hemocontrol in hypotension-prone hemodialysis patients: a multicenter prospective cross-over study |
| Acronym | N/A |
| Serial number at source | Hemo01_042011 |
| Study hypothesis | Evaluate what effect an automatic blood volume controlled treatment approach (Hemocontrol) has on the incidence of intradialytic hypotension and other symptoms of dialysis, the change in blood pressure from pre to post dialysis, and the control of dry weight in Korean hypotension-prone hemodialysis (HD) patients. |
| Lay summary | Lay summary under review |
| Ethics approval |
Seoul St.Mary's Hospital approved on 07.08.2011, ref: CIRB-00039_23-01. All other centres will seek ethics approval before recruitment of the first participant
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| Study design | Prospective open-label study |
| Countries of recruitment | Korea, South |
| Disease/condition/study domain | Chronic Kidney Disease |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 18/07/2011 |
| Anticipated end date | 15/11/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request patient information sheet |
| Target number of participants | 71 |
| 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 setup 2. Regular clinical assessment of dry weight *Period A could be with any machine type (but it should be documented which machine) Study period B0: HD with Hemoscan blood volume monitoring – 2 weeks with Artis machine This is a preparation phase for the Hemocontrol period, required to establish the patients’ individual blood volume/ ultrafiltration (BV/UF) volume values that are required as input to Hemocontrol 1. Hemoscan function activated 2. Constant UF rate and constant dialysis fluid sodium setting throughout the HD treatment 3. Assessment of the blood volume (BV) curve shape 4. Assessment of the BV/UF vol parameter required by Hemocontrol Study period B1: Hemocontrol HD treatments – 8 weeks evaluation with Artis machine 1. Hemocontrol activated throughout the period 2. Hemocontrol BV/UF vol parameter initially set as determined in period B0 and thereafter adjusted in accordance with Hemocontrol guidelines (see appendix to be prepared) 3. Hemocontrol Equivalent sodium (Na) parameter set individually to the same value as used for dialysis fluid Na in the baseline period-Is there any reference about standard Serum Sodium level 4. Hemocontrol Max UF Coefficient and Na Limits parameters set at 1.5 and Standard, respectively 5. Dry weight initially set as in baseline period and thereafter adjusted based on clinical assessments and the information provided by the Hemocontrol refill indicators |
| Primary outcome measure(s) |
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 outcome measure(s) |
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) |
| Sources of funding | Gambro Korea Ltd. (Korea, South) (Reference No.: Hemo01_042011) |
| Trial website | |
| Publications | |
| Contact name | Ms Jungmin Im |
| Address |
4F 145-9 KLC B/D
Samseong-dong Kangnam-gu |
| City/town | Seoul |
| Zip/Postcode | 135-090 |
| Country | Korea, South |
| Tel | +82 (0)22 240 0560 |
| Fax | +82 (0)24 243 125 |
| jungmin.im@gambro.com | |
| Sponsor | Gambro Korea Ltd. (Korea, South) |
| Address |
4F KLC B/D
Samseong-dong Kangnam-gu |
| City/town | Seoul |
| Zip/Postcode | 135-090 |
| Country | Korea, South |
| Tel | +82 (0)22 240 0560 |
| Fax | +82 (0)24 243 125 |
| jungmin.im@gambro.com | |
| Sponsor website: | http://www.gambro.com |
| Date applied | 07/11/2011 |
| Last edited | 21/11/2011 |
| Date ISRCTN assigned | 21/11/2011 |
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| © 2012 ISRCTN unless otherwise stated. | |
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