Role of diastolic dysfunction in the pathogenesis of dialytic associated hypotension and effect of systematic colloid infusion in refractory cases
| ISRCTN | ISRCTN20957055 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20957055 |
| Secondary identifying numbers | AFSSAPS n° 021059 |
- Submission date
- 31/03/2011
- Registration date
- 18/05/2011
- Last edited
- 07/12/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Guy Rostoker
Scientific
Scientific
Service de Néphrologie et de Dialyse
Hopital Privé Claude Galien
2 Rue de Boussy
Quincy sous Senart
91480
France
| Phone | +33 (0)1 69 39 92 01 |
|---|---|
| rostotom@orange.fr |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 30/06/2008 |
Eligibility
| 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 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- France
Study participating centre
Service de Néphrologie et de Dialyse
Quincy sous Senart
91480
France
91480
France
Sponsor information
Association Quincy Recherche Clinique et Therapeutique (QRCT) (France)
Charity
Charity
2 Rue du Moulin de Jarcy
Quincy sous Senart
91480
France
| Phone | +33 (0)1 69 39 91 64 |
|---|---|
| qrct@gsante.fr |
Funders
Funder type
Charity
Physicians Association of Claude Galien Hospital (Association Quincy Recherche Clinique et Thérapeutique - QRCT) (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
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 |
