Contact information
Type
Scientific
Primary contact
Ms Jungmin Im
ORCID ID
Contact details
4F 145-9 KLC B/D
Samseong-dong
Kangnam-gu
Seoul
135-090
Korea
South
+82 (0)22 240 0560
jungmin.im@gambro.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Hemo01_042011
Study information
Scientific title
Clinical evaluation of Hemocontrol in hypotension-prone hemodialysis patients: a multicenter prospective cross-over study
Acronym
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.
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
Study design
Prospective open-label study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request patient information sheet
Condition
Chronic Kidney Disease
Intervention
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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 measures
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)
Overall trial start date
18/07/2011
Overall trial end date
15/11/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
71
Participant 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
Recruitment start date
18/07/2011
Recruitment end date
15/11/2011
Locations
Countries of recruitment
Korea, South
Trial participating centre
4F 145-9 KLC B/D
Seoul
135-090
Korea, South
Sponsor information
Organisation
Gambro Korea Ltd. (Korea, South)
Sponsor details
4F KLC B/D
Samseong-dong
Kangnam-gu
Seoul
135-090
Korea
South
+82 (0)22 240 0560
jungmin.im@gambro.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Gambro Korea Ltd. (Korea, South) (Reference No.: Hemo01_042011)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary