Condition category
Nutritional, Metabolic, Endocrine
Date applied
31/03/2011
Date assigned
18/05/2011
Last edited
07/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/01/2003

Overall trial end date

30/06/2008

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19521079
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21360469
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22013952

Publication citations

  1. Results

    Rostoker G, Griuncelli M, Loridon C, Benmaadi A, Illouz E, Left-ventricular diastolic dysfunction as a risk factor for dialytic hypotension., Cardiology, 2009, 114, 2, 142-149, doi: 10.1159/000224776.

  2. Results

    Rostoker G, Griuncelli M, Loridon C, Bourlet T, Illouz E, Benmaadi A, A pilot study of routine colloid infusion in hypotension-prone dialysis patients unresponsive to preventive measures., J. Nephrol., 24, 2, 208-217.

  3. Results

    Rostoker G, Griuncelli M, Loridon C, Bourlet T, Illouz E, Benmaadi A, Modulation of oxidative stress and microinflammatory status by colloids in refractory dialytic hypotension., BMC Nephrol, 2011, 12, 58, doi: 10.1186/1471-2369-12-58.

Additional files

Editorial Notes