Hypotension During DialysisNCT01492634
Optimizing Fluid Status
A study testing Prescription of post-dialytic weight based on BCM device in people with Hypotension During Dialysis, run by Francisco Maduell at 1 site in Spain.
Trial summary
Title of study: Optimizing Fluid Status Study code: HD-IIT-01-E Study design: Prospective open design in study centre at two locations Applied medical device: Body Composition Monitor (BCM) for determination of fluid overload and dry weight Aim of the study: To improve the fluid status in chronic HD patients (measured… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension During Dialysis
- What is being tested?
- Prescription of post-dialytic weight based on BCM device
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2011to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic renal failure stage V
- Treatment thrice weekly with HD or on-line HDF for at least 6 months prior to inclusion
- Ability to understand the nature and requirements of the study
- Age: at least 18 years
- Signed informed consent.
Who cannot join
- Interventional clinical study during the preceding 30 days or previous participation in the same study
- Acute or chronic infection (HIV, Hepatitis B or C, ...)
- Severe disease (malignant tumour, tuberculosis ...)
- Usually single needle HD
- Problems with shunt or high recirculation,
- Severe intra-dialytic blood pressure instability in the last month
- Instable angina pectoris
- Major amputation at arm or leg, or a pacemaker.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Investigation Plan Optimizing Fluid Status
Title of study: Optimizing Fluid Status
Study code: HD-IIT-01-E
Read more
Study design: Prospective open design in study centre at two locations
Applied medical device: Body Composition Monitor (BCM) for determination of fluid overload and dry weight
Aim of the study: To improve the fluid status in chronic HD patients (measured as OH (overhydration) or TAFO (time averaged fluid overload)) based on BCM measurements. Up to now, the BCM was occasionally applied in both locations of the study centre.
Study hypothesis: Regular measurement of fluid status (assessed by BCM) and display of dry weight (post-weight plan)will have significant consequences, namely a decrease of the:
- time averaged fluid overload (TAFO),
- proportion of patients with severe overhydration OH > 2.5 L,or OH/ECW > 15 %)
- proportion of dehydrated patients (OH < -1.0 L, or OH < -7 %),
- mean overhydration,
- variance of overhydration,
- time outside the reference range (-1.0L < OH < 2.5L).
Devices used in this study: Dialysis machine 5008 equipped with Blood Pressure Monitor BPM, Blood Volume Monitor BVM, Blood Temperature Monitor BTM, and Online Clearance Monitor OCM ; Body Composition Monitor BCM ; Data management software / database system NephroLink Disposables used in this study: BVM blood lines and BCM electrodes
Patients: 60 patients
- Conditions
- Hypotension During Dialysis
- Being tested
- Prescription of post-dialytic weight based on BCM device
- Keywords
- bioimpedance, overhydration, dry weight
- Medical subject headings
- Water Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescription of post-dialytic weight based on BCM deviceOther
Also called BCM or Body Composition Monitor Fresenius Medical Care
Prescription of post-dialytic weight target: On a weekly base, the patients are pre-dialytically measured by BCM (body composition monitor).
The time average fluid overload (TAFO) determines the target range. TAFO is defined as the mean value of pre- and post-dialytic overhydration (TAFO = (OHpre+OHpost)/2). The target range is set asymmetrically around a TAFO of 0.8, from -1.0 L to +0.5, i.e. the TAFO target range will be from -0.2 L to 1.3 L.
Prescription steps will be calculated weekly for all study patients. TAFO < -0.2 L: Increase post-dialytic weight by Cw x 0.5 kg/week, TAFO between -0.2 to 1.3 L: No action, TAFO between 1.3 to 2.8 L Decrease post-dialytic weight by Cw x 0.5 kg/week, TAFO > 2.8 L: Decrease post-dialytic weight by Cw x 1.0 kg/week.
What is being measured
The primary outcome is the main question the study is designed to answer.
intra-individual difference in TAFO between study start and study end
Measured: 3 months
Secondary outcomes (10)
Comparison between start and end of treatment will be performed for Pre-dialytic overhydration (OH)
Measured: 3 months
Comparison between start and end of treatment will be performed for number of patients in target range (TAFO from -0.2 L to 1.3 L)
Measured: 3 months
SF 36 total score and sub-scores as calculated according to official guidelines,
Measured: 3 months
BNP
Measured: 3 months
Blood pressure
Measured: 3 months
laboratory parameters (sodium, calcium, potassium, chloride, haematocrit, haemoglobin, albumin, total protein, urea, creatinine, mean corpuscular volume, C-reactive protein, transferrin saturation, ferritin).
Measured: 3 months
Change from Baseline in Medication at 12 weeks (erythropoetin, iron, blood pressure medication)
Measured: 3 months
Change from baseline in intra-dialytic events (hypotension, cramps)
Measured: 3 months
Change from baseline in Residual Renal Function
Baseline Residual renal function, measured as Kt/V residual, wil be compared with the Residual renal function at the end of 12 weeks.
Measured: 3 months
Hospitalisation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypotension During DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francisco Maduell
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Medical Care Europe
- Responsible party
- Sponsor-investigator, Francisco Maduell, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492634
- Sponsor's protocol ID
- HD-IIT-01-E
- Status last verified
- Dec 2011
- First submitted
- 7 Dec 2011
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Moissl U, Arias-Guillen M, Wabel P, Fontsere N, Carrera M, Campistol JM, Maduell F. Bioimpedance-guided fluid management in hemodialysis patients. Clin J Am Soc Nephrol. 2013 Sep;8(9):1575-82. doi: 10.2215/CJN.12411212. Epub 2013 Aug 15.
PubMed 23949235
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation Plan Optimizing Fluid Status
- ClinicalTrials.gov ID
- NCT01492634
- Acronym / sponsor ID
- HD-IIT-01-E
- Conditions
- Hypotension During Dialysis
- Keywords
- bioimpedance, overhydration, dry weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Francisco MaduellUniversity, hospital or other
- Collaborators
- Fresenius Medical Care Europe
- Study start
- Nov 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 15 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Title of study: Optimizing Fluid Status
Study code: HD-IIT-01-E
Study design: Prospective open design in study centre at two locations
Applied medical device: Body Composition Monitor (BCM) for determination of fluid overload and dry weight
Aim of the study: To improve the fluid status in chronic HD patients (measured as OH (overhydration) or TAFO (time averaged fluid overload)) based on BCM measurements. Up to now, the BCM was occasionally applied in both locations of the study centre.
Study hypothesis: Regular measurement of fluid status (assessed by BCM) and display of dry weight (post-weight plan)will have significant consequences, namely a decrease of the:
- time averaged fluid overload (TAFO),
- proportion of patients with severe overhydration OH > 2.5 L,or OH/ECW > 15 %)
- proportion of dehydrated patients (OH < -1.0 L, or OH < -7 %),
- mean overhydration,
- variance of overhydration,
- time outside the reference range (-1.0L < OH < 2.5L).
Devices used in this study: Dialysis machine 5008 equipped with Blood Pressure Monitor BPM, Blood Volume Monitor BVM, Blood Temperature Monitor BTM, and Online Clearance Monitor OCM ; Body Composition Monitor BCM ; Data management software / database system NephroLink Disposables used in this study: BVM blood lines and BCM electrodes
Patients: 60 patients
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic renal failure stage V
- Treatment thrice weekly with HD or on-line HDF for at least 6 months prior to inclusion
- Ability to understand the nature and requirements of the study
- Age: at least 18 years
- Signed informed consent.
Key exclusion criteria (8 listed)
- Interventional clinical study during the preceding 30 days or previous participation in the same study
- Acute or chronic infection (HIV, Hepatitis B or C, ...)
- Severe disease (malignant tumour, tuberculosis ...)
- Usually single needle HD
- Problems with shunt or high recirculation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prescription of post-dialytic weight based on BCM deviceAlso: BCM or Body Composition Monitor Fresenius Medical CarePrescription of post-dialytic weight target: On a weekly base, the patients are pre-dialytically measured by BCM (body composition monitor). The time average fluid overload (TAFO) determines the target range. TAFO is defined as the mean value of pre- and post-dialytic overhydration (TAFO = (OHpre+OHpost)/2). The target range is set asymmetrically around a TAFO of 0.8, from -1.0 L to +0.5, i.e. the TAFO target range will be from -0.2 L to 1.3 L. Prescription steps will be calculated weekly for all study patients. TAFO < -0.2 L: Increase post-dialytic weight by Cw x 0.5 kg/week, TAFO between -0.2 to 1.3 L: No action, TAFO between 1.3 to 2.8 L Decrease post-dialytic weight by Cw x 0.5 kg/week, TAFO > 2.8 L: Decrease post-dialytic weight by Cw x 1.0 kg/week. | Other | – |
Primary outcome
intra-individual difference in TAFO between study start and study end
Time frame: 3 months
10 secondary outcomes
Comparison between start and end of treatment will be performed for Pre-dialytic overhydration (OH)
Time frame: 3 months
Comparison between start and end of treatment will be performed for number of patients in target range (TAFO from -0.2 L to 1.3 L)
Time frame: 3 months
SF 36 total score and sub-scores as calculated according to official guidelines,
Time frame: 3 months
BNP
Time frame: 3 months
Blood pressure
Time frame: 3 months
laboratory parameters (sodium, calcium, potassium, chloride, haematocrit, haemoglobin, albumin, total protein, urea, creatinine, mean corpuscular volume, C-reactive protein, transferrin saturation, ferritin).
Time frame: 3 months
Change from Baseline in Medication at 12 weeks (erythropoetin, iron, blood pressure medication)
Time frame: 3 months
Change from baseline in intra-dialytic events (hypotension, cramps)
Time frame: 3 months
Change from baseline in Residual Renal Function
Time frame: 3 months
Hospitalisation
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
- Results publication: PubMed 23949235Moissl U, Arias-Guillen M, Wabel P, Fontsere N, Carrera M, Campistol JM, Maduell F. Bioimpedance-guided fluid management in hemodialysis patients. Clin J Am Soc Nephrol. 2013 Sep;8(9):1575-82. doi: 10.2215/CJN.12411212. Epub 2013 Aug 15.
Related trials for Hypotension During Dialysis
Active, not recruitingPhase 3
Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor
Intradialytic Hypotension
Recruiting
Trial of Variable Dialysate Bicarbonate
Peri-dialytic Cardiac Rhythms, Intradialytic Hypotension
Recruiting
Prospective, Multicentre, Randomized, Controlled, Cross-over Study on the Safety and Performance of the Biologic Fusion Option of DialogiQ Compared to Haemodialysis Without Biologic Fusion in Hypotension Prone Patients on Maintenance Haemodialysis
Renal Dialysis
Recruiting
Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients
End Stage Renal Disease, Hypertension
Recruiting
Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite Using Citrate- vs Acetate-based Dialysate
Intradialytic Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prescription of post-dialytic weight based on BCM device in people with Hypotension During Dialysis, run by Francisco Maduell at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intra-individual difference in TAFO between study start and study end (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01492634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2014.