Condition category
Urological and Genital Diseases
Date applied
07/11/2011
Date assigned
21/11/2011
Last edited
06/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

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

http://www.gambro.com

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

Publication citations

Additional files

Editorial Notes