Contact information
Type
Scientific
Contact name
Dr Guy Rostoker
ORCID ID
Contact details
Service de Néphrologie et de Dialyse
Hopital Privé Claude Galien
2 Rue de Boussy
Quincy sous Senart
91480
France
+33 (0)1 69 39 92 01
rostotom@orange.fr
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
AFSSAPS n° 021059
Study information
Scientific title
Determining of the role of left ventricular diastolic dysfunction and diastolic heart failure in the pathogenesis of dialytic associated hypotension and studying the benefit of routine colloid infusion in hypotension prone dialysis patients (with diastolic dysfunction), who are unresponsive to preventive measures
Acronym
Study hypothesis
The increasing number of elderly and diabetic patients and patients with cardiovascular disease may play a pivotal role in the pathogenesis of dialysis associated hypotension through left ventricular diastolic dysfunction and diastolic heart failure. The aim of this pilot study was to assess the potential benefit of systematic infusion of colloids during dialysis in hypotension prone patients who have diastolic dysfunction and are unresponsive to the usual preventive measures
Ethics approval(s)
This trial received approval n°02-017 from the ethics committee of Henri Mondor University Hospital and was registered at the French Agency for Drugs and Health Devices AFSSAPS (n° 021059). 12/06/2002
Study design
Prospective cross-sectional cohort and prospective crossover study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
End stage renal failure/hemodialysis patients/hemodynamic instability during dialysis sessions
Intervention
1. Cross-sectionnal study of hemodialysis patients: Echocardiography performed 2 hours after a dialysis session and BNP measured at the beginning of mid week dialysis session
2. Cross-over single blind study (lasting 20 weeks) of systematic infusion of 200 ml of albumine 20% and gelatine 4% during 5 weeks each separated by a washout period (lasting 5 weeks)
Intervention type
Other
Primary outcome measure
1. Cross-sectionnal study of hemodialysis patients: E/A ratio, Color M-mode diastolic flow propagation velocity (Vp)
2. Cross-over study of systematic infusion of colloids: arterial pressure regulation, i.e. Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, and the number of hypotensive episodes (defined as SBP < 100 mmHg, regardless of symptoms)
Secondary outcome measures
1. Cross-sectional study of hemodialysis patients :B-type natriuretic peptide (BNP), Cardiac index, Left-ventricular ejection fraction, Myocardial fractional shortening, Left ventricular mass index
2. Cross-over study of systematic infusion of colloids: nutritional status, ultrafiltration rate, dialysis quality microinflammatory status, oxidative stress, serum nitrate and nitrite levels
Overall study start date
01/01/2003
Overall study end date
30/06/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Hemodialysis patients
2. Age > 16 years and < 90 years
3. Dialysis vintage <10 years
4. Treated by intermittent bipuncture bicarbonate hemodialysis 3 times per week
5. Dialysis hypotension-prone patients identified in the prospective cross-sectionnal study who were unresponsive to preventive measures
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
Prospective cross-sectional study : 100 patients, prospective crossover study of colloids : 16 patients
Participant exclusion criteria
1. Left-ventricular ejection fraction < 40%
2. Malnutrition, anemia unresponsive to erythropoesis stimulating agents requiring transfusions, cancer or severe infection, inadequate dry weight assessed by echocardiography and echography of the vena cava inferior
Recruitment start date
01/01/2003
Recruitment end date
30/06/2008
Locations
Countries of recruitment
France
Study participating centre
Service de Néphrologie et de Dialyse
Quincy sous Senart
91480
France
Sponsor information
Organisation
Association Quincy Recherche Clinique et Therapeutique (QRCT) (France)
Sponsor details
2 Rue du Moulin de Jarcy
Quincy sous Senart
91480
France
+33 (0)1 69 39 91 64
qrct@gsante.fr
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Physicians Association of Claude Galien Hospital (Association Quincy Recherche Clinique et Thérapeutique - QRCT) (France)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2009 | Yes | No | |
| Results article | results | 01/03/2011 | Yes | No | |
| Results article | results | 20/10/2011 | Yes | No |